Clinical trial NCT02715947: Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
Official title: Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis Vulgaris
Methotrexate
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed according to Classification criteria for Psoriasis vulgaris
2. Patients aged 18 to 70 years (to the date of screening)
3. Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream
4. Phototherapy nearly one months before enrolled
5. 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
6. Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria:

1. Pregnant women, ready to pregnant or lactating women
2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year
5. Patients suffering from malignant tumor
6. Patients suffering from acute and chronic infectious diseases
7. Mental disorders, history of alcohol abuse, drug or other substance abuse
8. Other cases which researchers believe that can not enroll

Primary outcomes:
measure: disease control rate
timeFrame: 8 weeks after the first treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Xiang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: