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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Afimkibart will be administered as SC injection.
Placebo will be administered as SC injection.
SunValley Arthritis Center Ltd.
Peoria, Arizona, United States
RECRUITINGUniversity of California Medical Center
La Jolla, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGInland Rheumatology Clinical Trials Incorporated
Upland, California, United States
Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
Time frame: Baseline, At Week 14
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Time frame: At Week 14
Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Tender Joint Count (TJC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in ACR20, ACR50 and ACR70 Response Rate
Time frame: Baseline, At Week 24
Change from Baseline in Simplified Disease Activity Index (SDAI) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in Clinical Disease Activity Index (CDAI) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in Short Form-36 Health Survey (SF-36) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score
Time frame: Baseline, At Week 24
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to Week 38
Serum Concentration of RO7790121 at Specified Timepoints
Time frame: Up to Week 38
Percentage of Participants With Anti-Drug Antibodies
Time frame: Baseline, Up to Week 38
Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
RECRUITINGWillow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
RECRUITINGAccurate Clinical Research Inc.
Lake Charles, Louisiana, United States
RECRUITINGHenry Ford Medical Center- New Center One
Detroit, Michigan, United States
RECRUITINGEquity Medical
The Bronx, New York, United States
RECRUITINGEquity Medical
The Bronx, New York, United States
RECRUITING...and 54 more locations