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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
Sponsor:
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date May 22, 2014
First Posted Date June 25, 2014
Last Update Posted Date June 25, 2014
Study Start Date January 2011
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2014)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 24, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis
Official Title Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis
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 Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Longitudinal study design. Serum samples will be retained with consent.
Sampling Method Non-Probability Sample
Study Population Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics
Condition
  • Psoriasis Chronic
  • Injury of Liver
Intervention Not Provided
Study Groups/Cohorts Psoriasis
Patients with psoriasis taking methotrexate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 24, 2014)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02174354
Other Study ID Numbers 11/H0802/7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party King's College London
Study Sponsor King's College London
Collaborators Not Provided
Investigators
Principal Investigator: Catherine H Smith, MD Kings College London and Guys and St Thomas' NHS Foundation Trust
PRS Account King's College London
Verification Date June 2014