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


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: March 3, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00856544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 2, 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 ]
  • 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 ]
  • Number of days required for a >1 day sequential (2 or more consecutive days) 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: March 3, 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 ]
  • 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 ]

Descriptive Information

Brief Title  ICMJEA 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
Official Title  ICMJEPhase 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
Brief Summary

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.

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
    Film coated tablet, 5 mg po BID, 1 year
  • Drug: CP-690,550
    Film coated tablet, 10 mg po BID, 1 year
  • Drug: Placebo
    Film coated tablet, 1 tablet po BID, 3-6 months
Study Arms / Comparison Groups
  • Active 5 mg: Experimental
    Intervention: Drug: CP-690,550
  • Active 10 mg: Experimental
    Intervention: Drug: CP-690,550
  • Placebo Sequence 1: Placebo Comparator
    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.
    Intervention: Drug: Placebo
  • Placebo Sequence 2: Placebo Comparator
    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.
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE750
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Australia,   Chile,   China,   Colombia,   Denmark,   Finland,   Germany,   Greece,   Malaysia,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00856544
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA3921046
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer