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
  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:


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
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, see Learn About Clinical Studies.

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:
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 July 24, 2014