- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02715947
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
March 21, 2016 updated by: Yijing He, Central South University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yijing He, MD,PhD
- Phone Number: +86-1587481262
- Email: yijinghe@gmail.com
Study Locations
-
-
Hunan
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Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital Central South University
-
Contact:
- Yijing He, MD, PhD
- Phone Number: +86-1587481262
- Email: yijinghe@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed according to Classification criteria for Psoriasis vulgaris
- Patients aged 18 to 70 years (to the date of screening)
- Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream
- Phototherapy nearly one months before enrolled
- 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
- Understanding the whole process of the study, voluntary participation and signed the informed consent
Exclusion Criteria:
- Pregnant women, ready to pregnant or lactating women
- Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
- Patients with chronic diarrhea, or peptic ulcer nearly 1 year
- Patients suffering from malignant tumor
- Patients suffering from acute and chronic infectious diseases
- Mental disorders, history of alcohol abuse, drug or other substance abuse
- Other cases which researchers believe that can not enroll
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-arm
intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg
per piece, oral.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease control rate
Time Frame: 8 weeks after the first treatment
|
8 weeks after the first treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiang Chen, MD, Xiangya Hospital of Central South University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 17, 2016
First Submitted That Met QC Criteria
March 21, 2016
First Posted (Estimate)
March 22, 2016
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- 2016 MTX/CSU/PS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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