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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: Clinical Trial Phase 3 study, sponsored by Genentech.
NCT00406419 is a Phase 3 study that was terminated before completion, run by Genentech. The registered enrollment target is 1,015 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ACR20 is defined as 20 percent improvement respectively in: a) swollen joint count (SJC) and tender joint count (TJC) and b) Three of the following 5 assessments: Subject's global assessment of pain by VAS Subject's global assessment of disease activity (VAS) Investigator/Physician's global assessment of disease activity (VAS) Subject's assessment of disability measured by HAQ-DI Acute phase reactant (ESR or CRP).
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 |
Why NCT00406419 stopped before completion
NCT00406419 is an interventional study that assigns participants to a tested intervention. Its 1,015 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00406419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00406419's enrollment target sits among peer trials
1,015 294th of 2000 higher than 1,707 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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