Back to resultsStudy Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Primary Purpose
Active Rheumatoid Arthritis, Arthritis, Rheumatoid, Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Active Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of early rheumatoid arthritis.
- Methotrexate (MTX) naive.
- Active early rheumatoid arthritis at the time of enrollment.
Exclusion Criteria:
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
- Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
etanercept + methotrexate; etanercept + methotrexate
Outcomes
Primary Outcome Measures
Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score
Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.
The participants who met sustained remission in both Week 76 and 91 are presented here.
Secondary Outcome Measures
Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
The composite measure of complete response over the last 3 months of Phase 1 was defined as:
DAS28 <2.6 at the week 39 and 52 visits and,
No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,
Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy
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). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. 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 Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Change From Baseline in Physician's Global Assessment of Disease Activity
Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.
Change From Baseline in Participant's Global Assessment of Disease Activity
Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity
Change From Baseline in DAS44 Score at All Visits
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit
The PASS is defined as a symptom state that the participants consider acceptable.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement 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; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
The composite measure of complete response over the last 3 months of Phase 2 was defined as:
DAS28 <2.6 at the Week 76 and Week 91 visits and
No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.
Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is 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.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder
Physician's Global Assessment of Disease Activity
Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.
Participant's Global Assessment of Disease Activity
Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity
Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)
100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.
Number of Participants Achieving Patient Acceptable Symptom State (PASS)
The PASS is defined as a symptom state that the subjects consider acceptable.
Modified Total Sharp Score (mTSS) at Week 52
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). Change: scores at observation minus score at baseline. 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 mTSS at Week 91 and Final on Therapy
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). Change: scores at observation minus score at baseline. 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.
Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913458
Brief Title
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Official Title
A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis, Arthritis, Rheumatoid, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
etanercept + methotrexate; etanercept + methotrexate
Intervention Type
Drug
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Primary Outcome Measure Information:
Title
Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score
Description
Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.
The participants who met sustained remission in both Week 76 and 91 are presented here.
Time Frame
76 and 91 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
Description
The composite measure of complete response over the last 3 months of Phase 1 was defined as:
DAS28 <2.6 at the week 39 and 52 visits and,
No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,
Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits
Time Frame
End of Phase 1
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy
Description
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). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. 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.
Time Frame
52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem
Description
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem
Description
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem
Description
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem
Description
WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response
Description
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response
Description
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response
Description
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response
Description
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Physician's Global Assessment of Disease Activity
Description
Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in Participant's Global Assessment of Disease Activity
Description
Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Change From Baseline in DAS44 Score at All Visits
Description
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission
Description
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
Description
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit
Description
The PASS is defined as a symptom state that the participants consider acceptable.
Time Frame
2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)
Title
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
Description
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement 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; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Description
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission
Description
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity
Description
DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)
Description
The composite measure of complete response over the last 3 months of Phase 2 was defined as:
DAS28 <2.6 at the Week 76 and Week 91 visits and
No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.
Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is 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.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder
Time Frame
52 and 91 weeks
Title
Physician's Global Assessment of Disease Activity
Description
Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Participant's Global Assessment of Disease Activity
Description
Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)
Description
100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Number of Participants Achieving Patient Acceptable Symptom State (PASS)
Description
The PASS is defined as a symptom state that the subjects consider acceptable.
Time Frame
52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Modified Total Sharp Score (mTSS) at Week 52
Description
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). Change: scores at observation minus score at baseline. 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.
Time Frame
52 weeks
Title
Change From Baseline mTSS at Week 91 and Final on Therapy
Description
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). Change: scores at observation minus score at baseline. 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.
Time Frame
91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)
Title
Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
52 weeks
Title
Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem
Description
WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
Title
WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
52 Weeks
Title
Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
Title
WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
52 weeks
Title
Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
Title
WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
52 weeks
Title
Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem
Description
WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.
Time Frame
64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of early rheumatoid arthritis.
Methotrexate (MTX) naive.
Active early rheumatoid arthritis at the time of enrollment.
Exclusion Criteria:
Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier Cedex 05
ZIP/Postal Code
34293
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Pfizer Investigational Site
City
Vogelsang
State/Province
Gommern
ZIP/Postal Code
39245
Country
Germany
Facility Name
Pfizer Investigational Site
City
Elmshorn
ZIP/Postal Code
25335
Country
Germany
Facility Name
Pfizer Investigational Site
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Pfizer Investigational Site
City
Halle
ZIP/Postal Code
06128
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg-Altona
ZIP/Postal Code
22767
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22147
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ludwigsfelde
ZIP/Postal Code
14974
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Zerbst
ZIP/Postal Code
39261
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 4
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
Facility Name
Pfizer Investigational Site
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bydgoszczy
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Pfizer Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Ustron
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zyrardow
ZIP/Postal Code
96-300
Country
Poland
Facility Name
Pfizer Investigational Site
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Facility Name
Pfizer Investigational Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
010584
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
020983
Country
Romania
Facility Name
Pfizer Investigational Site
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Pfizer Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Pfizer Investigational Site
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
St. Gallen
State/Province
SG
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Wigan
State/Province
Lancaster
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31277720
Citation
Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.
Results Reference
derived
PubMed Identifier
28255449
Citation
Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.
Results Reference
derived
PubMed Identifier
27486524
Citation
Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.
Results Reference
derived
PubMed Identifier
27252426
Citation
Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.
Results Reference
derived
PubMed Identifier
26535135
Citation
Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.
Results Reference
derived
PubMed Identifier
25372086
Citation
Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881X1-4524&StudyName=Study%20Evaluating%20Etanercept%20plus%20Methotrexate%20in%20Early%20Rheumatoid%20Arthritis
Description
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Learn more about this trial
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
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