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
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 ClinicalTrials.gov identifier: NCT00550355

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Peoria, Arizona, United States, 85381
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Port Orange, Florida, United States, 32127
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Michigan
Pfizer Investigational Site
Lansing, Michigan, United States, 48910-8595
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1013AAR
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Sofia, Bulgaria, 1612
Pfizer Investigational Site
Sofia, Bulgaria, 1606
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Praha 4, Czech Republic, 140 59
Mexico
Pfizer Investigational Site
Mexico, D.f., Mexico, 06700
Pfizer Investigational Site
Mexico, DF, Mexico, 14050
Poland
Pfizer Investigational Site
Bialystok, Poland, 15-461
Pfizer Investigational Site
Bialystok, Poland, 15-875
Pfizer Investigational Site
Krakow, Poland, 31-752
Pfizer Investigational Site
Krakow, Poland, 31-201
Pfizer Investigational Site
Warszawa, Poland, 02-637
Pfizer Investigational Site
Wroclaw, Poland, 51-124
Slovakia
Pfizer Investigational Site
Piestany, Slovakia, 921 01
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15705
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 August 27, 2014