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Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Salvador, Bahia, 40050-410 Brazil
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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the
1987 American College of Rheumatology (ACR) Revised criteria for RA.

2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of
≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks
immediately prior to screening.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Subjects who used any of the following systemic treatments during the washout periods
given below:

1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in
dose within 28 days of baseline.

2. Treatment with more than 1 NSAID within 14 days at baseline.

3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate
within 28 days of baseline.

4. Subjects will be allowed to continue the following non biologic DMARDs:
sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs
(including but not limited to gold, penicillamine, azathioprine,
cyclophospamide), and biologic DMARDs must have been discontinued at least 2
months prior to Week 1.

5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.

2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

NCT01578850
Pfizer
Completed
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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