Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
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.
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-TNFα naïve patients or DAS-28-CRP ≤
 3,2 for patients previously treated by anti-TNFα), 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).
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-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by
 anti-TNFα.

 Exclusion Criteria:

 -  Any condition, which in the opinion of the investigator, could compromise the
 patient's safety or adherence to the study protocol