2025-521034-28-00RecruitingPhase 2
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Sept 2026
Brief summary (registry, in English)
To evaluate the efficacy of RO7790121 compared with placebo with respect to change from baseline in Disease Activity Score-28 C-Reactive Protein (DAS28-CRP) at Week 14
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 89 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 5 Dec 2025
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2025-521034-28-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 89
- 31 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe active rheumatoid arthritis who did not respond to, lost response to, or could not tolerate TNF and/or JAK inhibitor medicines.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Moderate to severe active rheumatoid arthritis: at least 6 swollen joints and at least 6 tender joints, diagnosed at least 3 months ago and meeting the 2010 ACR/EULAR criteria
- Earlier treatment
- Must have had an inadequate response, loss of response or intolerance to one or more TNF/JAK inhibitors
Main reasons for not taking part
- Class IV rheumatoid arthritis (ACR revised response criteria)
- Major surgery within 6 weeks before screening, or planned during the study
- History of organ transplant
- Acquired or congenital immunodeficiency
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
Other illness
- History of organ transplant
Other
- Class IV RA according to ACR revised response criteria
- Acquired or congenital immunodeficiency
Who the study is looking for
- Have moderate to severe active RA defined by the presence of ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline (based on 66/68-joint count)
- Agreement to adhere to the contraception requirements
- Diagnosis of RA for ≥ 3 months and also fulfills the 2010 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
- Demonstrated an inadequate response or loss of response to or intolerance to one or more TNF/JAK inhibitor(s)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme | Anderlecht | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Staedtisches Klinikum Dresden | Dresden | Germany | Recruiting |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH | Hamburg | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr | Herne | Germany | Recruiting |
| Studienambulanz Rheumazentrum Ratingen GbR | Ratingen | Germany | Recruiting |
| Region Hovedstaden | Copenhagen Nv | Denmark | Recruiting |
| Region Sjaelland | Koege | Denmark | Recruiting |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Recruiting |
| Hospital Quironsalud Infanta Luisa | Sevilla | Spain | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Hopital Cochin Saint Vincent De Paul | Paris | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Recruiting |
| Azienda Ospedaliera di Padova | Padova | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Recruiting |
| BIF-MED | Bytom | Poland | Recruiting |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. | Elblag | Poland | Recruiting |
| Reumed Sp. z o.o. | Lublin | Poland | Recruiting |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. | Nowa Sol | Poland | Recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. | Warsaw | Poland | Recruiting |
| Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.