Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT00774462
Phase
PHASE2
Status
Completed

Conditions

  • Myasthenia Gravis
  • Myositis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 1000 mg intravenous, 2 times, 2 weeks apart and 1000 mg 6 months after the last injection

Study Details

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.

Key Dates

Start date
Jan 31, 2008
Status verified
Dec 2007
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Score of muscular strength (Kendall's muscular testing for myositis or MG muscular score for myasthenia) [ Time Frame: at month 12 ]

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