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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00383188

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 II

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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

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 ]

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

Eligibility

Criteria

Inclusion Criteria:

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6631007
Study First Received:	September 28, 2006
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00383188 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Pfizer:

Arthritis, Rheumatoid

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009