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Trial record 1 of 1 for:    NCT00848354
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Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

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ClinicalTrials.gov Identifier: NCT00848354
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : April 19, 2012
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 20, 2009
Results First Submitted Date  ICMJE February 2, 2012
Results First Posted Date  ICMJE April 19, 2012
Last Update Posted Date January 18, 2016
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
American College of Rheumatology (ACR) response [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT00848354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
  • Change From Baseline in HAQ Score at Week 24 [ Time Frame: 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.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 [ Time Frame: 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.
  • Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Summary of Changes in Therapy at the Beginning of Phase 2 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24 [ Time Frame: 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.
  • Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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
  • 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 [ Time Frame: 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
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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
  • 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 [ Time Frame: 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
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 [ Time Frame: 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).
  • 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 [ Time Frame: 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).
  • Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24 [ Time Frame: 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.
  • Change From Baseline in Erosion Score Using vdH mTSS at Week 24 [ Time Frame: 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.
  • Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 [ Time Frame: 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.
  • Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
  • Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Safety will be measured based on the number of Adverse Events and Serious Adverse Events [ Time Frame: 28 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Biological: Phase 1: Etanercept
    Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
    Other Name: Enbrel
  • Drug: Phase 1: Methotrexate
    Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
  • Drug: 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.

  • Drug: Phase 1: Methotrexate
    Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Phase 1 Etanercept + methotrexate
    Phase 1: Etanercept + methotrexate
    Interventions:
    • Biological: Phase 1: Etanercept
    • Drug: Phase 1: Methotrexate
    • Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX
  • Active Comparator: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
    Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
    Interventions:
    • Drug: Phase 1: Methotrexate
    • Drug: Phase 1: Conventiaonal DMARD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2013)
429
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2009)
414
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Colombia,   Mexico,   Panama
Removed Location Countries Brazil,   Ecuador,   Spain,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00848354
Other Study ID Numbers  ICMJE 0881A1-4532
B1801004 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Amgen
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP