Reduce the number of natalizumab infusions in patients with multiple sclerosis

Phase 1

• Conditions: multiple sclerosis; MedDRA version: 18.1Level: LLTClassification code 10070425Term: Multiple sclerosis exacerbationSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000345-31-NL
• Lead Sponsor: VU medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- 18 years or older.
- Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010.
- Natalizumab treatment for 6 months or longer at inclusion.
- An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
- Natalizumab level of >10 µg/ml at least 24 weeks after the initiation of natalizumab or later (4 weeks after last dose, 2 consecutive months).
- Written informed consent.

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Any MS disease activity (radiologically or clinically) during natalizumab treatment, with exclusion of the first three months of treatment.
- Unable to undergo frequent MRI.
- The use of other immunomodulatory medication other than natalizumab.

Study & Design

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