A multicenter randomized study of the efficacy of methotrexate (MTX) tablets versus cyclosporine (Cy) capsules in moderate to severe atopic dermatitis (AD) in adults

INTERVENTION: Trade Name: NOVATREX Product Name: METHOTREXATE Pharmaceutical Form: Tablet Trade Name: NEORAL Product Name: CICLOSPORIN Pharmaceutical Form: Capsule* CONDITION: Atopic dermatitis; MedDRA version: 9.1 Level: LLT Classification code 10012438 Term: Atopic dermatitis PRIMARY OUTCOME: Main Objective: To demonstrate the clinical efficacy of the oral form of methotrexate in patients with moderate to severe atopic dermatitis. Cyclosporine, the reference treatment for severe forms of AD, is used as a comparator. Primary endpoint(s): A person, called a blinded evaluator, different from the study investigator and unaware of the patient's medications, will be responsible for the clinical evaluation of the scores. Primary endpoint: Proportion of patients with objective improvement as defined by a decrease in SCORAD = 50% after 8 weeks of treatment. Secondary efficacy endpoints: - Scorad 50 (i.e., a 50% decrease in Scorad score at weeks 4, 12, 16, 20, and 24); - Scorad 75 and 90 (i.e., a 75% and 90% decrease in Scorad score, respectively) at weeks 8 and 24; - Patient quality of life (DLQI questionnaire, designed to assess adult quality of life in dermatology, Appendix 2) every 4 weeks; - Soluble markers of inflammation (coordinating center only): TARC/CCL17, PARC/CCL18 at weeks 8 and 24; - Time to relapse, defined as a Scorad score greater than or equal to 75% of the baseline score in good responders; Secondary tolerability endpoints: Number of adverse clinical and biological events reported with MTX and Cy and those leading to premature discontinuation of treatment; Secondary Objective: Evaluation of methotrexate tolerability; Monitoring of biological markers of inflammation