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

• Conditions: Injury of Liver; Psoriasis Chronic

• Registration Number: NCT02174354
• Lead Sponsor: King's College London

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-05-22
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography	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

Secondary Outcome Measures

Name	Time	Method
Alanine transaminase (ALT) and Full blood count (FBC) will be used to measure toxicity to methotrexate	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.

Trial Locations

Locations (1)

King's College London and Guys' and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom