Last updated 18 days ago
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)
160 patients around the world
Available in United States, Brazil
Hoffmann-La Roche
1Research sites
160Patients around the world
This study is for people with
Arthritis
Rheumatoid arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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).
- 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 of 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.
Sites
L2IP Instituto de Pesquisas Clínicas - Brasilia
Recruiting
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Rheumatoid arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07137598
