DRKS00017497
Recruiting
Phase 2
A multicenter randomized, controlled, double-blinded trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis - Generate-Boost
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- autoimmune encephalitis
- Sponsor
- Friedrich-Schiller-Universität Jena
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosed severe autoimmune encephalitis (mRS \= 3\)
- •auto\-antibodies against neuronal surface proteins in the liquor or serum, proof not older than 4 weeks prior to randomisation
- •pretreatment with Rituximab
- •Age \=18 Jahre
- •signed informed consent
- •women of childbearing potential (up to 2 years after menopause): negative pregnancy test
Exclusion Criteria
- •breast\-feeding
- •acute infiltrative pulmonary disease
- •acute infiltrative pericardial disease
- •malignant tumor and current chemotherapy
- •current participation in another interventional study
- •previous participation in this study
- •known hypersensitivity to an ingredient of the investigational product
- •continued therapy with glucocorticoids / Rituximab during the study (last administration must be prior to the first dose of the investigational product)
Outcomes
Primary Outcomes
Not specified
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A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitisautoimmune encephalitisMedDRA version: 20.0Level: PTClassification code: 10072378Term: Encephalitis autoimmune Class: 100000004852Therapeutic area: Diseases [C] - Immune System Diseases [C20]CTIS2024-514494-21-00Friedrich-Schiller-Universitaet Jena50
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