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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ciclosporin
Methotrexate
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic-dermatitis, scorad, methotrexate, ciclosporin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Ciclosporin

Methotrexate

Outcomes

Primary Outcome Measures

proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2008
Last Updated
May 13, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00809172
Brief Title
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Acronym
METHODA
Official Title
Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic-dermatitis, scorad, methotrexate, ciclosporin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Ciclosporin
Arm Title
2
Arm Type
Experimental
Arm Description
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Ciclosporin
Intervention Description
5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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
Primary Outcome Measure Information:
Title
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Decrease of scorad by 50% at week4,12,16,20 and 24
Time Frame
at week4,12,16,20 and 24
Title
Decrease of scorad by 75% and 90 % at week 8 and 24
Time Frame
at week 8 and 24
Title
quality of life at week 8 and 24
Time Frame
at week 8 and 24
Title
Concentration of cytokines CCL17 and CCL18
Time Frame
at week 8 and 24
Title
number of adverse events
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Nicolas, Professor
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28967549
Citation
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.
Results Reference
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Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

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