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 1 February 2021
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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 on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period
Criteria that should be met by patients at week 52 to be eligible for 52
additional weeks of study treatment
Patients should be in clinical response. Clinical response is defined as
DAS28-CRP 2,6 for anti-TNF nave patients or DAS-28-CRP 3,2 for patients
previously treated by anti-TNF

Exclusion Criteria

Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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