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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

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: NCT00620685
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : November 8, 2018
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Placebo Drug: PH-797804 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Tablet, once daily for 4 weeks

Experimental: 2 Drug: PH-797804
Tablet, 1 mg PH-797804, once daily for 4 weeks

Experimental: 3 Drug: PH-797804
Tablet, 5 mg PH-797804, once daily for 4 weeks

Primary Outcome Measures :
  1. Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00620685

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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Colorado
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Michigan
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00620685    
Other Study ID Numbers: A6631005
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by Pfizer:
Arthritis, rheumatoid
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases