Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
- Diagnosed with RA and has failed at least 1 DMARD therapy
- Any other inflammatory arthritis and any significant history of acute or chronic
infection with immunomodulatory etiology
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 |
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| Study Arms ICMJE |
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| 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 | 305 | |||
| Original Enrollment ICMJE | 290 | |||
| Actual Study Completion Date ICMJE | July 2008 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
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| 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 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
