Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGAfimkibart
Afimkibart will be administered as SC injection.
DRUGPlacebo
Placebo will be administered as SC injection.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) | Baseline, At Week 14 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) | At Week 14 |
| Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Tender Joint Count (TJC) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Patient's Global Assessment of Arthritis Pain-Visual Analog Scale (PGA Arthritis Pain-VAS) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Patient's Global Assessment of Disease Activity-Visual Analog Scale (PaGADA-VAS) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI) | Baseline, At Week 14 and Week 24 |
| Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP) | Baseline, At Week 14 and Week 24 |
| Change from Baseline in ACR20, ACR50 and ACR70 Response Rate | Baseline, At Week 24 |
| Change from Baseline in Simplified Disease Activity Index (SDAI) Score | Baseline, At Week 14 and Week 24 |
| Change from Baseline in Clinical Disease Activity Index (CDAI) Score | Baseline, At Week 14 and Week 24 |
| Change from Baseline in Short Form-36 Health Survey (SF-36) Score | Baseline, At Week 14 and Week 24 |
| Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score | Baseline, At Week 24 |
| Percentage of Participants With Adverse Events (AEs) | Up to Week 38 |
| Serum Concentration of RO7790121 at Specified Timepoints | Up to Week 38 |
| Percentage of Participants With Anti-Drug Antibodies | Baseline, Up to Week 38 |
Countries
Argentina, Belgium, Brazil, Denmark, France, Germany, Italy, Mexico, Poland, Spain, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed