Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis

Phase 1

• Conditions: 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: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2008-002626-11-SE
• Lead Sponsor: Dept of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-24
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>The secondary endpoints are clinical variables, ie stabilization of the disease, measured as tes for both leg, arm and cognitiv functions<br>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.<br>