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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease
Psoriasis Chronic Injury of Liver

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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Patients with psoriasis taking methotrexate

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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
Longitudinal study design. Serum samples will be retained with consent.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02174354

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United Kingdom
King's College London and Guys' and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
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Principal Investigator: Catherine H Smith, MD Kings College London and Guys and St Thomas' NHS Foundation Trust

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Responsible Party: King's College London Identifier: NCT02174354     History of Changes
Other Study ID Numbers: 11/H0802/7
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by King's College London:
Methotrexate Polyglutamates
Injury of Liver
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors