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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Afimkibart

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Afimkibart Group IExperimental treatment 1 intervention
Group B: Afimkibart Group IIExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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