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NCT00476996 · ClinicalTrials.gov registry record · Phase 3
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
A Phase 3 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 3
- Development phase
- 836
- Enrollment target
NCT00476996 is a Phase 3 study that was terminated before completion, run by Genentech. The registered enrollment target is 836 participants.
The verdict
NCT00476996, a Phase 3 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 836 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. 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 stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG Leflunomide
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 836 participants |
| Start Date | 2007-05-15 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00476996
The ClinicalTrials.gov registry entry for NCT00476996 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 836 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 4 interventions - of which Placebo is the first listed.
NCT00476996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00476996 about?
NCT00476996 is a clinical study titled "A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)". This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i...
What is the current status of trial NCT00476996?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 836 participants. The study started on 2007-05-15. Estimated completion is 2018-05-14.
What interventions are being tested in trial NCT00476996?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), Leflunomide (DRUG), Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT00476996?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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