An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Afimkibart.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials
Overview
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
- Drug Afimkibart
Participants will receive Afimkibart as per the schedule mentioned in the protocol.
Primary outcome measures
- Percentage of Participants With Adverse Events (AEs) [Time frame: From Baseline up to 6 years]
Secondary outcome measures (12)
- Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) [Time frame: Up to 6 years]
- Change from baseline in Individual Components of ACR [Time frame: Baseline, Up to 6 years]
- Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP) [Time frame: Baseline, Up to 6 years]
- Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score [Time frame: Up to 6 years]
- Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score [Time frame: Up to 6 years]
- Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score [Time frame: Up to 6 years]
- Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score [Time frame: Up to 6 years]
- Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score [Time frame: Up to 6 years]
- Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score [Time frame: Up to 6 years]
- Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score [Time frame: Up to 6 years]
- Serum Concentration of Afimkibart [Time frame: Up to 6 years]
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart at Baseline and with ADAs to Afimkibart During the Study [Time frame: Baseline, Up to 6 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- West Broward Rheumatology Associates, Inc. — Tamarac
- Accurate Clinical Management LLC — Houston
- DM Clinical Research — Tomball
Poland · 3 centers
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne — Elblag
- Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda — Lublin
- Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna — Wroclaw
Identifiers
NCT: NCT07620392 · WA46440 · 2025-523579-47-00