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

Atopic Dermatitis Clinical Trial

— METHODA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809172
• Other study ID #: 2007.476
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: May 13, 2013
• Start date: December 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2009
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment		36 months	No
Secondary	Decrease of scorad by 50% at week4,12,16,20 and 24		at week4,12,16,20 and 24	No
Secondary	Decrease of scorad by 75% and 90 % at week 8 and 24		at week 8 and 24	No
Secondary	quality of life at week 8 and 24		at week 8 and 24	No
Secondary	Concentration of cytokines CCL17 and CCL18		at week 8 and 24	No
Secondary	number of adverse events		36 months	No