Find out if you qualify for one of the ORAL trials. Call
800-718-1021.

Know someone with RA? Send a link to tell them about the ORAL trials. Email a friend.

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.

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)

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