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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2016-000464-42-DE
• Date of registration: 11/04/2016
• Prospective Registration: Yes
• Primary sponsor: Genzyme GmbH
• Public title: The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab
• Scientific title: A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse
• Date of first enrolment: 13/06/2016
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000464-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Affiliation: Sanofi-Aventis Deutschland GmbH

• Affiliation: Sanofi-Aventis Deutschland GmbH

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Other descriptive name: ALEMTUZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: Evaluation of effectiveness of an additional alemtuzumab course in patients with relapsing remitting multiple sclerosis (RRMS) with disease activity after 2 courses.

Secondary Objective: -To assess changes over time in:
-Expanded Disability Status Scale (EDSS) scores,
-Magnetic resonance imaging (MRI) lesions (Gd and T2 lesions),
-Symbol Digit Modalities Test (SDMT),
-Patient Reported Indices for Multiple Sclerosis (PRIMUS),
-Euro Quality of Life (EuroQoL, EQ-5D) score,
-Work Productivity and Activity Impairment (WPAI) at each visit compared to baseline score.
-To describe the safety and tolerability of alemtuzumab after an additional treatment course.

Primary end point(s): - Change in neurological examination (Confirmed relapse[s])
- Changes from baseline in EDDS score (increase of at least 1 point)

Timepoint(s) of evaluation of this end point: add 1: Visit V3 (Month 6) and V4 (Month 12 – End Of Study)
add 2: 12 months following the 3 Day course of alemtuzumab

Secondary Outcome(s)

Secondary end point(s): 1. Percentage of relapse-free participants
2. Percentage of participants with active MRI lesions
3. Change in number of active MRI lesions (Gd and T2 lesions)
4. Change over time in Expanded Disability Status Scale (EDSS)
5. Change over time in Symbol Digit Modality Test (SDMT)
6. Change over time in Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS)
7. Change over time in Euro Quality of Life (EQ-5D)
8. Change over time in Work Productivity and Activity Impairement Questionnaire (WPAI)
9. Number of participants with adverse events

Timepoint(s) of evaluation of this end point: 1-3: V4 (Month 12 – End Of Study)
4-8: Visit V3 (Month 6) and V4 (Month 12 – End Of Study)
9: Up to Month 12 (V4)

Secondary ID(s)

ALEMLL08091

Source(s) of Monetary Support

Genzyme GmbH

Ethics review

Status: Approved
Approval date:
Contact: