MT203-2004 TELLUS: Namilumab & Adalimumab in Rheumatoid Arthritis
Research type
Research Study
Full title
A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate. A Phase 2 Exploratory Study of Namilumab vs Anti–Tumor Necrosis Factor in Patients With Early Rheumatoid Arthritis Inadequately Responding to Methotrexate
IRAS ID
166668
Contact name
Peter Taylor
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2014-002945-23
Duration of Study in the UK
1 years, 8 months, 16 days
Research summary
The aim of this study is to determine the effect of a medicine called Namilumab in combination with existing methotrexate (MTX) over 24 weeks in patients with moderate to severe Rheumatoid Arthritis who have been diagnosed in the last 6 months and who are insufficiently controlled by MTX alone. Furthermore, the study is designed to investigate maintenance of response after discontinuation of the treatment at Week 22. For this reason after Week 24, subjects will be followed up in the clinic every 8 weeks until Week 40 (study end).
The study will be open-label and a total of 36 participants will be randomised in a 2:1 ratio to receive either namilumab combined with MTX or adalimumab combined with MTX.
The study consists of the following periods:
• Screening Period (Week -4/-2 to Baseline Visit).
• Treatment Period (Baseline Visit [Day 1] to Week 24).
• Follow-up Period (Week 25 to Week 40).
• End of Study Visit (Week 40).During the course of this study the doctor will measure the effect of the treatment by MRI, 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
15/SC/0020
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion