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Taking people in ItalyPhase 2

Tests RO7790121 against placebo in adults with rheumatoid arthritis after other medicines

Tests RO7790121 against placebo in adults with moderate to severe rheumatoid arthritis.

Key facts

Who runs it
F. Hoffmann-La Roche AG
Where
Padova, Reggio Emilia, Rome, and Rozzano, ItalySee the 4 sitesAlso in 6 other countries, 27 sites
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
89 people, planned
Started
5 Dec 2025
Expected to end
18 Jul 2027
Type of study
Interventional
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
  • History of organ transplant
  • Class IV RA according to ACR revised response criteria
  • Acquired or congenital immunodeficiency

Where in Italy

Also in 6 other countries, 27 sites

  • Azienda Ospedaliera di PadovaPadova, ItalyTaking people
  • Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests RO7790121 against placebo in adults with rheumatoid arthritis after other medicinesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
14 September 2026