Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02715947

Enrollment

400

Registered

2016-03-22

Start date

2015-12-31

Completion date

2017-12-31

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis Vulgaris, Methotrexate

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.

Interventions

DRUGMethotrexate

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
disease control rate	8 weeks after the first treatment

Countries

China

Contacts

Primary ContactYijing He, MD,PhD

yijinghe@gmail.com+86-1587481262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026