Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABX464 50mg; Matching Placebo; ABX464 100mg; Methotrexate
Intervention description: ABX464 is a new anti-inflammatory drug; placebo matching with ABX464; ABX464 is a new anti-inflammatory drug; MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of
      ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to
      severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one
      or more anti- tumor necrosis factor alpha (TNFα) therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis,
             for at least 12 weeks, according to the revised 2010 American College of Rheumatology-
             European League Against Rheumatism (ACR-EULAR) classification criteria, including at
             least one positive criteria among the following: Rheumatoid Factor (RF),
             Anti-Citrullinated Peptide Antibody (ACPA) or bone erosion;

          -  Swollen joint count (SJC) of ≥ 4 (28-joint count) and tender joint count (TJC) ≥4
             (28-joint count) at screening;

          -  Patient with a moderate to severe disease activity score Disease Activity Score (28
             joints) C-Reactive Protein [DAS28 CRP] ≥ 3.2 and C-reactive Protein (CRP) ≥ 5 mg/L (≥
             4.76 nmol)/L) at screening;

          -  Patient who had an inadequate response (IR), or failed either methotrexate (MTX)
             or/and anti- Tumor Necrosis Factor alpha (TNFα) therapy (both administered for at
             least 12 weeks before IR) or were intolerant to anti- TNFα therapy.

        Exclusion Criteria:

          -  Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA
             [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE);

          -  Patient with known active infections at screening such as CytoMegaloVirus (CMV),
             herpes virus and/or recent infectious hospitalization;

          -  Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic,
             pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable
             Central Nervous System (CNS) pathology such as seizure disorder, angina or cardiac
             arrhythmias, active malignancy or any other clinically significant medical problems as
             determined by physical examination and/or laboratory screening tests and/or medical
             history;

          -  Acute, chronic or history of immunodeficiency or other autoimmune disease;

          -  Patient previously treated with any non-anti-TNF biological Disease-Modifying
             AntiRheumatic Drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline.