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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 logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Arthritis, Rheumatoid

Treatments

Drug: CP-690,550
Drug: Placebo

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

795 participants in 4 patient groups, including a placebo group

Active 5 mg
Experimental group
Treatment:
Drug: CP-690,550
Active 10 mg
Experimental group
Treatment:
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
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

Trial contacts and locations

133

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Data sourced from clinicaltrials.gov

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