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NCT00316771 · ClinicalTrials.gov registry record · Phase 2
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 374
- Enrollment target
NCT00316771: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00316771 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 374 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (181% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316771, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 374 participants
- Enrollment target
Study Summary
This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG P38 Inhibitor (4) 150mg
- DRUG P38 Inhibitor (4) 25mg
- DRUG P38 Inhibitor (4) 300mg
- DRUG P38 Inhibitor (4) 50mg
- DRUG P38 Inhibitor (4) 75mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00316771 record still lists
NCT00316771 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (181% higher).
The record links to 0 conditions, and to 5 interventions - of which P38 Inhibitor (4) 150mg is the first listed.
NCT00316771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316771 about?
NCT00316771 is a clinical study titled "A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy". This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will...
What is the current status of trial NCT00316771?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 374 participants. The study started on 2005-11. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00316771?
The interventions under investigation include: P38 Inhibitor (4) 150mg (DRUG), P38 Inhibitor (4) 25mg (DRUG), P38 Inhibitor (4) 300mg (DRUG), P38 Inhibitor (4) 50mg (DRUG), P38 Inhibitor (4) 75mg (DRUG).
Who is sponsoring clinical trial NCT00316771?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316771's enrollment target sits among peer trials
374 118th of 2000 higher than 1,883 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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