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Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381 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
21-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of RA for at least 6 months based upon the American College of Rheumatology
(ACR) 1987 Revised Criteria.

- Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16
weeks immediately prior to enrollment. The dose of methotrexate must be stable for at
least 6 weeks prior to enrollment.

- Females of childbearing potential are required to simultaneously use 2 effective
contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical
cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual
intercourse or willing to use a condom in addition to having their female partner use
another form of contraception, if the woman could become pregnant from the time of the
first dose of study medication until completion of follow up procedures

- Contact your local site for more inclusion criteria.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a
non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis,
fibromyalgia) that, in the investigator's opinion, may interfere with clinical
assessments.

- Evidence of active or latent infection with Mycobacterium tuberculosis (TB).

- Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within
the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or
infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral
corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose
ranges defined in the protocol.

- Contact your local site for more inclusion criteria.

NCT00550355
Pfizer
Completed
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With 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]

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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]

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