A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

Pfizer1 site in 1 country140 target enrollmentJanuary 2008

ConditionsArthritis, Rheumatoid

InterventionsPlacebo CP-690,550

DrugsPlacebo CP-690,550

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Enrollment: 140
Locations: 1
Primary Endpoint: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

September 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

CP-690,550, 0mg

Intervention: Placebo

CP-690,550, 10mg

Intervention: CP-690,550

CP-690,550, 1mg

Intervention: CP-690,550

CP-690,550, 3mg

Intervention: CP-690,550

CP-690,550, 5mg

Intervention: CP-690,550

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

Time Frame: Week 12

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint 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, 8)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 1, 2, 4, 8, 12/End of Treatment (EOT))
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 1, 2, 4, 8, 12/EOT)
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response(Week 1, 2, 4, 8, 12/EOT)
Tender Joint Count (TJC)(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Swollen Joint Count (SJC)(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Patient Assessment of Arthritis Pain(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Physician Global Assessment (PGA) of Arthritis(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
C-Reactive Protein (CRP)(Baseline, Week 1, 2, 4, 8, 12/EOT)
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
Numeric Index of American College of Rheumatology Response (ACR-n)(Week 1, 2, 4, 8, 12/EOT)
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 12)
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 1, 2, 4, 8, 12/EOT)
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Week 1, 2, 4, 8, 12/EOT)
36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12/EOT)
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Baseline, Week 12/EOT)
Medical Outcome Study- Sleep Scale (MOS-SS)(Baseline, Week 2, 12/EOT)
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline, Week 2, 12/EOT)