A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis

Pfizer1 site in 1 country264 target enrollmentJanuary 2005

ConditionsRheumatoid Arthritis

InterventionsCP-690,550 Placebo

DrugsCP-690,550

Overview

Phase: Phase 2
Intervention: CP-690,550
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Enrollment: 264
Locations: 1
Primary Endpoint: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

June 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

5 mg BID

CP 690,550 5 mg BID

Intervention: CP-690,550

15 mg BID

CP 690,550 15 mg BID

Intervention: CP-690,550

30 mg BID

Oral tablets administered at a dose of 30 mg BID for 6 weeks

Intervention: CP-690,550

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6

Time Frame: Week 6

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Secondary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Week 1, 2, 4, and 8)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 1, 2, 4, 6, and 8)
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 1, 2, 4, 6, and 8)
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 6)
Tender Joints Count (TJC)(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Swollen Joints Count (SJC)(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Physician Global Assessment of Arthritis(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Patient Assessment of Arthritis Pain(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
C-Reactive Protein (CRP)(Baseline, Week 1, 2, 4, 6, and 8)
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 1, 2, 4, 6, and 8)
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(Baseline, Week 1, 2, 4, 6, and 8)
Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)(Baseline, Week 1, 2, 4, 6, and 8)