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Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

11 dicembre 2015 aggiornato da: Pfizer

A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.

The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

429

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, 1280
        • Hospital Britanico
      • Buenos Aires, Argentina, 1015
        • OMI
      • Buenos Aires, Argentina, 1055
        • Centro de Investigaciones en Enfermedades Reumaticas
      • Buenos Aires, Argentina, 1426
        • Atencion Integral en Reumatologia
      • Ciudad Autónoma de Buenos Aires, Argentina, C1114AAH
        • Investigaciones Reumatológicas y Osteológicas
      • Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
        • Centro de Osteopatias Medicas
      • Cordoba, Argentina, 5000
        • Sanatorio Mayo
      • Corrientes, Argentina, 3400
        • Hospital Escuela Gral. San Martin
      • San Miguel de Tucuman, Argentina, 4000
        • Centro Médico Privado de Reumatología
      • Tucuman, Argentina, 4000
        • Centro de Investigaciones Reumatológicas
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1425EKF
        • Consultorios Especializados en Investigaciones Medicas
    • Provinica de San Juan
      • San Juan, Provinica de San Juan, Argentina, 5400
        • Cer San Juan
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBJ
        • Instituto CAICI
  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Hospital del Salvador
      • Santiago, Region Metropolitana, Chile
        • Dr Miranda Private Practice
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Reumalab
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Centro de Reumatologia y Ortopedia
      • Barranquilla, Atlantico, Colombia
        • IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1
      • Barranquilla, Atlantico, Colombia
        • IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Fundacion Instituto de Reumatologia Fernando Chalem
      • Bogota, Cundinamarca, Colombia, 0000
        • Centro Integral de Reumatologia e Inmunologia LTDA
      • Bogota, Cundinamarca, Colombia
        • Foqus Ips Ltda
      • Bogota, Cundinamarca, Colombia
        • Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion
      • Chia, Cundinamarca, Colombia
        • Preventive Care Ltda
    • Santander
      • Bucaramanga, Santander, Colombia
        • Centro Medico Carlos Ardila Lulle
      • Bucaramanga, Santander, Colombia
        • Servimed EU
  • Messico
      • Chihuahua, Messico, 31000
        • Hospital Christus Muguerza del Parque
      • Chihuahua, Messico, 31000
        • Centro de Investigación y Biomedicina de Chihuahua
      • Chihuahua, Messico, 31000
        • Hospital Christus Mugerza
    • Jalisco
      • Guadajara, Jalisco, Messico, 45040
        • Hospital Angeles Chapalita
    • Yucatan
      • Merida, Yucatan, Messico
        • Centro de Especialidades Medicas del Sureste SA de CV
  • Panama
      • Panama, Panama
        • Centro de Infusion Marbella
      • Panama, Panama
        • Centro de Investigacion Marbella

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 69 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA)
  • Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
  • Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
  • Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Phase 1 Etanercept + methotrexate
Phase 1: Etanercept + methotrexate
Biologico: Phase 1: Etanercept
Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
Altri nomi:
  • Enbrel
Droga: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Droga: Phase 2: Optional ETN, SSZ, HCQ, MTX

Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.

Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.

Droga: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Comparatore attivo: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
Droga: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Droga: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Droga: Phase 1: Conventiaonal DMARD
Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
Lasso di tempo: Week 24
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).
Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in HAQ Score at Week 24
Lasso di tempo: Baseline and Week 24
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.
Baseline and Week 24
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24
Lasso di tempo: Baseline and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Baseline and Week 24
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24
Lasso di tempo: Baseline and Week 24
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and Week 24
Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Summary of Changes in Therapy at the Beginning of Phase 2
Lasso di tempo: Week 24
The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.
Week 24
Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24
Lasso di tempo: Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 24
Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24
Lasso di tempo: Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 24
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:

  • DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
  • DAS-value >3.7 and DAS-improvement from Baseline >1.2
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:

  • DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
  • DAS-value >3.7 and DAS-improvement from Baseline >1.2
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:

  • DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
  • DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:

  • DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
  • DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24
Lasso di tempo: Week 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Week 24
Change From Baseline in Erosion Score Using vdH mTSS at Week 24
Lasso di tempo: Week 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Week 24
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Lasso di tempo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Lasso di tempo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128
Lasso di tempo: Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 50, Week 76, Week 102, and Week 128
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128
Lasso di tempo: Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 50, Week 76, Week 102, and Week 128
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128
Lasso di tempo: Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 50, Week 76, Week 102, and Week 128
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24
Lasso di tempo: Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Week 8, Week 16, and Week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Collaboratori

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2009

Completamento primario (Effettivo)

1 aprile 2013

Completamento dello studio (Effettivo)

1 aprile 2013

Date di iscrizione allo studio

Primo inviato

18 febbraio 2009

Primo inviato che soddisfa i criteri di controllo qualità

19 febbraio 2009

Primo Inserito (Stima)

20 febbraio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 gennaio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 dicembre 2015

Ultimo verificato

1 dicembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0881A1-4532
  • B1801004 (Altro identificatore: Alias Study Number)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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Sedi

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