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

Purpose

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.

Condition

  • Rheumatoid Arthritis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • PF-06480605
    • RVT-3101
    • RO7790121
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:
    • PF-06480605
    • RVT-3101
    • RO7790121

Recruiting Locations

DM Clinical Research
Tomball, Texas 77375

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below.
888-662-6728
global-roche-genentech-trials@gene.com