Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFα therapy: a placebo-controlled phase II study.
Claire Immediato DaienMarek KrogulecPaul GinesteJean-Marc SteensLaurence Desroys du RoureSophie BiguenetDidier ScherrerJulien SantoHartmut EhrlichPatrick DurezPublished in: Annals of the rheumatic diseases (2022)
Phase IIa randomised, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with MTX, in patients with moderate to severe active RA who have inadequate response to MTX or/and to an anti- TNFα therapy or intolerance to anti-TNFα therapy.EUDRACT number: 2018-004677-27 TRIAL REGISTRATION NUMBER: NCT03813199.
Keyphrases
- placebo controlled
- rheumatoid arthritis
- double blind
- phase ii study
- phase iii
- phase ii
- study protocol
- clinical trial
- open label
- disease activity
- cell proliferation
- randomized controlled trial
- long noncoding rna
- interstitial lung disease
- early onset
- systemic lupus erythematosus
- high intensity
- mesenchymal stem cells
- low dose
- squamous cell carcinoma
- idiopathic pulmonary fibrosis
- rectal cancer