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NCT00406419 · ClinicalTrials.gov registry record · Phase 3
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
A Phase 3 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,015
- Enrollment target
NCT00406419 is a Phase 3 study that was terminated before completion, run by Genentech. The registered enrollment target is 1,015 participants.
The verdict
NCT00406419, a Phase 3 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,015 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,015 participants |
| Start Date | 2006-12-27 |
| Est. Completion | 2015-04-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00406419
The ClinicalTrials.gov registry entry for NCT00406419 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,015 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00406419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00406419 about?
NCT00406419 is a clinical study titled "A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)". This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab ...
What is the current status of trial NCT00406419?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,015 participants. The study started on 2006-12-27. Estimated completion is 2015-04-22.
What interventions are being tested in trial NCT00406419?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT00406419?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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