DRAVITE
Research type
Research Study
Full title
A PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF RO7790121 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE OR INTOLERANCE TO TNF AND/OR JAK INHIBITORS
IRAS ID
1012950
Contact name
Clinical Trial Accountable Regulatory Data and Content Chapter
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Research summary
A study to assess the efficacy and safety of RO7790121 in patients with moderate to severe rheumatoid arthritis who have not responded to or who cannot tolerate TNF and/or JAK inhibitors.
The purpose of this study is to find out what effects, good or bad, RO7790121 has on patients with moderate to severe rheumatoid arthritis.
This study is testing a medicine called RO7790121. It is being developed to treat moderate to severe RA.
RO7790121 is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved RO7790121 for the treatment of RA.
This study aims to compare the effects of RO7790121 against non-active medicine (placebo) and to check how safe it is in people with moderate to severe RA.
People (males and females) of 18 years or older with moderate to severe RA can take part in the study. In this study, patients will get either RO7790121 or placebo.
This study has three parts:
1. Screening (to see if you are eligible for the study)
2. Treatment
3. Follow-up (to check on you after treatment is finished)
After screening, patient will be placed in one of the following treatment groups:
● RO7790121 (high dose)
● RO7790121 (low dose)
● Placebo
Both RO7790121 and placebo will be injected under the skin (subcutaneously).
The treatment part of the study will be 24 weeks.
Total time in the study for patients will be about 42 weeks from enrolment.
The main results measured in the study to assess if the medicine has worked are the changes in the DAS28 CRP score. This score helps to see how active the RA disease is. This score is based on how many joints are swollen or painful, how the study doctors and participants rate the severity of arthritis and the level of C-Reactive protein (a substance in blood that shows inflammation).
About 160 people will take part in this study.
Roche Products Limited is the sponsor of this study.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0243
Date of REC Opinion
20 Nov 2025
REC opinion
Further Information Favourable Opinion