Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Psoriasis Vulgaris Clinical Trial

Official title:

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02715947
• Other study ID #: 2016 MTX/CSU/PS
• Status: Recruiting
• Phase: Phase 2
• First received: March 17, 2016
• Last updated: March 21, 2016
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Central South University
• Contact: Yijing He, MD,PhD
• Phone: +86-1587481262
• Email: yijinghe[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Methotrexate
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.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease control rate		8 weeks after the first treatment	No