Phase 2
Completed N=140
Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00603512 ↗
Enrolled (actual)
140
Serious AEs
3.7%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 64.3; 77.8; 96.3; 80.8 Percentage of Participants
Summary
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment 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 |
64.3; 77.8; 96.3; 80.8; 14.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
28.57; 14.81; 29.63; 38.46; 3.57; 32.14 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
7.14; 3.70; 0.00; 7.69; 0.00; 7.14 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
0.00; 0.00; 0.00; 3.85; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Tender Joint Count (TJC) |
16.36; 16.22; 17.81; 15.42; 16.36; 11.89 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT |
-4.46; -4.19; -4.59; -4.46; -3.50; -4.70 | — |
| SECONDARY Swollen Joint Count (SJC) |
13.18; 15.11; 15.59; 15.12; 13.82; 10.07 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT |
-3.11; -2.54; -2.89; -5.38; -0.64; -4.74 | — |
| SECONDARY Patient Assessment of Arthritis Pain |
54.18; 57.59; 53.22; 52.19; 53.32; 45.36 | — |
| SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT |
-8.82; -14.35; -13.04; -15.12; -3.96; -10.41 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis |
58.00; 60.26; 58.67; 52.04; 53.50; 45.89 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT |
-12.11; -16.92; -16.11; -17.31; -6.96; -12.19 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis |
66.00; 61.44; 59.37; 59.04; 59.39; 49.96 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT |
-16.04; -14.12; -14.11; -22.92; -8.75; -22.33 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.14; 1.29; 1.17; 1.16; 1.25; 1.05 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT |
-0.08; -0.11; -0.12; -0.31; -0.00; -0.13 | — |
| SECONDARY C-Reactive Protein (CRP) |
26.71; 27.63; 16.59; 20.03; 22.25; 15.45 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT |
-11.26; -15.37; -12.07; -16.75; -1.62; -11.83 | — |
| SECONDARY Numeric Index of American College of Rheumatology Response (ACR-n) |
4.80; 6.06; 10.60; 10.73; -11.08; 8.74 | — |
| SECONDARY Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve |
1708.31; 2096.79; 3685.71; 3124.40; -1346.24 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
5.03; 5.13; 5.00; 4.94; 4.90; 4.30 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
6.11; 6.06; 6.02; 5.86; 5.86; 5.42 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
37.87; 37.94; 38.87; 40.93; 38.69; 39.27 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score |
0.55; 0.45; 0.58; 0.55; 0.51; 0.65 | — |
| SECONDARY Medical Outcome Study- Sleep Scale (MOS-SS) |
27.38; 27.41; 29.38; 30.51; 23.93; 28.00 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale |
34.25; 33.37; 34.48; 36.85; 37.07; 36.78 | — |
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 (NCT00603512). 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.