Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Study Overview
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Brief Summary
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To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.

Detailed Description
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Previous studies have indicated that the gene mutations of absorption distribution metabolism and drug target may affect the efficacy of Methotrexate in vivo.To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME(absorption, distribution, metabolism and excretion) affect the efficacy of Methotrexate; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Methotrexate.

Official Title
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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed according to Classification criteria for Psoriasis vulgaris Patients aged 18 to 70 years (to the date of screening) Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream Phototherapy nearly one months before enrolled Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN, if not liver metastases < 5 x ULN, if known liver metastases, Creatinine clearance <1.5 x ULN Understanding the whole process of the study, voluntary participation and signed the informed consent Exclusion Criteria: Pregnant women, ready to pregnant or lactating women Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers Patients with chronic diarrhea, or peptic ulcer nearly 1 year Patients suffering from malignant tumor Patients suffering from acute and chronic infectious diseases Mental disorders, history of alcohol abuse, drug or other substance abuse Other cases which researchers believe that can not enroll

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm<br>intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral. | Drug: Methotrexate<br>* During The first week: 7.5mg per week, oral; The second and third weeks: 10mg per week, oral; The fourth and fifth weeks: 12.5mg per week,oral; The sixth week:15mg per week, and maintain this dose, oral.<br>* Other names: Amethopterin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate |  | 8 weeks after the first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis Vulgaris, Methotrexate