Effect of rituximab in secondary progressive multiple sclerosis

A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004436-36-DK

Enrollment

Registered

2013-04-22

Start date

2013-04-19

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: MabThera (Rituximab) Product Name: MabThera Pharmaceutical Form: Injection INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Denmark

Contacts

Public ContactMads Ravnborg

Odense University Hospital

4565412475

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026