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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02174354

Acronym

MTXPG

Enrollment

350

Registered

2014-06-25

Start date

2011-01-31

Completion date

2018-08-31

Last updated

2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury of Liver, Psoriasis Chronic

Keywords

Psoriasis, Methotrexate, Methotrexate Polyglutamates, Injury of Liver

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
A ROC (Receiver Operating Characteristic) curve will be produced in order to define a therapeutic dose range of MTXPG in psoriasis	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.

Countries

United Kingdom

Outcome results