Status:
COMPLETED
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy a...
Eligibility Criteria
Inclusion
- The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient must have had an inadequate response to methotrexate and have active disease, 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.
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Exclusion
- Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/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
- Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
- Patients who have previously received adalimumab therapy for any reason.
- Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
- Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
717 Patients enrolled
Trial Details
Trial ID
NCT00853385
Start Date
May 1 2009
End Date
March 1 2011
Last Update
January 18 2013
Active Locations (125)
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1
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
2
Pfizer Investigational Site
Glendale, Arizona, United States, 85304
3
Pfizer Investigational Site
Mesa, Arizona, United States, 85202
4
Pfizer Investigational Site
Paradise Valley, Arizona, United States, 85253