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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 374 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00316771
The ClinicalTrials.gov registry entry for NCT00316771 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which P38 Inhibitor (4) 150mg is the first listed.
NCT00316771 reports 0 study locations.
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.
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