A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Health Condition 1: null- Arthritis, Rheumatoid

• Registration Number: CTRI/2009/091/000596
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

a. Ages Eligible for Study:18 Years and older,

b. Genders Eligible for Study:Both,

c. Accepts Healthy Volunteers:No,

1. The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.

2. The patient has active disease at both Screening and Baseline, as defined by both greaterthan equal to 6 joints tender or painful on motion; and greaterthan equal to 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) greaterthan equal to 28 mm in the local laboratory. 2. CRP greaterthan 7 mg/L in the central laboratory

3. Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.

4. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

5. Patient has washed out of all DMARDs other that antimalarials

There is no upper age limit for inclusion criteria for this trial

Exclusion Criteria

-Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3.
Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
-History of any other autoimmune rheumatic disease other than Sjogren's syndrome
-No malignancy or history of malignancy.
?History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified