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
Key facts
- Where
- A Coruña, Barcelona, Córdoba, Madrid, Málaga, Santiago de Compostela és Sevilla, SpanyolországSee the 8 sites
- Phase
- 2. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Reina SofiaCórdoba, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
- Hospital Universitario Regional de MálagaMálaga, SpanyolországTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországTaking people
- Hospital Quironsalud Infanta LuisaSevilla, SpanyolországTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2025-521034-28-00
- Record updated
- 2026. szeptember 14.
- Original description
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 14Read full original descriptionShow less
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
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
Inclusion: 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).
Exclusion: 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.