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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 78
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
Experimental: 2 Drug: PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
Experimental: 3 Drug: PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
Placebo Comparator: 4 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

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00550355     History of Changes
Other Study ID Numbers: A6261002
Study First Received: October 25, 2007
Last Updated: July 13, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014