A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00683969
• Collaborator: Aspreva Pharmaceuticals (Industry)
• Enrollment: 136
• Locations: 43
• Arms: 2
• Duration (Months): 33
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. 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, Generalized	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 Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis
• Study Start Date: Aug 1, 2004
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: mycophenolate mofetil (CellCept); 1g bid for 36 weeks
Placebo Comparator: 2	Drug: placebo; po bid for 36 weeks

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects reaching responder status [Week 36]

Secondary Outcome Measures

1. Time to start of response [Event driven]

2. Mean and median prednisone dose and cholinesterase inhibitor dose [Week 36]

3. Adverse events, lab 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:

• adult patients 18 to 80 years of age;

• diagnosis of myasthenia gravis;

• history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;

• duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;

• prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.

Exclusion Criteria:

• female patients who are pregnant, breastfeeding, or lactating;

• regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;

• any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Sun City	Arizona	United States
2		Sacramento	California	United States	95817
3		Miami	Florida	United States	33136
4		Kansas City	Kansas	United States	66160-7314
5		Rochester	New York	United States	14607
6		Chapel Hill	North Carolina	United States	27599-7025
7		Columbus	Ohio	United States	43210
8		Upland	Pennsylvania	United States	19013-3395
9		Dallas	Texas	United States	75390
10		Galveston	Texas	United States	77555
11		Edmonton	Alberta	Canada	T6G 2B7
12		London	Ontario	Canada	N6A 5A5
13		Belgrade		Former Serbia and Montenegro	11000
14		Bordeaux Cedex		France
15		Nice		France
16		Düsseldorf		Germany	40225
17		München		Germany	81675
18		Regensburg		Germany	93053
19		Tübingen		Germany	72076
20		Hyderabad		India
21		Mumbai		India
22		New Delhi		India
23		Jerusalem		Israel	12000
24		Milano		Italy	20133
25		Roma		Italy	185
26		San Donato Milanese		Italy	20097
27		Mexico City		Mexico	06700
28		Mexico City		Mexico	06726
29		Mexico City		Mexico	14000
30		Leiden		Netherlands	2300 RC
31		Maastricht		Netherlands	6202 AZ
32		Rotterdam		Netherlands	3015 GD
33		Kazan		Russian Federation
34		Moscow		Russian Federation
35		Nizhniy Novgorad		Russian Federation
36		Barcelona		Spain
37		Madrid		Spain
38		Kharkov		Ukraine	61068
39		Kiev		Ukraine
40		Zaporozhye		Ukraine	69035
41		Liverpool		United Kingdom	L9 1AE
42		Oxford		United Kingdom	OX2 6HE
43		Salford		United Kingdom	M6 8HD

Sponsors and Collaborators

• Hoffmann-La Roche
• Aspreva Pharmaceuticals

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche, 973-235-5000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00683969
• Other Study ID Numbers: WX17798; NCT00090636
• First Posted: May 26, 2008
• Last Update Posted: May 26, 2008
• Last Verified: May 1, 2008

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

Study Results

No Results Posted as of May 26, 2008