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ORAL 1045

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oral 1045

 

A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Purpose

This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe 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 Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

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: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Health Assessment Questionnaire (HAQ DI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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 ]
  • 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 [ Time Frame: Months 1 ,3, 6 nd early termination ] [ 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 subject [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vital signs (blood pressure, heart rate, and oral, temporal or tympanic temperature preferred) measurements [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
  • MOS Sleep scale [ Time Frame: Months 1 ,3,6 and early termination ] [ Designated as safety issue: No ]
  • FACIT Fatigue scale [ Time Frame: Months 1 ,3,6 and early termination ] [ Designated as safety issue: No ]
  • Euro Qol EQ 5D scale [ Time Frame: Months 1 ,3,6 and early termination ] [ Designated as safety issue: No ]
  • RA Healthcare Resource Utilization Questionnaire [ Time Frame: Months 1 ,3,6 and early termination ] [ Designated as safety issue: No ]
  • Work Limitations Questionnaire [ Time Frame: Months 1 ,3,6 and early termination ] [ Designated as safety issue: No ]
  • Number of Days required for a >1 day CONSECUTIVE sequential decrease in: - Patient Assessment of Arthritis Pain; - Patient Global Assessment of Arthritis. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

 

Estimated Enrollment: 500
Study Start Date:
February 2009
Estimated Study Completion Date:
November 2010
Estimated Primary Completion Date:
November 2010 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions
Active 5mg: Experimental

Drug: CP-690,550

5mg CP-690,550 BID PO for 6 months

Active 10 mg: Experimental

Drug: CP-690,550

10 mg CP-690,550 BID PO for 6 months

Placebo Sequence 1: Placebo Comparator

Drug: Placebo

Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit

Placebo Sequence 2: Placebo Comparator

Drug: Placebo

Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit

 

Eligibility

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

 

Criteria

Inclusion Criteria:

    White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L

  • The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory
  • Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • Patient has washed out of all DMARDs other that antimalarials

 

Exclusion Criteria:

  • Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
  • History of any other autoimmune rheumatic 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.