Quality of Life of Patients With Psoriasis Treated With M... | NCT02248792

Studies
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.

NCT02248792

Sponsor

Narayana Medical College & Hospital

Status

Unknown status

Last Update Posted

Sep 25, 2014Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Severe Plaque Type Psoriasis

Interventions

Methotrexate

Countries

India

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

Sep 2014

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

Nov 2013

Primary Completion Date

Jan 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Sep 22, 2014

First Posted Date

Sep 25, 2014Estimated

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

Sep 22, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Methotrexate 10mg orally once weekly	Drug: Methotrexate
Group B	Active Comparator	Methotrexate 25mg orally once weekly	Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug		Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in health related quality of life		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
comparison of improvement in health related quality of life between Group A and Group B		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) -

Exclusion Criteria:

Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
C V Krishna, MD	Contact	+91-0413-2655961		vijay_postgradmed@yahoo.com

Overall Officials

Name	Affiliation	Role
C V Krishna, MD	Narayana Medical college and hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Narayana Med College and Hospital	Recruiting	Nellore	Andhra Pradesh	524003	India

Intervention Browse Module

MeSH Terms

ID	Term
D008727	Methotrexate

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided