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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

  Purpose

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.

Condition Intervention Phase
Psoriasis Vulgaris Drug: Methotrexate Phase 2

Study Type: Interventional
Study Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Resource links provided by NLM:

Further study details as provided by Yijing He, Central South University:

Primary Outcome Measures:

  • disease control rate [ Time Frame: 8 weeks after the first treatment ]

Estimated Enrollment:400
Study Start Date:December 2015
Estimated Study Completion Date:December 2017
Estimated Primary Completion Date:December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-arm

intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.
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.
Other Name: Amethopterin

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.

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