A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856544

A3921046

Details and patient eligibility

About

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

Enrollment: 795 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
• Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
• Patient must remain on at least one background traditional disease modifying antirheumatic drug.
• No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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795 participants in 4 patient groups, including a placebo group

Active 5 mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Active 10 mg

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Placebo Sequence 1

Placebo Comparator group

Description:

Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.

Treatment:

Drug: Placebo

Drug: Placebo

Placebo Sequence 2

Placebo Comparator group

Description:

Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.

Treatment:

Drug: Placebo

Drug: Placebo