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

Last updated on October 4, 2018

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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.
Show details

- 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.
Show details

- 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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Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: PD 0360324
    3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
  • Drug: PD 0360324
    3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
  • Drug: PD 0360324
    3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
  • Drug: Placebo
    3 doses of Placebo administered over 12 weeks
  • Experimental: 1
    Intervention: Drug: PD 0360324
  • Experimental: 2
    Intervention: Drug: PD 0360324
  • Experimental: 3
    Intervention: Drug: PD 0360324
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Czech Republic,   Mexico,   Poland,   Slovakia,   Spain,   United States
 
 
NCT00550355
A6261002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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