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NCT Number: NCT07620392

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centrum Medyczne Reuma Park, Warsaw, Masovian Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afimkibart

Drug

Participants will receive Afimkibart as per the schedule mentioned in the protocol.

Other names: PF-06480605, RVT-3101, RO7790121

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: From Baseline up to 6 years

Secondary outcomes

  1. Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)

    Time frame: Up to 6 years

  2. Change from baseline in Individual Components of ACR

    Time frame: Baseline, Up to 6 years

  3. Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP)

    Time frame: Baseline, Up to 6 years

  4. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score

    Time frame: Up to 6 years

  5. 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

  6. Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score

    Time frame: Up to 6 years

  7. Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score

    Time frame: Up to 6 years

  8. Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score

    Time frame: Up to 6 years

  9. Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score

    Time frame: Up to 6 years

  10. Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score

    Time frame: Up to 6 years

  11. Serum Concentration of Afimkibart

    Time frame: Up to 6 years

  12. 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

  13. Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart

    Time frame: Up to 6 years

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: dRAvite-LTE

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Jun 2, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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