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Completed

NCT Number: NCT04049448

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABX464

Drug

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

Primary outcomes

  1. 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

  1. Proportion of patients achieving Low Disease Activity (LDA)

    Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

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

  2. Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission

    Time frame: Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

    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

  3. Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission

    Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

    The SDAI remission is considered achieved if the SDAI score ≤ 3.3

  4. Proportion of patients achieving Clinical Disease Activity (CDAI) remission

    Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

    The CDAI remission is considered achieved if the CDAI score ≤ 2.8

  5. Proportion of patients achieving ACR20/50/70 response

    Time frame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

    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.

  6. Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response

    Time frame: 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 Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response

  7. Time to onset of the Low Disease Activity (LDA) remission

    Time frame: up to 104 weeks

    time when DAS28-ESR <=3.2

  8. Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission

    Time frame: up to 104 weeks

    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

Sponsors and collaborators

Lead sponsor

Abivax S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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