Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL1069)
- Conditions
- Health Condition 1: null- Arthritis, Rheumatoid
- Registration Number
- CTRI/2010/091/001027
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 960
1. Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate or have received less than or equal to 3 doses of MTX, not stopped due to related adverse events.
2.Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
3.Active disease as defined by both greater than equal to 6 tender or painful joints on motion and greater than equal to 6 joints swollen, and either an erythrocyte sedimentation rate (ESR) is greater than 28 mm or a C-reactive protein (CRP) concentration is greater than 7 mg/dL
-Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
-History of any other rheumatic autoimmune 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
-No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method