Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    60
  • sponsor
    Abivax S.A.
Updated on 26 September 2021
Investigator
Paul GINESTE
Primary Contact
CRU Hungary Ltd. (0.0 mi away) Contact
+31 other location
tumor necrosis factor

Summary

A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

Description

This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.

All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP 2,6 for anti-TNF nave patients or DAS-28-CRP 3,2 for patients previously treated by anti-TNF), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment ABX464
Clinical Study IdentifierNCT04049448
SponsorAbivax S.A.
Last Modified on26 September 2021

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