Status:
COMPLETED
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
Abivax S.A.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα.
Exclusion
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04049448
Start Date
October 25 2019
End Date
January 23 2023
Last Update
November 17 2025
Active Locations (14)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
UZ Gent
Ghent, Belgium
3
CHU de Brest - Hôpital Cavale Blanche
Brest, France
4
CHU DE MONTPELLIER - Hôpital Lapeyronie
Montpellier, France