At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Afimkibart (drug), Placebo (drug)
- How long the study runs
- Study runs about 22 months (dates as stated)
- About the drug or intervention
- Afimkibart — drug: Afimkibart will be administered as SC injection. · Placebo — drug: Placebo will be administered as SC injection.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 160
- Started
- 2025-12-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for rheumatoid arthritis
- • Phase2 - 160 participants
- • This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with rheumatoid arthritis
Where?
- • Leicester - Leicester Royal Infirmary
- • Doncaster - Doncaster Royal Infirmary
- • Newcastle upon Tyne - North Tyneside General Hospital
- • Barnet - Barnet Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening...
- ✓Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance...
- ✓Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic...
Who cannot take part
- ✗Have failed more than two TNF inhibitors or JAK inhibitors
- ✗Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- ✗Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or...
- ✗Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy,...
- ✗History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other...
See the full criteria
Where Is This Study? (4 UK sites)
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Doncaster Royal Infirmary
Doncaster DN2 5LT, United Kingdom
North Tyneside General Hospital
Newcastle upon Tyne NE29 8NH, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Barnet Hospital
Barnet EN5 3DJ, United Kingdom
How to Get in Touch
Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
