Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis
(MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70%
of treated patients show an incomplete response, including 10 - 30% who are unresponsive.
Corticosteroids and other immunosuppressive therapies presented also many side effects. We
propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest
of rituximab in the treatment of patients with primary IM associated with specific AAb
(anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional
therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP
AAbs), and 12 with MG will be included in the study.
Phase:
Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France Roche Pharma AG