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ORAL 1046

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oral 1045

 

A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for the Treatment of Rheumatoid Arthritis in Patients on Other Background Arthritis Medications

Purpose

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.

Condition

Intervention

Phase

Arthritis, Rheumatoid Drug: CP-690,550
Drug: Placebo
Phase 3

 

Study Type: Interventional

Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

  • American College of Rheumatology 20 (ACR20) responder rate versus placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in health assessment questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of CP 690,550 versus placebo in patients with active rheumatoid arthritis on background traditional disease modifying anti-rheumatic drugs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Incidence and severity of adverse events [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
  • ACR20 responder rates [ Time Frame: All time points ] [ Designated as safety issue: No ]
  • ACR50 responder rates [ Time Frame: All time points ] [ Designated as safety issue: No ]
  • ACR70 responder rates [ Time Frame: All time points ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS) 28 [ Time Frame: All time points ] [ Designated as safety issue: No ]
  • HAQ-DI [ Time Frame: All time points ] [ Designated as safety issue: No ]
  • SF 36 (Version 2, Acute) [ Time Frame: Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • MOS Sleep Scale [ Time Frame: Months 1, 3, 6, and 12 ] [ Designated as safety issue: No ]
  • FACIT - Fatigue Scale [ Time Frame: Months 1, 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Euro Qol EQ 5D [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • RA Healthcare Resource Utilization Questionnaire [ Time Frame: Months 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
  • Summary of changes in physical examination compared to baseline by patient [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vital signs (blood pressure, heart rate, and temperature) measurements [ Time Frame: All time points ] [ Designated as safety issue: Yes ]

 

Estimated Enrollment: 750
Study Start Date:
May 2009
Estimated Study Completion Date:
February 2011
Estimated Primary Completion Date:
February 2011 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions
Active 5mg: Experimental

Drug: CP-690,550

Film coated tablet, 5 mg po BID, 1 year

Active 10 mg: Experimental

Drug: CP-690,550

Film coated tablet, 10 mg po BID, 1 year

Placebo Sequence 1: 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.

Drug: Placebo

Film coated tablet, 1 tablet po BID, 3-6 months

Placebo Sequence 2: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.

Drug: Placebo

Film coated tablet, 1 tablet po BID, 3-6 months

 

Eligibility

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

 

Criteria

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.

 

This information is also available at www.clinicaltrials.gov Last updated September 29, 2009.