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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00809172
First received: December 16, 2008
Last updated: May 13, 2013
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Ciclosporin
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease of scorad by 50% at week4,12,16,20 and 24 [ Time Frame: at week4,12,16,20 and 24 ] [ Designated as safety issue: No ]
  • Decrease of scorad by 75% and 90 % at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • quality of life at week 8 and 24 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • Concentration of cytokines CCL17 and CCL18 [ Time Frame: at week 8 and 24 ] [ Designated as safety issue: No ]
  • number of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2008
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00809172

Locations
France
Hospices Civils de Lyon
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-François Nicolas, Professor Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00809172     History of Changes
Other Study ID Numbers: 2007.476
Study First Received: December 16, 2008
Last Updated: May 13, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Atopic-dermatitis
scorad
methotrexate
ciclosporin

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Methotrexate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 26, 2014