| 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 |
| |
| 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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| 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 |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| October 2009 |
