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

August 20, 2026 updated by: Hoffmann-La Roche

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Poland
      • Bytom, Poland, 41-902
        • Recruiting
        • Nzoz Bif-Med
      • Elblag, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
      • Lublin, Poland, 20-607
        • Recruiting
        • Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia NCM
      • Wroclaw, Poland, 52-210
        • Recruiting
        • Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna
  • United States
    • Florida
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates, Inc.
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Accurate Clinical Research Inc.
    • Texas
      • Houston, Texas, United States, 77089
        • Recruiting
        • Accurate Clinical Management LLC
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: From Baseline up to 6 years
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)
Time Frame: Up to 6 years
Up to 6 years
Change from baseline in Individual Components of ACR
Time Frame: Baseline, Up to 6 years
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
Baseline, Up to 6 years
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score
Time Frame: Up to 6 years
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
Up to 6 years
Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score
Time Frame: Up to 6 years
Up to 6 years
Serum Concentration of Afimkibart
Time Frame: Up to 6 years
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
Baseline, Up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

July 8, 2033

Study Completion (Estimated)

July 8, 2033

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)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA46440
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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