Management of the infusion-associated reactions in RRMS patients treated with Lemtrada

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2014-000092-62-BE
• Date of registration: 10/06/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme Corporation
• Public title: Management of the infusion-associated reactions in RRMS patients treated with Lemtrada
• Scientific title: Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD
• Date of first enrolment: 30/07/2014
• Target sample size: 56
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000092-62
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, France, Netherlands, Spain, Switzerland

Contacts

• Name: Brigitte De Witte
• Affiliation: Sanofi Belgium

• Name: Brigitte De Witte
• Affiliation: Sanofi Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
- Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label
- Signed 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 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Previously treated with Lemtrada
- Contraindications to Lemtrada according to the labeling in the country
- Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label
- Currently participating in another investigational interventional study
- Any technical/administrative reason that makes it impossible to enroll the patient in the study
- Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Patient who has withdrawn consent before enrollment (starting from signed informed consent form)
- Despite screening of the patient, enrolment is stopped at the study level
- Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy
- Pregnancy (defined as positive beta-HumanChorionicGonadotropin blood test), breast feeding
- Known infection with latent tuberculosis or active Tuberculosis
- Known infection with Hepatitis B, Hepatitis C


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

Health Condition(s) or Problem(s) studied

Relapsing-remitting multiple sclerosis
MedDRA version: 18.1 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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: up to 30 days in the first treatment course and the second treatment course, respectively

Main Objective: To assess the distribution of IARs by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions

Primary end point(s): Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC).
An IAR is any adverse event occuring during or within 24 hours of Lemtrada infusion.

Proportion of IARs

Proportion and type of serious IARs

Proportion by type (as defined by clinical symptoms)

Secondary Objective:

Secondary ID(s)

LPS13650

Source(s) of Monetary Support

Genzyme Corporation