Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

6 maj 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

686

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Tofacitinib
Läkemedel: Tofacitinib
Tofacitinib 5 mg tablet twice daily
Läkemedel: Tofacitinib
Tofactinib 10 mg tablet twice daily
Läkemedel: Methotrexate
Methotrexate 7.5-20 mg weekly
Andra namn:
  • Understudie
Läkemedel: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Andra namn:
  • Understudie

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 februari 2014

Primärt slutförande (Faktisk)

20 maj 2019

Avslutad studie (Faktisk)

20 maj 2019

Studieregistreringsdatum

Först inskickad

29 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

29 oktober 2013

Första postat (Uppskatta)

5 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 maj 2020

Senast verifierad

1 maj 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A3921092
  • 2011-002169-39 (EudraCT-nummer)
  • OPAL BALANCE (Annan identifierare: Alias Study Number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera