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

Roche

Status and phase: Completed; Phase 3

Conditions: Myasthenia Gravis Generalised

Treatments: Drug: mycophenolate mofetil [CellCept]; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408213

WX18411

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: mycophenolate mofetil [CellCept]

2

Placebo Comparator group

Treatment:

Drug: Placebo