Cladribine Safety Registry
Research type
Research Study
Full title
Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials
IRAS ID
75276
Sponsor organisation
Merck Serono SA-Geneva
Eudract number
2009‐017978‐21
Clinicaltrials.gov Identifier
Research summary
Cladribine Safety Registry.Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). The exact cause of MS is unknown, although it is currently believed to be an autoimmune disorder (body's immune system attacks its own cells). Cladribine is an investigational treatment for patients with multiple sclerosis and is currently the subject of a number of clinical trials that are taking place in the UK and globally. Additional long term safety data for Cladribine is required to gain a better understanding of the safety risks and the overall risk-benefit profile of Cladribine. The main purpose of this registry is to collect long term safety data from subjects who have previously participated in selected clinical trials with Cladribine. Enrollment in to the registry will start after subjects have completed or discontinued previous participation in selected clinical trials. The duration of follow-up for all subjects will extend up to the end of the registry, which is planned for 2018, or 8 years after the subject was enrolled into the first cladribine clinical trial (first visit), whichever occurs first. During the first 2 years of the registry, each enrolled subject will be interviewed every 3 months at the time of routine visits or will be contacted by telephone. Thereafter, the contacts will occur every 6 months until the end of follow-up.The registry is being sponsored by Merck Serono and will be conducted in several countries worldwide including North and South America, Europe, Africa, and Asian-Pacific regions. It is estimated that approximately 500 sites will participate in the registry. ClinicalTrials.gov Identifier: NCT01013350.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
11/YH/0142
Date of REC Opinion
3 Jun 2011
REC opinion
Further Information Favourable Opinion