MS200588-0004, Safety & Efficacy of MSB11022 in Rheumatoid Arthritis
Research type
Research Study
Full title
A multicenter, randomized, double-blind, phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis
IRAS ID
215022
Contact name
Christopher Edwards
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2016-002852-26
Duration of Study in the UK
1 years, 7 months, 6 days
Research summary
This is a phase 3 multicentre, double blind study of an investigational drug called MSB11022.
The purpose of the study is to find out if MSB11022, the study drug, is as safe and effective as Humira®, an existing medication, for the treatment of moderate to severe Rheumatoid Arthritis (RA).
Aproximately 260 people will participate in this study. The study will be conducted in approximately 60 medical centres in eight countries. The study will last until 2018.
The study is made up of a screening period lasting up to 4 weeks, a treatment period of up to 52 weeks and a follow-up period lasting up to 16 weeks after the last dose of study medication.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0548
Date of REC Opinion
5 Jan 2017
REC opinion
Further Information Favourable Opinion