A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Tracking InformationStart Date ICMJE | February 2009 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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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 ]
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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 ]
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Change History | Complete list of historical versions of study NCT00814307 on ClinicalTrials.gov Archive Site |
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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 ]
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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 ]
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Descriptive InformationBrief Title ICMJE | A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis |
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Official Title ICMJE | 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 |
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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. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Arthritis, Rheumatoid |
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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
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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
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Recruitment InformationEstimated Enrollment ICMJE | 500 |
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Estimated Completion Date | November 2010 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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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
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
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Location Countries ICMJE | United States, Brazil, Bulgaria, Chile, Colombia, Czech Republic, Dominican Republic, Germany, India, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Russian Federation, Ukraine |
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Administrative InformationNCT ID ICMJE | NCT00814307 |
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
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Study ID Numbers ICMJE | A3921045 |
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Study Sponsor ICMJE | Pfizer |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
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Information Provided By | Pfizer |
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