SAfety and efficacy of VoraxazE for Delayed methotrexate elimination
Research type
Research Study
Full title
A Prospective, Observational, Multi-country, Post-marketing Study on the Safety and Efficacy of Voraxaze (Glucarpidase) in Subjects with Delayed Methotrexate Elimination or at Risk of Methotrexate Toxicity
IRAS ID
336885
Contact name
Dan Stark
Contact email
Sponsor organisation
Protherics Medicines Development Limited (a SERB Specialty Pharmaceuticals Company)
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
Glucarpidase (marketed as Voraxaze by SERB Specialty Pharmaceuticals) has been approved by the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for reducing high methotrexate levels in the blood in adults and children (aged 28 days and older). It is given to people who cannot get rid of the methotrexate from their bodies fast enough or who are at risk of serious side effects after being given methotrexate. The EMA and MHRA are is an agency that makes sure medicines that are given to patients work and are safe.
The purpose of this clinical research study is to continue to learn more about the use of glucarpidase for the treatment of adults and children whose bodies are not getting rid of methotrexate fast enough, or who are at risk of serious side effects after being given methotrexate. This will be done by seeing what happens when a doctor treats a participant as usual, and collecting their data from your medical records.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0199
Date of REC Opinion
3 Sep 2024
REC opinion
Further Information Favourable Opinion