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NCT00408213 · ClinicalTrials.gov registry record · Phase 3
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT00408213 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 136 participants.
The verdict
NCT00408213, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG Placebo
- DRUG mycophenolate mofetil [CellCept]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00408213
The ClinicalTrials.gov registry entry for NCT00408213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 136 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 2 interventions - of which Placebo is the first listed.
NCT00408213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00408213 about?
NCT00408213 is a clinical study titled "A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.". This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for th...
What is the current status of trial NCT00408213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2004-06. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00408213?
The interventions under investigation include: Placebo (DRUG), mycophenolate mofetil [CellCept] (DRUG).
Who is sponsoring clinical trial NCT00408213?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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