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Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
This study is currently recruiting participants.
Verified by Pfizer, January 2009
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00550355
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: PD 0360324
Drug: Placebo
Phase I

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Methotrexate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Pharmacokinetic [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: August 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
2: Experimental Drug: PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
3: Experimental Drug: PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
4: Placebo Comparator Drug: Placebo
3 doses of Placebo administered over 12 weeks

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550355

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 25 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A6261002
Study First Received: October 25, 2007
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00550355  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009