A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

简要总结

主要结局

次要结局

• Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response(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))
• Change From Baseline in Participant's Global Assessment of Disease Activity(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))
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem(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))
• Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)(End of Phase 1)
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem(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))
• Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response(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))
• Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy(52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at))
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem(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))
• Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response(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))
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem(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))
• Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response(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))
• Change From Baseline in DAS44 Score at All Visits(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))
• Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit(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))
• Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response(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))
• Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)(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))
• Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response(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))
• Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission(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))
• Participant's Global Assessment of Disease Activity(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))
• Change From Baseline mTSS at Week 91 and Final on Therapy(91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at))
• Change From Baseline in Physician's Global Assessment of Disease Activity(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))
• Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission(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))
• Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity(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))
• Number of Participants With an American College of Rheumatology 20% (ACR20) Response(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))
• Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)(52 and 91 weeks)
• Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response(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))
• Physician's Global Assessment of Disease Activity(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))
• Number of Participants Achieving Patient Acceptable Symptom State (PASS)(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))
• Modified Total Sharp Score (mTSS) at Week 52(52 weeks)
• Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem(64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at))
• Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem(64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at))
• Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem(52 weeks)
• WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem(52 Weeks)
• WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem(52 weeks)
• WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem(52 weeks)
• Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem(64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at))
• Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem(64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at))