Pharmacogenomics Study on Treatment of Psoriasis Vulgaris... | NCT02715947

Studies
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

NCT02715947

Sponsor

Central South University

Status

Unknown status

Last Update Posted

Mar 22, 2016Estimated

Enrollment

400Estimated

Phase

Phase 2

Conditions

Psoriasis Vulgaris

Interventions

Methotrexate

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 21, 2016

First Posted Date

Mar 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single-arm	Experimental	intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.	Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug	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.

Measure	Description	Time Frame
disease control rate		8 weeks after the first treatment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yijing He, MD,PhD	Contact	+86-1587481262		yijinghe@gmail.com

Overall Officials

Name	Affiliation	Role
Xiang Chen, MD	Xiangya Hospital of Central South University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiangya Hospital Central South University	Recruiting	Changsha	Hunan	410008	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring