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A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
This study is not yet open for participant recruitment.
Verified by Pfizer, January 2009
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00814307
  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 III

MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
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

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 the Health Assessment Questionnaire (HAQ DI) [ Time Frame: 6 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 ]

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 nonresponders advance to 5mg CP 690,550 BID at Month 3 visit
Drug: Placebo
Placebo responders do not advance at Month 3 but remain on placebo for duration of study (6 months)
Placebo Sequence 2: Placebo Comparator Drug: Placebo
Placebo nonresponders advance to 10mg CP 690,550 BID at Month 3 visit
Drug: Placebo
Placebo responders do not advance at Month 3 but remain on placebo for duration of study (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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814307

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A3921045
Study First Received: December 22, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00814307  
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Arthritis, Rheumatoid, Antirheumatic Agents, Clinical Trial

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009