NEXUS- 24 week Study to investigate new medicine Namilumab in patients
Research type
Research Study
Full title
A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in patients with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study.
IRAS ID
159389
Contact name
Peter Taylor
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2013-002805-76
Research summary
The aim of this study is to learn if a medicine called namilumab improves both inflammation and pain control in patients who suffer from moderate to severe rheumatoid arthritis (RA). Furthermore, the study will also involve measuring the amount of namilumab in the blood following its administration to the patients, and investigation into how the human body responds to namilumab treatment. Namilumab is a medication not yet approved in any country; it is currently being investigated for use in relation to several different diseases, and has so far shown no specific safety issues.
Namilumab in different strengths or placebo (called the “study medication”) will be injected via a subcutaneous (lowest part of the skin) injection up to 19 times during the study.
During the course of this study the doctor will measure the effect of the treatment through the doctor’s assessments of the participant's RA, through questionnaires answered by the participant (both at the study site and at home), and also through measuring the levels of proteins in the participant's blood (these proteins are called biomarkers).REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1252
Date of REC Opinion
9 Oct 2014
REC opinion
Further Information Favourable Opinion