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An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

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.
ClinicalTrials.gov Identifier: NCT00383188
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis
Study Start Date : December 2006
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
Capsule, once daily (QD) for 12 weeks
Experimental: 2 Drug: PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
Experimental: 3 Drug: PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
Experimental: 4 Drug: PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
Experimental: 5 Drug: PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Is PH-797804, a p38 inhibitor, safe and tolerated as a monotherapy agent for 12 weeks in subjects with RA and who have failed at least 1 DMARD [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Is PH-797804, a p38 inhibitor, efficacious in the selected dose range with additional characterization by PK in a 12-week treatment period in subjects with RA and who have failed at least 1 DMARD [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed with RA and has failed at least 1 DMARD therapy

Exclusion Criteria:

  • Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00383188


  Show 48 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00383188     History of Changes
Other Study ID Numbers: A6631007
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
Arthritis, Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases