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)
Recruiting · NCT07137598 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
AfimkibartPlacebo
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has 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)
- 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 \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
Exclusion criteria
- Have failed more than two TNF inhibitors or JAK inhibitors
- Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
- Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
- History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
- History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
- Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
- History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
- History of organ transplant
- Any identified confirmed congenital or acquired immunodeficiency
- Abnormal laboratory values and liver function test
Where it is running
60 locations listed across 12 US states.
- SunValley Arthritis Center Ltd. - Peoria, Arizona, United States
- University of California Medical Center - La Jolla, California, United States
- Cedars Sinai Medical Center - Los Angeles, California, United States
- Inland Rheumatology Clinical Trials Incorporated - Upland, California, United States
- West Broward Rheumatology Associates, Inc. - Tamarac, Florida, United States
- Willow Rheumatology and Wellness PLLC - Willowbrook, Illinois, United States
- Accurate Clinical Research Inc. - Lake Charles, Louisiana, United States
- Henry Ford Medical Center- New Center One - Detroit, Michigan, United States
- Equity Medical - The Bronx, New York, United States
- Ohio State University Wexner Medical Center - Columbus, Ohio, United States
- Altoona Center For Clinical Research - Duncansville, Pennsylvania, United States
- Precision Comprehensive Clinical Research Solutions - Colleyville, Texas, United States
- Accurate Clinical Management - Houston, Texas, United States
- DM Clinical Research - Tomball, Texas, United States
- Tidewater Clinical Research - Chesapeake, Virginia, United States
- Rheumatic Disease Center - Glendale, Wisconsin, United States
- Barnet Hospital - Barnet, United Kingdom
- HUB Erasme - Brussels, Belgium
- Nzoz Bif-Med - Bytom, Poland
- Investigacion y Biomedicina de Chihuahua, Sociedad Civil - Chihuahua City, Mexico
- Centro Privado de Medicina Familiar - Mind Out Research - Ciudad Autonoma Buenos Aires, Argentina
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne - Elbl?g, Poland
- Bispebjerg og Frederiksberg Hospital - Frederiksberg, Denmark
- Sjllands Universitetshospital - Kge, Denmark
- Malopolskie Badania Kliniczne - Krakow, Poland
- UZ Leuven - Leuven, Belgium
- Zespol Poradni Specjalistycznych REUMED - Lublin, Poland
- Hospital Regional Universitario de Malaga - Málaga, Spain
- Twoja Przychodnia NCM - Nowa Sól, Poland
- Hpital Cochin - Paris, France
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica - San Juan, Argentina
- Hospital Universitario Virgen Macarena - Seville, Spain
- Hospital Quironsalud Infanta Luisa - Seville, Spain
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher - Warsaw, Poland
- Centrum Medyczne Reuma Park - Warsaw, Poland
- Reumatop Spolka Jawna - Wroclaw, Poland
- CHU Strasbourg Hpital Hautepierre - Strasbourg, Bas Rhin, France
- Hopital de la Conception - Marseille, Bouches-du-Rhne, France
- Centro Medico Arsema - Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina
- Centro de Investigaciones Medicas Mar Del Plata - Mar del Plata, Buenos Aires, Argentina
- APRILLUS Asistencia e Investigacion - Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
- Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Reggio Emilia, Emilia-Romagna, Italy
- L2IP ?Instituto de Pesquisas Clínicas Ltda. - Brasília, Federal District, Brazil
- Hopital Lapeyronie - Montpellier, Herault, France
- Complejo Hospitalario Universitario A Coruña - La Corua, LA Coruna, Spain
- Complejo Hospitalario Universitario de Santiago. - Santiago de Compostela, LA Coruna, Spain
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome, Lazio, Italy
- Leicester Royal Infirmary - Leicester, Leicestershire, United Kingdom
- Istituto Clinico Humanitas - Rozzano, Lombardy, Italy
- Hopital Purpan - Toulouse, Lot Et Garonne, France
- IPC MT Instituto de Pesquisas Clinicas do Mato Grosso - Cuiab, Mato Grosso, Brazil
- Centro Mineiro de Pesquisa - CMIP - Juiz de Fora, Minas Gerais, Brazil
- Rheumazentrum Ruhrgebiet - Herne, North Rhine-Westphalia, Germany
- Centro de Estudos em Terapias Inovadoras ? CETI - Curitiba, Paraná, Brazil
- Hospital So Lucas da PUCRS - Porto Alegre, Rio Grande do Sul, Brazil
- Städtisches Klinik Dresden-Friedrichstadt - Dresden, Saxony, Germany
- Centro de Investigacion de Tratam Innovadores de Sin SC - Culiacán, Sinaloa, Mexico
- Doncaster Royal Infirmary - Doncaster, South Yorkshire, United Kingdom
- Hospital das Clínicas FMRP-USP - Ribeirão Preto, São Paulo, Brazil
- CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos - So Paulo, São Paulo, Brazil
Showing 60 of 63 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →