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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: Clinical Trial Phase 3 study, sponsored by Genentech.
NCT00476996 is a Phase 3 study that was terminated before completion, run by Genentech. The registered enrollment target is 836 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \[VAS\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
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 |
Why NCT00476996 stopped before completion
NCT00476996 is an interventional study that assigns participants to a tested intervention. The registered 836 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00476996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00476996's enrollment target sits among peer trials
836 396th of 2000 higher than 1,604 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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