An observational, Quality of Life study in Lemtrada MS patients
Research type
Research Study
Full title
A prospective, observational study to evaluate quality of life, patient-reported outcomes, and safety in patients with relapsing-remitting multiple sclerosis who are being treated with alemtuzumab (LEMTRADA®)in routine clinical practice
IRAS ID
202691
Contact name
Timothy Harrower
Contact email
Sponsor organisation
Sanofi
Clinicaltrials.gov Identifier
NEUR_30360, NIHR CRN
Duration of Study in the UK
4 years, 11 months, 14 days
Research summary
This is a prospective observational study. The purpose of this study is to evaluate Quality of Life in adult patients with relapsing remitting multiple sclerosis (RRMS) following treatment with LEMTRADA®. This study will collect information for a period of 3 years following the patient’s first dose of LEMTRADA®.
Enrolled patients will receive treatment and evaluations for their Multiple Sclerosis as determined by their treating physicians in accordance with local standard of care. Visits will be scheduled by the treating healthcare provider (HCP) according to patient specific needs and local clinical practice. LEMTRADA® will be prescribed to the patient independent to their participation in the study.
There will be 6 study visits for participating patients. Data collection will be at baseline and at months 3, 6, 12, 24 and 36/end of study (EOS). The patient's baseline visit will be conducted prior to the first infusion of LEMTRADA, with other visits as scheduled by the health care provider, depending on local clinical practice.
After patient consent, demographics, information about the patients disease, related treatment history and information to help to obtain a good understanding of potential side effects after treatment with LEMTRADA® will be recorded. To assess the patients Quality of Life, patients will also be required to complete 6 questionnaires, taking approximately 30 minutes to complete. The questionnaires will assess the patients levels of fatigue, anxiety and depression, cognition, bladder and bowel dysfunction, disability and working capacity/daily activity. This data will be collected at baseline, 3 months, 6 months, 12 months, 24 months and 36 months post enrolment.
The study duration is expected to be approximately 5 years in duration, including an approximate 2 year enrolment period.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0252
Date of REC Opinion
28 Jul 2016
REC opinion
Further Information Favourable Opinion