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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

6. května 2020 aktualizováno: Pfizer

A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

686

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • New South Wales
      • Camperdown, New South Wales, Austrálie, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Maroochydore, Queensland, Austrálie, 4558
        • Rheumatology Research Unit
      • Southport, Queensland, Austrálie, 4215
        • Pacific Private Clinic
    • Victoria
      • Camberwell, Victoria, Austrálie, 3124
        • Emeritus Research
      • Fitzroy, Victoria, Austrálie, 3065
        • St. Vincent's Hospital
      • Fitzroy, Victoria, Austrálie, 3065
        • St. Vincent's Hospital (Melbourne)
  • Belgie
      • Brussels, Belgie, 1070
        • Hopital Erasme - Clinique Universitaire de Bruxelles
      • Genk, Belgie, 3600
        • ReumaClinic
      • Gent, Belgie, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgie, 3000
        • University Hospital Leuven
      • Merksem, Belgie, 2170
        • ZNA Jan Palfijn
    • Brabant Flamand
      • Brussels, Brabant Flamand, Belgie, 1070
        • Hopital Erasme - Clinique Universitaire de Bruxelles
  • Brazílie
    • MG
      • Juiz de Fora, MG, Brazílie, 36010-570
        • CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
    • PR
      • Curitiba, PR, Brazílie, 80440-080
        • EDUMED - Educacao em Saude SS Ltda
    • RS
      • Porto Alegre, RS, Brazílie, 90035-903
        • Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
  • Bulharsko
      • Pleven, Bulharsko, 5800
        • UMHAT "Dr. G. Stranski" EAD, Department of Rheumatology
      • Plovdiv, Bulharsko, 4000
        • Multiprofile Hospital for Active Treatment - Plovdiv AD
      • Plovdiv, Bulharsko, 4002
        • Multiprofile hospital for active treatment Kaspela EOOD
      • Stara Zagora, Bulharsko, 6003
        • Medical Center - "New rehabilitation center" EOOD
  • Kanada
    • Ontario
      • Waterloo, Ontario, Kanada, N2J 1C4
        • K. Papp Clinical Research
  • Maďarsko
      • Budapest, Maďarsko, 1027
        • Revita Reumatologiai Rendelo
      • Budapest, Maďarsko, 1036
        • Qualiclinic Kft.
      • Budapest, Maďarsko, 1024
        • Diagnoscan Magyarorszag Kft.
      • Budapest, Maďarsko, 1027
        • Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang
      • Budapest, Maďarsko, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly
      • Budapest, Maďarsko, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly
      • Veszprem, Maďarsko, 8200
        • Csolnoky Ferenc Korhaz
      • Veszprem, Maďarsko, 8200
        • Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
  • Mexiko
      • Chihuahua, Mexiko, 31000
        • Investigacion y Biomedicina de Chihuahua SC
      • Chihuahua, Mexiko, 31000
        • Christus Muguerza del Parque S.A. de C.V.
    • D.F
      • Mexico City, D.F, Mexiko, 06700
        • Hospital Angeles Clinica Londres
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexiko, 03310
        • Grupo Medico Camino S.C.
      • Mexico City, Distrito Federal, Mexiko, 06700
        • CLIDITER, S.A. de C.V.
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44160
        • Centro Integral en Reumatología S.A. de C.V.
    • Sinaloa
      • Culiacan, Sinaloa, Mexiko, 80000
        • Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
      • Culiacan, Sinaloa, Mexiko, 80230
        • Hospital General de Culiacan Dr. Bernardo J. Gastelum
      • Culiacan, Sinaloa, Mexiko, 80040
        • Sanatorio CEMSI Chapultepec
    • Yucatan
      • Merida, Yucatan, Mexiko, 97000
        • Unidad Reumatologica las Americas S.C.P.
      • Merida, Yucatan, Mexiko, 97000
        • Instituto Medico Panamericano, S.A de C.V.
      • Merida, Yucatan, Mexiko, 97130
        • Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En
  • Německo
      • Berlin, Německo, 12161
        • Rheumapraxis Steglitz
      • Berlin, Německo, 14059
        • Schlosspark-Klinik
      • Berlin, Německo, 10117
        • Klinische Forschung Berlin-Mitte GmbH
      • Berlin, Německo, 10117
        • Charité Universitaetsmedizin Berlin
      • Frankfurt am Main, Německo, 60598
        • CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)
      • Freiburg, Německo, 79106
        • Medizinische Universitaetsklinik Freiburg
      • Homburg, Německo, 66421
        • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
      • Koeln, Německo, 50937
        • University Hospital of Cologne
      • Olsberg, Německo, 59939
        • Elisabeth Klinik Bigge
    • Mecklenburg-vorp
      • Bad Doberan, Mecklenburg-vorp, Německo, 18209
        • Rheumazentrum Prof. Dr. med Gunther Neeck
  • Polsko
      • Bialystok, Polsko, 15-879
        • ClinicMed Daniluk, Nowak Spolka Jawna
      • Bialystok, Polsko, 15-351
        • ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
      • Bialystok, Polsko, 15-002
        • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.
      • Bydgoszcz, Polsko, 85-168
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
      • Elblag, Polsko, 82-300
        • NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
      • Elblag, Polsko, 82-300
        • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
      • Elblag, Polsko, 82-300
        • Centrum Radiologii
      • Elblag, Polsko, 82-300
        • Wojewodzki Szpital Zespolony, Zaklad Radiologii
      • Grodzisk Mazowiecki, Polsko, 05-825
        • Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
      • Lodz, Polsko, 90-265
        • Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
      • Lublin, Polsko, 20-582
        • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
      • Lublin, Polsko, 20-601
        • Top-Medical Sp. z o. o.
      • Nadarzyn, Polsko, 05-830
        • NZOZ Lecznica MAK-MED S.C.
      • Poznan, Polsko, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
      • Torun, Polsko, 87-100
        • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
      • Warszawa, Polsko, 02-691
        • Reumatika Centrum Reumatologii NZOZ
      • Warszawa, Polsko, 02-118
        • Rheuma-Medicus Zaklad Opieki Zdrowotnej
      • Wroclaw, Polsko, 50-381
        • Synexus Polska Oddzial we Wroclawiu
    • Mazowieckie
      • Warszawa, Mazowieckie, Polsko, 01-868
        • Centrum Medyczne Pratia S.A. Warszawa
  • Ruská Federace
      • Moscow, Ruská Federace, 119049
        • SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
      • Novosibirsk, Ruská Federace, 630099
        • Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
      • Novosibirsk, Ruská Federace, 630047
        • Research Institution of Fundamental and Clinical Immunology
      • Petrozavodsk, Ruská Federace, 185019
        • Regional State Budgetary Health Care Institution of Karelia Republic
      • Saratov, Ruská Federace, 410053
        • State Institution of Healthcare Regional Clinical Hospital
      • Tomsk, Ruská Federace, 634050
        • State Budget Educational Institution of Highest Professional Education
      • Yaroslavl, Ruská Federace, 150003
        • State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical
      • Yaroslavl, Ruská Federace, 150003
        • State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a.N.V. Solovyev
    • Republic OF Tatarstan
      • Kazan, Republic OF Tatarstan, Ruská Federace, 420103
        • State Autonomic Healthcare Institution ''City Clinical Hospital # 7''
  • Slovensko
      • Bratislava, Slovensko, 841 04
        • Neštátna Reumatologická Ambulancia
      • Martin, Slovensko, 03601
        • MEDMAN s.r.o. - reumatologicka ambulancia
      • Rimavska Sobota, Slovensko, 979 01
        • REUMEX, s.r.o
  • Spojené království
      • Bath, Spojené království, BA1 1 RL
        • Royal United Hospitals NHS Foundation Trust
      • York, Spojené království, YO31 8HE
        • York Teaching Hospital NHS Foundation Trust
    • Essex
      • Goodmayes, Essex, Spojené království, IG3 8YB
        • Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
      • Romford, Essex, Spojené království, RM7 0AG
        • Barking Havering and Redbridge University Hospitals NHS Trust
    • WEST Midlands
      • Dudley, WEST Midlands, Spojené království, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
    • WEST Yorkshire
      • Bradford, WEST Yorkshire, Spojené království, BD5 0NA
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Bradford, WEST Yorkshire, Spojené království, BD96RJ
        • Bradford Royal lnfirmary, BTHFT
    • Wirral
      • Upton, Wirral, Spojené království, CH49 5PE
        • Wirral University Teaching Hospital NHS Foundation Trust
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35205
        • Rheumatology Associates, Pc
      • Huntsville, Alabama, Spojené státy, 35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Glendale, Arizona, Spojené státy, 85306
        • Arizona Arthritis & Rheumatology Associates, P.C.
    • California
      • Fullerton, California, Spojené státy, 92835
        • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
      • Palm Desert, California, Spojené státy, 92260
        • Desert Medical Advances
      • San Diego, California, Spojené státy, 92108
        • San Diego Arthritis Medical Clinic
      • Stanford, California, Spojené státy, 94305
        • Stanford University Hospitals and Clinics
      • Stanford, California, Spojené státy, 94305
        • Stanford Anatomic Pathology and Clinical Lab
      • Stanford, California, Spojené státy, 94305
        • Stanford Health Care Department of Pharmacy lnvestigational Drug Services
    • Connecticut
      • Bridgeport, Connecticut, Spojené státy, 06606
        • New England Research Associates, LLC
    • Florida
      • Orlando, Florida, Spojené státy, 32806
        • Rheumatology Associates of Central Florida, PA
      • Ormond Beach, Florida, Spojené státy, 32174
        • Millennium Research
      • Palm Harbour, Florida, Spojené státy, 34684
        • Arthritis Center, Inc.
      • Plantation, Florida, Spojené státy, 33324
        • Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists
      • Zephyrhills, Florida, Spojené státy, 33542
        • Florida Medical Clinic, P.A.
    • Idaho
      • Boise, Idaho, Spojené státy, 83702
        • St. Luke's Clinic - Rheumatology
      • Boise, Idaho, Spojené státy, 83702
        • St. Luke's Intermountain Research Center
    • Kentucky
      • Lexington, Kentucky, Spojené státy, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Hagerstown, Maryland, Spojené státy, 21740
        • Klein and Associates, M.D., P.A.
      • Wheaton, Maryland, Spojené státy, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02115
        • Brigham & Women's Hospital
      • Worcester, Massachusetts, Spojené státy, 01605
        • Clinical Pharmacology Study Group
    • Minnesota
      • Eagan, Minnesota, Spojené státy, 55121
        • St. Paul Rheumatology, P.A.
    • Missouri
      • Saint Louis, Missouri, Spojené státy, 63117
        • Clayton Medical Research
    • Nebraska
      • Lincoln, Nebraska, Spojené státy, 68516
        • Physician Research Collaboration, LLC
    • New Hampshire
      • Lebanon, New Hampshire, Spojené státy, 03756
        • Dartmouth-Hitchcock Medical Center
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45242
        • Cincinnati Rheumatic Disease Study Group, Inc.
      • Cleveland, Ohio, Spojené státy, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, Spojené státy, 44106
        • University Hospitals of Cleveland Medical Center
      • Middleburg Heights, Ohio, Spojené státy, 44130
        • Paramount Medical Research & Consulting, LLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, Spojené státy, 18015
        • East Penn Rheumatology Associates, Pc
      • Duncansville, Pennsylvania, Spojené státy, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Summerville, South Carolina, Spojené státy, 29486
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
    • Tennessee
      • Jackson, Tennessee, Spojené státy, 38305
        • Arthritis Clinic
      • Jackson, Tennessee, Spojené státy, 38305
        • West Tennessee Research Institute
    • Texas
      • Corpus Christi, Texas, Spojené státy, 78404
        • Adriana Pop-Moody MD Clinic PA
      • Cypress, Texas, Spojené státy, 77429
        • Pioneer Research Solutions, Inc.
    • Utah
      • Salt Lake City, Utah, Spojené státy, 84132
        • University of Utah Hospital & Clinics
      • Salt Lake City, Utah, Spojené státy, 84112
        • Investigational Drug Services
      • Salt Lake City, Utah, Spojené státy, 84132
        • University of Utah Hospitals and Clinics - Clinie 2
    • Washington
      • Seattle, Washington, Spojené státy, 98122
        • Swedish Medical Center
      • Seattle, Washington, Spojené státy, 98122
        • Seattle Rheumatology Associates
      • Seattle, Washington, Spojené státy, 98104
        • Swedish Medical Center
  • Tchaj-wan
      • Chia-Yi, Tchaj-wan, 62247
        • Buddhist Dalin Tzu Chi General Hospital
      • Kaohsiung City, Tchaj-wan, 83301
        • Chang Gung Medical Foundation-Kaohsiung Branch
      • Taichung, Tchaj-wan, 40201
        • Chung Shan Medical University Hospital
      • Taipei, Tchaj-wan, 11217
        • Taipei Veterans General Hospital
  • Česko
      • Brno, Česko, 615 00
        • Revmacentrum MUDr. Mostera, s.r.o.
      • Brno, Česko, 613 00
        • X-Medica, s.r.o.
      • Brno, Česko, 63800
        • Revmatologie s.r.o.
      • Brno, Česko, 638 00
        • Stavovska, s.r.o.
      • Ostrava, Česko, 702 00
        • Vesalion s.r.o.
      • Praha 2, Česko, 128 50
        • Revmatologicky Ustav
      • Praha 2, Česko, 128 50
        • Revmatologicky ustav - Lekarna
      • Praha 4, Česko, 140 00
        • Revmatologicka ambulance
      • Uherske Hradiste, Česko, 686 01
        • MEDICAL PLUS, s.r.o.
  • Španělsko
      • A Coruna, Španělsko, 15006
        • Complexo Hospitalario Universitario A Coruña
      • Barcelona, Španělsko, 08035
        • Hospital Universitari Vall d'Hebron
      • Sevilla, Španělsko, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Španělsko, 41010
        • Hospital Quiron Salud Infanta Luisa
      • Valencia, Španělsko, 46026
        • Hospital Universitario y Politécnico La Fe
    • A Coruna
      • Santiago de Compostela, A Coruna, Španělsko, 15706
        • Hospital Clínico de Santiago
    • Barcelona
      • Sabadell, Barcelona, Španělsko, 08208
        • Corporacio Sanitaria Parc Tauli
    • Cantabria
      • Santander, Cantabria, Španělsko, 39008
        • Hospital Universitario Marqués de Valdecilla

