Personalizing the treatment with natalizumab in patients with multiple sclerosis

Phase 1

• Conditions: Relapsing remitting multiple sclerosis; MedDRA version: 20.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-002566-13-NL
• Lead Sponsor: Amsterdam University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

•Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria20
•6 or more consecutive natalizumab infusions
•18 years or older
•Agreed to participate (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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•High titer natalizumab (>100AU/ml) antibodies
•Contraindication for frequent magnetic resonance imaging (MRI)

•Only in the subgroup researching a lower natalizumab trough concentration of 5µg/ml: any disease activity (radiological or clinical) in the past 12 months prior to inclusion

Study & Design

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