A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

November 6, 2018 updated by: Pfizer

A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate

The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Pfizer Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult with RA for at least 6 months
  • Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion Criteria:

  • Severe, progressive and/or uncontrolled other disease
  • Chronic or recent serious infection; current infection
  • Concomitant use of RA therapy other than methotrexate with some exceptions

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: PH-797804
Tablet, 1 mg PH-797804, once daily for 4 weeks
Drug: PH-797804
Tablet, 5 mg PH-797804, once daily for 4 weeks
Placebo Comparator: 1
Drug: Placebo
Tablet, once daily for 4 weeks
Experimental: 3
Drug: PH-797804
Tablet, 1 mg PH-797804, once daily for 4 weeks
Drug: PH-797804
Tablet, 5 mg PH-797804, once daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX
Time Frame: 6 weeks
6 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

March 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6631005

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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