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

  • Time from End of Study visit of qualifying study is >3 months.
  • Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.

Sub-study Inclusion Criteria:

  • Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
  • Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Tofacitinib
Lék: Tofacitinib
Tofacitinib 5 mg tablet twice daily
Lék: Tofacitinib
Tofactinib 10 mg tablet twice daily
Lék: Methotrexate
Methotrexate 7.5-20 mg weekly
Ostatní jména:
  • Subtudy
Lék: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Ostatní jména:
  • Subtudy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Number of Adverse Events (AEs) by Severity
Časové okno: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Number of Participants With Abnormal Clinical Laboratory Values
Časové okno: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Časové okno: Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.
Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Časové okno: Sub-study: Baseline (Day 1), Month 6
HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Sub-study: Baseline (Day 1), Month 6
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
Časové okno: Sub-study: Baseline (Day 1), Month 6
PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Sub-study: Baseline (Day 1), Month 6

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
Časové okno: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response
Časové okno: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response
Časové okno: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Časové okno: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.
Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.
Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Časové okno: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12
Časové okno: Months 1, 3, 6, 9 and 12
PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12
Časové okno: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Months 1, 3, 6, 9 and 12
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Sub-study: Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Months 1, 3, 6, 9 and 12
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Months 1, 3, 6, 9 and 12
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Months 1, 3, 6, 9 and 12
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Months 1, 3, 6, 9 and 12
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Months 1, 3, 6, 9 and 12
A psoriatic arthritis participant was considered with minimal disease activity if participant had >= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (<=) 1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1.
Sub-study: Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator's response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participant's response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Participants assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher score indicated more severe pain.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this measure.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12
Časové okno: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. února 2014

Primární dokončení (Aktuální)

20. května 2019

Dokončení studie (Aktuální)

20. května 2019

Termíny zápisu do studia

První předloženo

29. října 2013

První předloženo, které splnilo kritéria kontroly kvality

29. října 2013

První zveřejněno (Odhad)

5. listopadu 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. května 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2020

Naposledy ověřeno

1. května 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A3921092
  • 2011-002169-39 (Číslo EudraCT)
  • OPAL BALANCE (Jiný identifikátor: Alias Study Number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Drogové intervence

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CROs in Brazil

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

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