Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Phase 2

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Methotrexate

• Registration Number: NCT02715947
• Lead Sponsor: Central South University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	Methotrexate	intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.

Primary Outcome Measures

Name	Time	Method
disease control rate	8 weeks after the first treatment

Trial Locations

Locations (1)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China