Effect of rituximab in secondary progressive multiple sclerosis

Phase 1

Conditions: Multiple Sclerosis
MedDRA version: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-004436-36-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Clinical definate multiple sclerosis

Secondary progressive multiple sclerosis defines as no relaps within 1 year, and sustained progression more than 3 month

Disease duration >15 years

EDSS score 3-7 (both included)

No contrast enhancement on MRI

Presence of oligoclonal bands and increased intrathechal IgG index
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy and lactation

Positive anti-JC virus antibody

Treatment with Natalizumab within 6 month

Treatment with interferon-beta or glatiramer acetate within 3 month

Prior treatment with immunosupressant

Decreased leucocyte or platelet count

Decreased liver or kidneyfunction

B-cell deficiency (low IgA, IgG or IgM)

Implanted metal or devices that contraindicates MRI

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate the safety of intrathecal administered Rituximab to patients with secondary progressive multiple sclerosis, based upon analysis of the intrathecal and periferal immune response.;Secondary Objective: The secondary objective is to investigate effects of intrathecal administered rituximab on clinical performance, cognition and MRI parameters.;Primary end point(s): Change in spinal fluid immune respons after 1 and 3 month;Timepoint(s) of evaluation of this end point: See E.5.1

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety (Adverse events)<br><br>Changes in the following:<br>1) Spinal fluid immune respons 6 month after first and second treatment<br>2) Systemic immune respons 1,3,6,9,12,15,18,21 and 24 month after treatment<br>3) MRI 2 years after treatment<br>4) Cognition 2 years after treatment<br>5) EDSS and MSIS 12 and 24 months after treatment;Timepoint(s) of evaluation of this end point: See E.5.2