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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00550355
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : July 14, 2009
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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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: PD 0360324 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical safety laboratories [ Time Frame: 16 weeks ]
  2. Vital signs [ Time Frame: 16 weeks ]
  3. ECG [ Time Frame: 16 weeks ]
  4. Incidence and severity of adverse events [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic [ Time Frame: 16 weeks ]
  2. Pharmacodynamic [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00550355

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00550355     History of Changes
Other Study ID Numbers: A6261002
First Posted: October 29, 2007    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

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