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Trial record 1 of 1 for:    NCT00550355
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Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00550355
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : July 14, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 25, 2007
First Posted Date  ICMJE October 29, 2007
Last Update Posted Date July 14, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
  • Clinical safety laboratories [ Time Frame: 16 weeks ]
  • Vital signs [ Time Frame: 16 weeks ]
  • ECG [ Time Frame: 16 weeks ]
  • Incidence and severity of adverse events [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
  • Incidence and severity of adverse events
  • physical exams
  • Clinical safety laboratories
  • Vital signs
  • ECG in patients receiving PD 0360324 relative to placebo throughout the study
Change History Complete list of historical versions of study NCT00550355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Pharmacokinetic [ Time Frame: 16 weeks ]
  • Pharmacodynamic [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
Multiple dose pharmacokinetic and pharmacodynamic profile of intravenously administered PD 0360324 determined throughout the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: PD 0360324
  • Experimental: 2
    Intervention: Drug: PD 0360324
  • Experimental: 3
    Intervention: Drug: PD 0360324
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2009)
78
Original Enrollment  ICMJE
 (submitted: October 25, 2007)
60
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Czech Republic,   Mexico,   Poland,   Slovakia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00550355
Other Study ID Numbers  ICMJE A6261002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP