Trial record 19 of 30 for:
"Myasthenia gravis"
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00408213
First received: December 5, 2006
Last updated: May 22, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myasthenia Gravis Generalised |
Drug: mycophenolate mofetil [CellCept] Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone |
Resource links provided by NLM:
Genetics Home Reference related topics:
myasthenia gravis
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 136 |
| Study Start Date: | June 2004 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: mycophenolate mofetil [CellCept]
1g po bid
|
| Placebo Comparator: 2 |
Drug: Placebo
po bid
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.
Exclusion Criteria:
- regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
- medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408213
Locations
| United States, Arizona | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Sacramento, California, United States, 95817 | |
| United States, Pennsylvania | |
| Upland, Pennsylvania, United States, 19013 | |
| Former Serbia and Montenegro | |
| Belgrade, Former Serbia and Montenegro, 11000 | |
| France | |
| Bordeaux, France | |
| Nice, France | |
| Germany | |
| München, Germany, 81675 | |
| Regensburg, Germany, 93053 | |
| Italy | |
| Milano, Italy, 20133 | |
| Roma, Italy, 185 | |
| Ukraine | |
| Kharkov, Ukraine, 61068 | |
| Kiev, Ukraine | |
| Zaporozhye, Ukraine | |
| United Kingdom | |
| Liverpool, United Kingdom, L9 1AE | |
| Oxford, United Kingdom, OX2 6HE | |
| Salford, United Kingdom, M6 8HD | |
Sponsors and Collaborators
Hoffmann-La Roche
Aspreva Pharmaceuticals
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00408213 History of Changes |
| Obsolete Identifiers: | NCT00231088 |
| Other Study ID Numbers: | WX18411 |
| Study First Received: | December 5, 2006 |
| Last Updated: | May 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System Nervous System Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Pathologic Processes |
Signs and Symptoms Mycophenolate mofetil Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013