NCT02715947

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-03-22
• Last updated: 2016-03-22

Locations

1 site across 1 country: China