A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00408213
• Collaborator: Aspreva Pharmaceuticals (Industry)
• Enrollment: 136
• Locations: 16
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis Generalised	Drug: mycophenolate mofetil [CellCept]; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jun 1, 2004
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: mycophenolate mofetil [CellCept]; 1g po bid
Placebo Comparator: 2	Drug: Placebo; po bid

Outcome Measures

Primary Outcome Measures

1. AEs, laboratory parameters, vital signs. [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Sun City	Arizona	United States	85351
2		Sacramento	California	United States	95817
3		Upland	Pennsylvania	United States	19013
4		Belgrade		Former Serbia and Montenegro	11000
5		Bordeaux		France
6		Nice		France
7		München		Germany	81675
8		Regensburg		Germany	93053
9		Milano		Italy	20133
10		Roma		Italy	185
11		Kharkov		Ukraine	61068
12		Kiev		Ukraine
13		Zaporozhye		Ukraine
14		Liverpool		United Kingdom	L9 1AE
15		Oxford		United Kingdom	OX2 6HE
16		Salford		United Kingdom	M6 8HD

Sponsors and Collaborators

• Hoffmann-La Roche
• Aspreva Pharmaceuticals

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00408213
• Other Study ID Numbers: WX18411; NCT00231088
• First Posted: Dec 6, 2006
• Last Update Posted: May 23, 2008
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Myasthenia Gravis; Muscle Weakness; Mycophenolic Acid

Study Results

No Results Posted as of May 23, 2008