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


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 23, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: December 22, 2008)
  • American College of Rheumatology 20 (ACR20) responder rate versus placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Health Assessment Questionnaire (HAQ DI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00814307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 23, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: December 22, 2008)
  • 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 ]

Descriptive Information

Brief Title  ICMJEA Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Official Title  ICMJEPhase 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEArthritis, Rheumatoid
Intervention  ICMJE
  • Drug: CP-690,550
    5mg CP-690,550 BID PO for 6 months
  • Drug: CP-690,550
    10 mg CP-690,550 BID PO for 6 months
  • Drug: Placebo
    Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
  • Drug: Placebo
    Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Study Arms / Comparison Groups
  • Active 5mg: Experimental
    Intervention: Drug: CP-690,550
  • Active 10 mg: Experimental
    Intervention: Drug: CP-690,550
  • Placebo Sequence 1: Placebo Comparator
    Intervention: Drug: Placebo
  • Placebo Sequence 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE500
Estimated Completion DateNovember 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Brazil,   Bulgaria,   Chile,   Colombia,   Czech Republic,   Dominican Republic,   Germany,   India,   Malaysia,   Mexico,   Philippines,   Poland,   Puerto Rico,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00814307
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA3921045
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer