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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

September 28, 2006
October 7, 2009
December 2006
Not Provided
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 ]
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?
Complete list of historical versions of study NCT00383188 on ClinicalTrials.gov Archive Site
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 ]
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?
Not Provided
Not Provided
 
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
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

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: placebo
    Capsule, once daily (QD) for 12 weeks
  • Drug: PH-797804
    Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
  • Drug: PH-797804
    Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
  • Drug: PH-797804
    Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
  • Drug: PH-797804
    Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: PH-797804
  • Experimental: 3
    Intervention: Drug: PH-797804
  • Experimental: 4
    Intervention: Drug: PH-797804
  • Experimental: 5
    Intervention: Drug: PH-797804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
July 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Chile,   Czech Republic,   Estonia,   India,   Korea, Republic of,   Peru,   Poland,   Russian Federation,   South Africa,   Spain
 
NCT00383188
A6631007
No
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP