An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis (dRAvite-LTE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Afimkibart

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WA46440 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afimkibart Group II; Participants will receive Afimkibart as SC injection.	Drug: Afimkibart; Participants will receive Afimkibart as per the schedule mentioned in the protocol.; Other Names: RVT-3101; PF-06480605; RO7790121
Experimental: Afimkibart Group I; Participants will recieve Afimkibart as subcutaneous (SC) injection.	Drug: Afimkibart; Participants will receive Afimkibart as per the schedule mentioned in the protocol.; Other Names: RVT-3101; PF-06480605; RO7790121

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Adverse Events (AEs)	From Baseline up to 6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)	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 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): June 5, 2032
• Study Completion (Estimated): June 5, 2032

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: WA46440; 2025-523579-47-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No