Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: RITUXIMAB
Sponsors
Dept of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study if all of the following criteria apply: • Between the age of 18 and 65 years of age • Progressive MS since at least three years • Some kind of documented progression of neurological symptoms during the previ-ous two years. • EDSS 4,0 - 7.0 (inclusive) (basically spared arm functions) • Conventional therapy not indicated, contraindicated or failed • Judged as compliant with the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria ap-plies: • Eligible for any of the conventional MS therapies • RRMS • Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture • Cognitive defect making informed consent unreliable • Any medidal condition contraindicating minor surgical procedures, as judged by anaesthesiologist • Severe uncontrolled heart disease • Pregnant or lactating women • Patients having contraindication for or otherwise not compliant with MRI investigations • Documented vulnerability to infections • Simultaneous treatment with other immunosuppressive drugs • Documented allergy or intolerance to Rituximab • Severe psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate tolerability and efficacy of intrathecally administered Mabthera in severe progressive MS where there is no available effective treatment;Secondary Objective: Investigate the effects on immune parameters and magnetic resonance imaging of the treatment;Primary end point(s): The primary endpoint is to document safety parameters during the study The secondary endpoints are clinical variables, ie stabilization of the disease, measured as tes for both leg, arm and cognitiv functions another secondary and exploratory endpoint is by analysing biomarkers and lymfocyte subsets in the CSF and blood to document expected biological effects of the treatment. | — |
Countries
Sweden
Outcome results
None listed