NCT02248792

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Severe Plaque Type Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Improvement in health related quality of life

    12 weeks

Secondary Outcomes (1)

  • comparison of improvement in health related quality of life between Group A and Group B

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Methotrexate 10mg orally once weekly

Drug: Methotrexate

Group B

ACTIVE COMPARATOR

Methotrexate 25mg orally once weekly

Drug: Methotrexate

Interventions

MethotrexateDRUG
Group AGroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narayana Med College and Hospital

Nellore, Andhra Pradesh, 524003, India

RECRUITING

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • C V Krishna, MD

    Narayana Medical college and hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

C V Krishna, MD

CONTACT

+91-0413-2655961vijay_postgradmed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
C V Krishna

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 25, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2015

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

IN(1)