Phase 3
Completed N=487
Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
Source: ClinicalTrials.gov NCT00661661 ↗Enrolled (actual)
487
Serious AEs
28.6%
Results posted
May 2015
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 371; 105; 476; 111 Particiants
Summary
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
371; 105; 476; 111; 28; 139 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
80.2; 68.6; 77.6; 87.1; 70.5; 83.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
59.5; 36.2; 54.5; 63.8; 35.2; 57.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
37.0; 19.0; 33.1; 44.8; 20.2; 39.3 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.55; -0.44; -0.53; -0.61; -0.45; -0.57 | — |
| SECONDARY Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
-2.60; -1.94; -2.45; -2.77; -1.95; -2.59 | — |
| SECONDARY Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
-2.44; -1.90; -2.32; -2.55; -1.90; -2.41 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Arthritis |
-34.52; -25.38; -32.54; -37.81; -25.34; -35.06 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Arthritis |
-42.80; -33.49; -40.78; -46.06; -34.91; -43.60 | — |
| SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain |
-34.23; -27.98; -32.87; -37.32; -27.70; -35.20 | — |
| SECONDARY Change From Baseline in Tender/Painful Joint Counts |
-11.88; -10.17; -11.51; -12.13; -10.46; -11.77 | — |
| SECONDARY Change From Baseline in Swollen Joint Counts |
-9.67; -8.69; -9.46; -10.12; -8.54; -9.78 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning |
7.87; 5.94; 7.45; 8.67; 6.12; 8.10 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical |
7.31; 5.48; 6.90; 8.21; 6.29; 7.77 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain |
11.40; 8.13; 10.40; 11.87; 9.63; 11.36 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health |
6.07; 4.24; 5.67; 6.38; 5.00; 6.07 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality |
7.37; 6.61; 7.20; 7.24; 6.25; 7.02 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning |
4.99; 5.17; 5.03; 5.57; 4.96; 5.44 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional |
6.65; 4.98; 6.28; 6.88; 4.40; 6.32 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health |
6.27; 5.38; 6.08; 6.22; 3.84; 5.69 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical |
8.44; 6.09; 7.92; 9.39; 7.56; 8.98 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental |
5.13; 4.82; 5.06; 4.95; 3.38; 4.60 | — |
| SECONDARY Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) |
0.17; 0.50; 0.20; 0.27; 1.75; 0.41 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Exclusion Criteria
- Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Data sourced from ClinicalTrials.gov (NCT00661661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.