Het duurt sowieso nog even Gilead gaat echt wel kijken naar 24 weeks lijkt me
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Primary Outcome Measures :Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 [ Time Frame: Week 12 ]
Secondary Outcome Measures :Proportion of Participants who Achieve Disease Activity Score based on 28 joints (DAS28) (C-reactive protein (CRP)) = 3.2 at Week 12 [ Time Frame: Week 12 ]
Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 [ Time Frame: Week 12 ]
Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
Proportion of Participants who Achieve ACR20 at Weeks 4 and 24 [ Time Frame: Weeks 4 and 24 ]
Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Change from Baseline in Individual Components of the ACR Response at Weeks 4, 12, and 24 and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Proportion of Participants who Achieve Change in HAQ-DI of = 0.22 at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Change from Baseline in DAS28 (CRP) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Proportion of Participants who Achieve DAS28 (CRP) = 3.2 at Weeks 4, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Weeks 4, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
American College of Rheumatology N (ACR-N) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
Change from Baseline in Clinical Diagnostic Activity Index (CDAI) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Change from Baseline in Simplified Diagnostic Activity Index (SDAI) at Weeks 4, 12, and 24, and over time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Absolute Value and Change from Baseline in Short-form Health Survey (SF-36) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Absolute Value and Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Absolute Value and Change from Baseline in the EuroQol 5 Dimensions (EQ-5D) Patient-Reported Outcomes Survey at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Absolute Value and Change from Baseline in Work Productivity and Activity Impairment- Rheumatoid Arthritis (WPAI-RA) at Weeks 4, 12, 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]