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 InformationStart Date ICMJE | May 2009 |
---|
Estimated Primary Completion Date | January 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 ICMJE | Same as current |
---|
Change History | Complete 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 InformationBrief Title ICMJE | 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 |
---|
Official Title ICMJE | Phase 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 Phase | Phase III |
---|
Study Type ICMJE | Interventional |
---|
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
---|
Condition ICMJE | Arthritis, 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 InformationEstimated Enrollment ICMJE | 750 |
---|
Estimated Completion Date | February 2011 |
---|
Estimated Primary Completion Date | January 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.
|
---|
Gender | Both |
---|
Ages | 18 Years and older |
---|
Accepts Healthy Volunteers | No |
---|
Contacts ICMJE | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
|
---|
Location Countries ICMJE | United States, Australia, Chile, China, Colombia, Denmark, Finland, Germany, Greece, Malaysia, Mexico, Poland, Russian Federation, Slovakia, Spain, Sweden, Thailand, United Kingdom |
---|
Administrative InformationNCT ID ICMJE | NCT00856544 |
---|
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
---|
Study ID Numbers ICMJE | A3921046 |
---|
Study Sponsor ICMJE | Pfizer |
---|
Collaborators ICMJE | |
---|
Investigators ICMJE | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
|
---|
Information Provided By | Pfizer |
---|
|