Phase 2 Completed N=317 Randomized Quadruple-blind Treatment

Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

Arthritis, Rheumatoid

Source: ClinicalTrials.gov NCT00687193 ↗

Enrolled (actual)

317

Serious AEs

2.8%

Results posted

Dec 2012

Primary outcomePrimary: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 20; 36; 38; 45 participants

Summary

To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	20; 36; 38; 45; 49; 8	—
SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8	10; 18; 18; 35; 29; 3	—
SECONDARY Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response	1; 5; 6; 17; 12; 0	—
SECONDARY Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response	0; 0; 1; 5; 4; 0	—
SECONDARY Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]	-0.56; -1.03; -1.01; -1.65; -1.63; -0.20	—
SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]	-0.52; -0.93; -1.00; -1.66; -1.58; -0.25	—
SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)	-0.10; -0.15; -0.28; -0.39; -0.40; 0.06	—
SECONDARY Change From Baseline in Painful and Tender Joint Counts	-4.14; -5.13; -5.29; -8.48; -7.73; -2.03	—
SECONDARY Change From Baseline in Swollen Joint Count (SJC)	-3.19; -3.85; -2.58; -6.93; -5.95; -1.58	—
SECONDARY Change From Baseline in Patient's Assessment of Pain	-8.63; -16.70; -19.13; -29.03; -26.45; -1.46	—
SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis	-7.66; -15.25; -20.32; -27.06; -26.80; -1.73	—
SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis	-13.97; -15.86; -18.10; -31.59; -25.93; -6.09	—
SECONDARY Change From Baseline in C- Reactive Protein (CRP) (mg/L)	-5.69; -16.61; -17.32; -22.50; -24.95; 1.02	—
SECONDARY Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)	498.47; 1876.4; 2573.0; 3887.4; 3628.9; -2415	—
SECONDARY Change From Baseline in Euro Quality of Life (EQ-5D)	0.10; 0.21; 0.28; 0.33; 0.33; -0.04	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain	2.62; 6.23; 5.83; 9.59; 8.61; -2.53	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain	3.15; 4.42; 6.17; 8.91; 7.77; -0.72	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain	5.94; 7.81; 9.74; 12.58; 13.90; 0.27	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain	2.12; 4.76; 5.37; 7.57; 7.61; 0.16	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain	3.67; 6.11; 6.58; 11.98; 9.49; 3.38	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain	2.22; 4.88; 4.65; 4.56; 7.62; -0.67	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain	3.83; 4.20; 5.64; 7.99; 6.42; -1.50	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain	3.29; 5.02; 8.62; 7.64; 6.27; 0.59	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)	3.27; 6.03; 6.22; 10.25; 10.27; -1.04	—
SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)	3.00; 3.99; 7.09; 6.15; 5.52; 0.15	—

Eligibility Criteria

Inclusion Criteria

Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion Criteria

Current therapy with any DMARD

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00687193). 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.