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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00550355
First received: October 25, 2007
Last updated: July 13, 2009
Last verified: July 2009

October 25, 2007
July 13, 2009
August 2007
June 2009   (final data collection date for primary outcome measure)
  • Clinical safety laboratories [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • clinical safety laboratories
  • vital signs
  • physical exams
  • Incidence and severity of adverse events
  • ECG in patients receiving PD 0360324 relative to placebo throughout the study
Complete list of historical versions of study NCT00550355 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Multiple dose pharmacokinetic and pharmacodynamic profile of intravenously administered PD 0360324 determined throughout the study
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Czech Republic,   Mexico,   Poland,   Slovakia,   Spain
 
NCT00550355
A6261002
No
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