WA46440 dRAvite-LTE
Research type
Research Study
Full title
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials
IRAS ID
1013500
Contact name
Clinical Trial Accountable Regulatory Data and Content Chapter
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Research summary
This study will look at whether the medicine Afimkibart is safe and works well when taken for a long time by people with moderate to severe rheumatoid arthritis (RA). We also want to learn about any long-term effects—good or bad—of Afimkibart.
Afimkibart is an experimental medicine, which means it is not yet approved by health authorities for treating RA.Who can take part?
This study will enroll approximately 120 adults (aged 18 years or older) with moderate to severe rheumatoid arthritis who previously participated in the Afimkibart study WA45646 (also known as DRAVITE).What is Afimkibart?
Afimkibart is a type of medicine called an antibody. It targets a protein in the body called TL1A, which may play a role in joint inflammation. Earlier studies showed Afimkibart helped people with ulcerative colitis (a bowel condition). Based on this, we hope it may also help RA symptoms.What will happen in this study?
The study has three parts:
1. Screening – to check if the patient can join.
2. Treatment – Afimkibart will be injected under the skin every 4 weeks. Participants who had the low dose before in the WA45646 study, will keep getting the low dose. If the participant had the high dose or switched from placebo to high dose, they will keep getting the high dose.
3. Follow-up – we will check on the participant after treatment ends.How long will it last?
This study may last up to 6 years, or until Afimkibart becomes available for rheumatoid arthritis, or ends earlier.Roche Products Limited is the sponsor of this study.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0031
Date of REC Opinion
19 Mar 2026
REC opinion
Further Information Favourable Opinion