Phase 2
Completed N=509
Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00413660 ↗
Enrolled (actual)
509
Serious AEs
4.1%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 47.14; 55.88; 56.34; 58.11 percentage of participants
Summary
The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
47.14; 55.88; 56.34; 58.11; 56.00; 56.25 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
21.43; NA; 36.76; NA; 30.99; 31.08 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
1.43; NA; 5.88; NA; 5.63; 4.05 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
1.43; NA; 1.47; NA; 1.41; 1.35 | — |
| SECONDARY Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve |
-14.07; 22.16; 4.47; -21.34; 88.72; 36.55 | — |
| SECONDARY Tender Joints Count (TJC) |
23.64; NA; 22.79; NA; 21.46; 24.84 | — |
| SECONDARY Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-4.68; NA; -5.09; NA; -6.06; -7.62 | — |
| SECONDARY Swollen Joints Count (SJC) |
16.51; NA; 15.68; NA; 14.06; 14.74 | — |
| SECONDARY Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-3.43; NA; -4.71; NA; -4.24; -4.75 | — |
| SECONDARY Patient Assessment of Arthritis Pain |
59.96; NA; 55.05; NA; 54.87; 56.66 | — |
| SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-9.49; NA; -11.00; NA; -10.76; -15.30 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis |
62.47; NA; 58.91; NA; 54.62; 58.35 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-8.57; NA; -16.96; NA; -12.37; -16.74 | — |
| SECONDARY Physician Global Assessment of Arthritis |
62.66; NA; 57.50; NA; 56.51; 60.77 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-12.88; NA; -16.43; NA; -14.60; -17.88 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.58; NA; 1.36; NA; 1.44; 1.33 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-0.15; NA; -0.23; NA; -0.23; -0.18 | — |
| SECONDARY C-Reactive Protein (CRP) |
16.30; NA; 15.85; NA; 18.03; 14.42 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-2.05; NA; -6.93; NA; -11.38; -9.19 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
5.48; NA; 5.31; NA; 5.14; 5.28 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET |
-0.55; NA; -0.78; NA; -0.86; -1.07 | — |
| SECONDARY Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) |
4.7; NA; 4.8; NA; 9.5; 13.0 | — |
| SECONDARY Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) |
1.56; NA; 3.17; NA; 1.59; 4.41 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
31.48; NA; 33.20; NA; 31.93; 31.92 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET |
3.98; NA; 3.39; NA; 4.57; 4.18 | — |
| SECONDARY Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score |
0.45; NA; 0.46; NA; 0.50; 0.48 | — |
| SECONDARY Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET |
0.15; NA; 0.16; NA; 0.11; 0.17 | — |
| SECONDARY Medical Outcome Study- Sleep Scale (MOS-SS) |
40.62; NA; 44.46; NA; 38.12; 36.94 | — |
| SECONDARY Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET |
-0.95; NA; -6.57; NA; -3.43; -2.05 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale |
28.17; NA; 29.92; NA; 28.76; 30.06 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET |
1.96; NA; 2.74; NA; 3.54; 2.80 | — |
Eligibility Criteria
Inclusion Criteria
- Active rheumatoid arthritis
- Inadequate response to stably dosed methotrexate
Exclusion Criteria
- Current therapy with any DMARD or biologic other than methotrexate
Data sourced from ClinicalTrials.gov (NCT00413660). 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.