Biogen 101MS329 - Open-Label, Phase 3b, Natalizumab with MS
Research type
Research Study
Full title
A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
IRAS ID
254760
Contact name
Owen Pearson
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2018-002145-11
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Research Summary
The main purpose of this study is to test how well the study drug, Natalizumab (Tysabri®), works when given every 6 weeks compared with the standard and approved every 4 weeks, in patients with relapsing-remitting multiple sclerosis (RRMS). Increasing the time between each dose of the study drug from 4 weeks to 6 weeks has been practiced by some doctors in anti-John Cunningham (JCV) antibody-positive patients to reduce the risk of them contracting progressive multifocal leukoencephalopathy (a rare viral disease which consists of progressive damage or inflammation to the white matter of the brain), whilst at the same time still being effective at treating their Multiple Sclerosis.
Participants who take part in this study will be randomised into one of two groups. All participants will receive the study drug at the standard approved dose of 300mg, which will be given by an infusion (drip) directly into a vein. Half of participants will receive the study drug every 4 weeks and half will receive the study drug every 6 weeks. Participants and the study doctor will know which group they have been allocated to. Only the doctor who administers the multiple sclerosis (MS) tests will not know which treatment group the participant is in. Participants will come to the study centre for 16 or 22 schedule visits depending on which group they are randomised to, over a 2-year period. During the study visits participants will have various tests to which will help the research team measure the effectiveness and the safety of the treatment.
Around 480 patients with multiple sclerosis (MS) in approximately 100 study centres in around 10 countries world-wide will take part in this study.
It is planned for one participant(volunteer)aged 18-58 from each research centre to participate in an MRI Test Scan to standardise scan methods used imaging sites.Summary of Results
The lay language summary is located here: https://www.biogentriallink.com/en-us/home/find-a-clinical-trial/clinical-trials-study-details.html?nctId=NCT03689972
REC name
Wales REC 1
REC reference
18/WA/0385
Date of REC Opinion
24 Jan 2019
REC opinion
Further Information Favourable Opinion