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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715947
Recruitment Status : Unknown
Verified December 2015 by Yijing He, Central South University.
Recruitment status was:  Recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Yijing He, 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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Methotrexate Phase 2

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. disease control rate [ Time Frame: 8 weeks after the first treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715947


Contacts
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Contact: Yijing He, MD,PhD +86-1587481262 yijinghe@gmail.com

Locations
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China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Yijing He, MD, PhD    +86-1587481262    yijinghe@gmail.com   
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Xiang Chen, MD Xiangya Hospital of Central South University
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Responsible Party: Yijing He, Associate Professor, Central South University
ClinicalTrials.gov Identifier: NCT02715947    
Other Study ID Numbers: 2016 MTX/CSU/PS
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yijing He, Central South University:
Psoriasis Vulgaris
Methotrexate
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors