Clinical Trials/NCT00413660

NCT00413660

Completed

Phase 2

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

Pfizer1 site in 1 country509 target enrollmentJanuary 2007

ConditionsArthritis, Rheumatoid

InterventionsCP-690,550 placebo

DrugsCP-690,550

Overview

Phase: Phase 2
Intervention: CP-690,550
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Enrollment: 509
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 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

August 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 5 mg BID

Intervention: CP-690,550

CP 690,550 1 mg BID

Intervention: CP-690,550

CP 690,550 10 mg BID

Intervention: CP-690,550

CP 690,550 15 mg

Intervention: CP-690,550

CP 690,550 3 mg BID

Intervention: CP-690,550

CP-690,550 20 mg QD

Intervention: CP-690,550

Placebo

Dummy tablets

Intervention: placebo

Outcomes

Primary Outcomes

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

Time Frame: Week 12

ACR20 response: \>= 20% 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 2, 4, 6, 8, 16, 20, 24/Early Termination (ET))
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 2, 4, 6, 8, 12)
Tender Joints Count (TJC)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Swollen Joints Count (SJC)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Patient Assessment of Arthritis Pain(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Physician Global Assessment of Arthritis(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
C-Reactive Protein (CRP)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
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(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12, 24/ET)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET(Baseline, Week 12, 24/ET)
Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score(Baseline, Week 12, 24/ET)
Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET(Baseline, Week 12, 24/ET)
Medical Outcome Study- Sleep Scale (MOS-SS)(Baseline, Week 2, 12, 24/ET)
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET(Baseline, Week 2, 12, 24/ET)
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline, Week 2, 12, 24/ET)
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET(Baseline, Week 2, 12, 24/ET)