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

July 13, 2009 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
Experimental: 2
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
Experimental: 3
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
Drug: PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical safety laboratories
Time Frame: 16 weeks
16 weeks
Vital signs
Time Frame: 16 weeks
16 weeks
ECG
Time Frame: 16 weeks
16 weeks
Incidence and severity of adverse events
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic
Time Frame: 16 weeks
16 weeks
Pharmacodynamic
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 29, 2007

Study Record Updates

Last Update Posted (Estimate)

July 14, 2009

Last Update Submitted That Met QC Criteria

July 13, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6261002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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