Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis (MTXPG)
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|ClinicalTrials.gov Identifier: NCT02174354|
Recruitment Status : Unknown
Verified June 2014 by King's College London.
Recruitment status was: Enrolling by invitation
First Posted : June 25, 2014
Last Update Posted : June 25, 2014
|Condition or disease|
|Psoriasis Chronic Injury of Liver|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Patients with psoriasis taking methotrexate
- 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
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174354
|King's College London and Guys' and St Thomas' NHS Foundation Trust|
|London, United Kingdom, SE1 9RT|
|Principal Investigator:||Catherine H Smith, MD||Kings College London and Guys and St Thomas' NHS Foundation Trust|