Trials / Completed
CompletedNCT00383188
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 19 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2006-12-15
- Primary completion
- 2008-07-01
- Completion
- 2008-07-16
- First posted
- 2006-10-02
- Last updated
- 2021-08-20
- Results posted
- 2021-08-20
Locations
48 sites across 12 countries: Australia, Brazil, Chile, Czechia, Estonia, India, Peru, Poland, Russia, South Africa, South Korea, Spain
Source: ClinicalTrials.gov record NCT00383188. Inclusion in this directory is not an endorsement.