Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis (MTXPG)

June 24, 2014 updated by: King's College London
Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including psoriasis, where it is the recommended first-line systemic therapy in moderate-to-severe disease. Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and a significant number experience side effects that may include deranged liver enzymes. There is currently no validated test to predict how patients with psoriasis will respond to MTX, in terms of disease outcome and/or toxicity, or to guide dose escalation in this group.

Study Overview

Status

Unknown

Conditions

Detailed Description

Data for this study is drawn from the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort. This is a multi-centre, prospective, cohort study to establish clinically relevant biomarkers and pharmacogenetic markers of systemic treatment outcomes in patients with severe psoriasis.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • King's College London and Guys' and St Thomas' NHS Foundation Trust

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics

Description

Inclusion Criteria:

  • Patients with psoriasis
  • Taking oral or subcutaneous methotrexate
  • Measurement of methotrexate polyglutamates on at least one occasion during therapy.
  • Patients who have given written informed consent

Exclusion Criteria:

  • Unable to consent
  • Not taking methotrexate

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

Cohorts and Interventions

Group / Cohort
Psoriasis
Patients with psoriasis taking methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography
Time Frame: From 3 months to 5 years after commencing methotrexate
To determine if there is a correlation between methotrexate polyglutamate concentrations and clinical response measured by Psoriasis Area Severity Index( PASI) in patients on methotrexate monotherapy with psoriasis. This will consider potential confounding factors, including age, gender and dose of MTX
From 3 months to 5 years after commencing methotrexate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine transaminase (ALT) and Full blood count (FBC) will be used to measure toxicity to methotrexate
Time Frame: 3 months to 5 years after first MTX dose
To determine if there is an association between MTXPG levels and evidence of hepatotoxicity in patients with psoriasis taking either (1) methotrexate alone or (2) methotrexate in combination with another systemic drug. Evidence of hepatotoxicity will be determined by the use of current gold standard tests.
3 months to 5 years after first MTX dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
A ROC (Receiver Operating Characteristic) curve will be produced in order to define a therapeutic dose range of MTXPG in psoriasis
Time Frame: 3 months to 5 years after first dose of methotrexate
If a positive correlation is identified between MTXPG levels and clinical response we aim to define a therapeutic dose range of MTXPG.
3 months to 5 years after first dose of methotrexate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Catherine H Smith, MD, Kings College London and Guys and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (ESTIMATE)

June 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/H0802/7

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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