Actively Recruiting
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
Led by Hoffmann-La Roche · Updated on 2026-05-04
160
Participants Needed
46
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has moderate to severe active rheumatoid arthritis with at least 6 swollen and 6 tender joints at screening and baseline
- Diagnosed with rheumatoid arthritis for 3 months or more and meets 2010 ACR/EULAR criteria
- Has had an inadequate response, loss of response, or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD)
You will not qualify if you...
- Have failed more than two TNF inhibitors or JAK inhibitors
- Class IV rheumatoid arthritis according to ACR revised criteria
- Past or current use of other biologic DMARDs (excluding TNF inhibitors) or rituximab
- Treatment with investigational therapy within 4 weeks or within 5 half-lives before study treatment
- History of arthritis starting before age 17 or other inflammatory joint diseases
- Received corticosteroids by certain routes in the 8 weeks before the first dose
- History of severe allergic or anaphylactic reactions to study drug components or similar products
- Major surgery within 6 weeks before screening or planned during the study
- Serious, chronic, or unstable medical or psychiatric conditions
- History of malignancy except certain treated non-metastatic skin or cervical cancers
- Severe chronic or recurrent infections
- History of active hepatitis B, hepatitis C, or HIV infection
- History of organ transplant
- Confirmed congenital or acquired immunodeficiency
- Abnormal laboratory or liver function tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
SunValley Arthritis Center Ltd.
Peoria, Arizona, United States, 85381
Actively Recruiting
2
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States, 91786
Actively Recruiting
3
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States, 33321
Actively Recruiting
4
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States, 60527
Actively Recruiting
5
Accurate Clinical Research Inc.
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
6
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43203
Actively Recruiting
7
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
8
Accurate Clinical Management
Houston, Texas, United States, 77089
Actively Recruiting
9
DM Clinical Research
Tomball, Texas, United States, 77375
Actively Recruiting
10
Tidewater Clinical Research
Chesapeake, Virginia, United States, 23320
Actively Recruiting
11
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
Actively Recruiting
12
Centro Medico Arsema
Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina, C1427
Actively Recruiting
13
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1406AGA
Actively Recruiting
14
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, Argentina, C1417EYH
Actively Recruiting
15
HUB Erasme
Brussels, Belgium, 1070
Actively Recruiting
16
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
17
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
18
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso, Brazil, 78020-500
Actively Recruiting
19
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Actively Recruiting
20
Centro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná, Brazil, 80030-110
Actively Recruiting
21
Hospital So Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
22
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
23
CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos
So Paulo, São Paulo, Brazil, 04266-010
Actively Recruiting
24
Bispebjerg og Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Actively Recruiting
25
Sjllands Universitetshospital
Kge, Denmark, 4600
Actively Recruiting
26
CHU Strasbourg Hpital Hautepierre
Strasbourg, Bas Rhin, France, 67091
Actively Recruiting
27
Hopital de la Conception
Marseille, Bouches-du-Rhne, France, 13005
Actively Recruiting
28
Hopital Lapeyronie
Montpellier, Herault, France, 34295
Actively Recruiting
29
Hopital Purpan
Toulouse, Lot Et Garonne, France, 31059
Actively Recruiting
30
Hpital Cochin
Paris, France, 75014
Actively Recruiting
31
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, Germany, 44649
Actively Recruiting
32
Städtisches Klinik Dresden-Friedrichstadt
Dresden, Saxony, Germany, 01067
Actively Recruiting
33
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
34
Nzoz Bif-Med
Bytom, Poland, 41-902
Actively Recruiting
35
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
Elbl?g, Poland, 82-300
Actively Recruiting
36
Malopolskie Badania Kliniczne
Krakow, Poland, 30-002
Actively Recruiting
37
Zespol Poradni Specjalistycznych REUMED
Lublin, Poland, 20-607
Actively Recruiting
38
Twoja Przychodnia NCM
Nowa Sól, Poland, 67-100
Actively Recruiting
39
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warsaw, Poland, 02-637
Actively Recruiting
40
Centrum Medyczne Reuma Park
Warsaw, Poland, 02-665
Actively Recruiting
41
Reumatop Spolka Jawna
Wroclaw, Poland, 52-210
Actively Recruiting
42
Hospital Regional Universitario de Malaga
Málaga, Spain, 29009
Actively Recruiting
43
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
44
Doncaster Royal Infirmary
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Actively Recruiting
45
North Tyneside General Hospital
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE29 8NH
Actively Recruiting
46
Barnet Hospital
Barnet, United Kingdom, EN5 3DJ
Actively Recruiting
Research Team
R
Reference Study ID Number: WA45846 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here