A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abivax S.A.
- Enrollment
- 40
- Locations
- 14
- Primary Endpoint
- Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 76 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ABX464 50 mg
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks)
Intervention: ABX464 (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
Time Frame: through study completion (average of 104 weeks)
Incidence of adverse events emerging during the treatment
Secondary Outcomes
- Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission(Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)
- Time to onset of the Low Disease Activity (LDA) remission(up to 104 weeks)
- Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission(Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)
- Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response(Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)
- Proportion of patients achieving ACR20/50/70 response(Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)
- Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission(up to 104 weeks)
- Proportion of patients achieving Clinical Disease Activity (CDAI) remission(Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)
- Proportion of patients achieving Low Disease Activity (LDA)(Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104)