Rheumatoid Arthritis
Conditions
Brief summary
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.
Interventions
DRUGAfimkibart
Participants will receive Afimkibart as per the schedule mentioned in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed the treatment period of the parent study * Agreement to adhere to the contraception requirements * Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline
Exclusion criteria
* Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * Use of a prohibited therapy during the parent study * Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | From Baseline up to 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score | Up to 6 years |
| Serum Concentration of Afimkibart | Up to 6 years |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart at Baseline and with ADAs to Afimkibart During the Study | Baseline, Up to 6 years |
| Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart | Up to 6 years |
| Change from baseline in Individual Components of ACR | Baseline, Up to 6 years |
| Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP) | Baseline, Up to 6 years |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score | Up to 6 years |
| Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score | Up to 6 years |
| Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) | Up to 6 years |
Countries
Poland, United States
Contacts
CONTACTReference Study ID Number: WA46440 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