Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 22, 2016
December 1, 2015
2 years
March 17, 2016
March 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease control rate
8 weeks after the first treatment
Study Arms (1)
single-arm
EXPERIMENTALintervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Chen, MD
Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 22, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 22, 2016
Record last verified: 2015-12