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

Abivax S.A.40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

ABX464DRUG

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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

Locations (14)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

CHU de Brest - Hôpital Cavale Blanche

Brest, France

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity

Incidence of adverse events emerging during the treatment

Time frame: through study completion (average of 104 weeks)

Secondary Outcomes

Proportion of patients achieving Low Disease Activity (LDA)

Low Disease Activity (LDA) is defined as DAS28-ESR \<=3.2

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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