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

NCT ID: NCT02174354

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Psoriasis Chronic Injury of Liver

Study Design

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Observational Model Type

COHORT

Study Groups

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Psoriasis

Patients with psoriasis taking methotrexate

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine H Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Kings College London and Guys and St Thomas' NHS Foundation Trust

Locations

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King's College London and Guys' and St Thomas' NHS Foundation Trust

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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Becker ML, Gaedigk R, van Haandel L, Thomas B, Lasky A, Hoeltzel M, Dai H, Stobaugh J, Leeder JS. The effect of genotype on methotrexate polyglutamate variability in juvenile idiopathic arthritis and association with drug response. Arthritis Rheum. 2011 Jan;63(1):276-85. doi: 10.1002/art.30080.

Reference Type BACKGROUND
PMID: 20954192 (View on PubMed)

Woolf RT, West SL, Arenas-Hernandez M, Hare N, Peters van Ton AM, Lewis CM, Marinaki AM, Barker JN, Smith CH. Methotrexate polyglutamates as a marker of patient compliance and clinical response in psoriasis: a single-centre prospective study. Br J Dermatol. 2012 Jul;167(1):165-73. doi: 10.1111/j.1365-2133.2012.10881.x.

Reference Type BACKGROUND
PMID: 22309614 (View on PubMed)

Stamp LK, O'Donnell JL, Chapman PT, Zhang M, Frampton C, James J, Barclay ML. Determinants of red blood cell methotrexate polyglutamate concentrations in rheumatoid arthritis patients receiving long-term methotrexate treatment. Arthritis Rheum. 2009 Aug;60(8):2248-56. doi: 10.1002/art.24653.

Reference Type BACKGROUND
PMID: 19644853 (View on PubMed)

Other Identifiers

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11/H0802/7

Identifier Type: -

Identifier Source: org_study_id

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