The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab

Phase 1

• Conditions: Relapsing-remitting multiple sclerosis; MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000464-42-DE
• Lead Sponsor: Genzyme GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

-A patient with RRMS who has received two courses of alemtuzumab and has an active disease defined by clinical or imaging features.
-Patients with at least 1 relapse within 12 months prior to screening.
-Signed written consent form.

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients who have any of the contraindications noted in the Summary of Product Characteristics (SmPC) of alemtuzumab.
-Patients who received previously more than 2 courses alemtuzumab.
-Patients have received and/or have been receiving any disease modifying MS treatment (excluding corticosteroids) after the second and before the planned additional course of alemtuzumab.
-Patients who received alemtuzumab within less than last 12 months.
-Patients, who are unwilling or unable to complete the questionnaires being used in the study.
-Patients, who are currently participating in an investigational interventional study.

Study & Design

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