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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Blood dyscrasias including confirmed: 1. Hemoglobin White blood cell count Platelet count

- 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

NCT00853385
Pfizer
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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now