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

NCT00383188

Last updated date
Study Location
Pfizer Investigational Site
Malvern East, Victoria, 3145, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
305
Original Enrollment  ICMJE
 (submitted: September 28, 2006)
290
Actual Study Completion Date  ICMJE July 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Chile,   Czech Republic,   Estonia,   India,   Korea, Republic of,   Peru,   Poland,   Russian Federation,   South Africa,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383188
Other Study ID Numbers  ICMJE A6631007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

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