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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: ABX464


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, follow-up study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABX464 50 mg<br>All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks) | Drug: ABX464<br>* All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity | Incidence of adverse events emerging during the treatment | through study completion (average of 104 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving Low Disease Activity (LDA) | Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2 | Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104 | 
| Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission | The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1 | Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104 | 
| Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission | The SDAI remission is considered achieved if the SDAI score ≤ 3.3 | Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104 | 
| Proportion of patients achieving Clinical Disease Activity (CDAI) remission | The CDAI remission is considered achieved if the CDAI score ≤ 2.8 | 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 | The categorical American College of Rheumatology 20% or 50% or 70% (ACR20/50/70) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% or 50% or 70% improvement in the ACR response. | Week 4, Week 12, Week 24, 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 | Proportion of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response | 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 | time when DAS28-ESR <=3.2 | up to 104 weeks | 
| Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission | The ACR/EULAR remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1. Time to onset will be when this criteria will be ≤ 1 | up to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate to severe Rheumatoid Arthritis