Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients (METHODA)

Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Ciclosporin; Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged > 18 years old.
• Both genders eligible for study.
• Moderate to severe AD.
• Scorad > 15.
• Participants must use a contraceptive method during the trial and for 3 months after the end of the trial for female and 5 months for male participants.
• Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
• Patients must be registered in a social security system or with a health insurance coverage.

Exclusion Criteria:

• Pregnant or lactating women.
• Evolutive skin disease.
• Patients with a clinically significant disease (chronic, recurrent or active).
• Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid the week before the inclusion.
• Contra-indication to methotrexate and cyclosporine.
• Exposure to phototherapy: cumulative dose > 2000 J/cm2.
• Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
• Patients under a protection measure.
• Patients in a critical medical situation.
• Patients with a personal situation evaluated by the investigator as unable to give optimal participation to the study, or where the study could constitute a risk for the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Ciclosporin	Drug: Ciclosporin; 5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
Experimental: 2; Methotrexate	Drug: Methotrexate; 15 mg/week per os in one tablet during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Decrease of scorad by 50% at week4,12,16,20 and 24	at week4,12,16,20 and 24
Decrease of scorad by 75% and 90 % at week 8 and 24	at week 8 and 24
quality of life at week 8 and 24	at week 8 and 24
Concentration of cytokines CCL17 and CCL18	at week 8 and 24
number of adverse events	36 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-François Nicolas, Professor, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Goujon C, Viguier M, Staumont-Salle D, Bernier C, Guillet G, Lahfa M, Ferrier Le Bouedec MC, Cambazard F, Bottigioli D, Grande S, Dahel K, Berard F, Rabilloud M, Mercier C, Nicolas JF. Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):562-569.e3. doi: 10.1016/j.jaip.2017.07.007. Epub 2017 Sep 28.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 17, 2008

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: methotrexate; ciclosporin; Atopic-dermatitis; scorad
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Calcineurin Inhibitors; Methotrexate; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 2007.476