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

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


Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00550355

  Show 25 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer 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, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 26, 2016