Status:
COMPLETED
Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Roche Pharma AG
Conditions:
Myositis
Myasthenia Gravis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 pat...
Detailed Description
Rituximab, a chimeric monoclonal antibody specific for human CD20, which targets B lymphocytes, has been first developed as biotherapy for the treatment of B lymphoma. In this context, hundred thousan...
Eligibility Criteria
Inclusion
- For myositis III. Idiopathic myositis
- Myositis as defined by the 119th ENMC:
- Proximal myopathy with weakness
- Subacute or insidious onset over 18 years
- Myogenic syndrome on EMG (optional)
- Muscle fibre necrosis and regeneration and/or inflammatory cell infiltrate on muscular biopsy
- Specific AAbs : anti-synthetases (anti-JO1, anti-PL7, or anti-PL12), or anti-SRP.
- IV. Refractory to the conventional treatments Resistance to conventional treatments is defined as an inadequate response to, or intolerable side effects with conventional treatments, such as corticosteroids, azathioprine, methotrexate, cyclophosphamide, cyclosporine, IgIV and/or plasma exchange. At least one or more of these drugs or therapeutical approaches (used alone or as a combination) must have been unsuccessfully tested before inclusion. Inadequate response is defined as the lack of improvement and/or the degradation of evaluation parameters (defined bellow) despite these conventional therapies, that led to a modification or a reintroduction of treatment.
- For myasthenia III. Generalised MG
- Generalised seropositive MG as defined by the Texas Clinical Classification System:
- Extraocular muscle weakness quantified with MG muscle score (MMS), whose inter and inter observer reproducibility has been demonstrated \[44\].
- Specific AAbs : anti-AchR IV. Refractory to the conventional treatments Resistance to conventional treatments is defined as an inadequate response to, or intolerable side effects with conventional treatments, such as corticosteroids, azathioprine, methotrexate, cyclophosphamide, cyclosporine, IgIV and/or plasma exchange. At least one or more of these drugs or therapeutical approaches (used alone or as a combination) must have been unsuccessfully tested before inclusion. Inadequate response is defined as the lack of improvement and/or the degradation of evaluation parameters (defined bellow) despite these conventional therapies, that led to a modification or a reintroduction of treatment
Exclusion
- Other muscular diseases, such as:
- Inclusion body myositis
- Macrophagic myofasciitis
- Inherited myopathies
- Secondary IM to one other connective tissue disorders
- Systemic scleroderma (ARA and/or "LEROY AND MEDSGER" criteria)
- Sjögren's syndrome (European criteria)
- Systemic lupus erythematosus (ACR criteria)
- Rheumatoid arthritis (ACR criteria)
- Mixed connective tissue disease (ACR criteria)
- Other myasthenic syndrome, such as:
- Non generalised, ocular MG
- Lambert Eaton syndrome
- MG associated with malignant thymoma
- Inherited myasthenic syndrome
- Cancer (or cancer-associated myositis)
- Age \< 18 years
- Pregnancy
- HIV seropositivity
- Evolutive infection (B, C hepatitis, tuberculosis)
- Lack of approved consent
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00774462
Start Date
January 1 2008
End Date
December 1 2011
Last Update
December 11 2012
Active Locations (1)
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1
Service de Médecine Interne 1 / Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75651 Cedex 13