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)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Disease-modifying antirheumatic drug; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039688

A3921069

2009-016987-34 (EudraCT Number)

Details and patient eligibility

About

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Enrollment: 956 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
• Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
• Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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956 participants in 3 patient groups

5 mg BID CP-690,550

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

10 mg BID CP-690,550

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

methotrexate

Active Comparator group

Treatment:

Drug: Disease-modifying antirheumatic drug