Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00383188
First received: September 28, 2006
Last updated: October 7, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: placebo
Drug: PH-797804
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: December 2006
Study Completion Date: July 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383188

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00383188     History of Changes
Other Study ID Numbers: A6631007
Study First Received: September 28, 2006
Last Updated: October 7, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013