Phase 2
Completed N=264
Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
Source: ClinicalTrials.gov NCT00147498 ↗Enrolled (actual)
264
Serious AEs
3.8%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 — 70.49; 81.16; 76.81; 29.23 percentage of participants
Summary
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 |
70.49; 81.16; 76.81; 29.23 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
27.87; 43.48; 56.52; 12.31; 50.82; 71.01 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
6.56; 8.70; 18.84; 3.08; 9.84; 23.19 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
1.64; 4.35; 4.35; 0.00; 4.92; 4.35 | — |
| SECONDARY Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve |
857.50; 1086.90; 1211.93; -546.41 | — |
| SECONDARY Tender Joints Count (TJC) |
32.37; 26.98; 29.52; 30.61; 23.49; 16.62 | — |
| SECONDARY Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8 |
-7.06; -11.70; -14.14; -2.74; -11.68; -15.66 | — |
| SECONDARY Swollen Joints Count (SJC) |
21.33; 16.42; 19.53; 19.97; 14.77; 9.90 | — |
| SECONDARY Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8 |
-5.02; -8.20; -9.00; -3.19; -7.83; -11.33 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis |
71.03; 69.37; 63.99; 65.73; 49.89; 45.36 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8 |
-17.98; -21.56; -26.16; -5.18; -22.06; -25.71 | — |
| SECONDARY Physician Global Assessment of Arthritis |
69.39; 64.11; 66.65; 67.75; 49.85; 37.80 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8 |
-17.13; -28.25; -30.89; -12.25; -25.43; -36.60 | — |
| SECONDARY Patient Assessment of Arthritis Pain |
69.46; 67.47; 68.13; 64.17; 51.76; 46.11 | — |
| SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8 |
-15.01; -19.74; -29.66; -3.30; -21.44; -26.10 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.75; 1.66; 1.61; 1.71; 1.46; 1.37 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8 |
-0.25; -0.30; -0.44; -0.05; -0.39; -0.50 | — |
| SECONDARY C-Reactive Protein (CRP) |
31.25; 25.47; 28.10; 22.28; 15.98; 7.57 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8 |
-15.28; -18.29; -21.38; -0.24; -16.74; -18.89 | — |
| SECONDARY Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
6.17; 5.69; 5.91; 6.00; 5.29; 4.42 | — |
| SECONDARY Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8 |
-0.84; -1.28; -1.65; -0.39; -1.19; -1.91 | — |
| SECONDARY Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) |
31; 25; 17; 35; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
Exclusion Criteria
- Current Therapy With Any DMARD Or Biologic
Data sourced from ClinicalTrials.gov (NCT00147498). 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.