2-year ext. study to evaluate long-term effectiveness of Mavenclad

• Research type

  Research Study

• Full title

  A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS).

• IRAS ID

  289669

• Contact name

  Basil Sharrack

• Contact email

  basil.sharrack@nhs.net

• Sponsor organisation

  Merck Healthcare KGaA

• Eudract number

  2020-003995-42

• Clinicaltrials.gov Identifier

  NCT03364036

• Clinicaltrials.gov Identifier

  2020-003995-42, EudraCT:

• Duration of Study in the UK

  3 years, 0 months, 5 days

• Research summary

  The purpose of this low-interventional clinical study is to evaluate the long-term disease activity and to further explore the long-term effect and safety during year 3 and 4 after treatment with Mavenclad (years 1 and 2)in multiple sclerosis (MS) patients who have taken part in the parent study. The drug aims to reduce the treatment burden for patients with MS. The study will run for 2 years (rolling on from the parent study) at UK hospitals and patients are expected to have a visit the hospital 3 times during the course of the study (baseline, after 1 year, and after 2 years). Patients will have an MRI at visit 1 and 2 and blood samples taken at baseline, visit 1 and 2 as well as various neurological tests and physical examinations. Only patients that are on the parent study will be eligible to join this extension study.
  URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04783935%253Fid%253DNCT04783935%2526rank%253D1%2FNBTI%2FbOq4AQ%2FAQ%2F0c67cfa9-d00e-4540-820c-3e93947a3087%2F2%2FidJncDSYZx&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C6fb79cab01384b5ba3d208dcf4f95bff%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638654599025508197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=dXEXNVeOBbVR%2FLAVRO4bl3m6XklnZmcuCpjuZHw%2FmXs%3D&reserved=0

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  20/EM/0300

• Date of REC Opinion

  22 Feb 2021

• REC opinion

  Further Information Favourable Opinion