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

NCT02174354 | Unknown DMC

• 1 other identifier: 11/H0802/7
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Chronic; Injury of Liver

Keywords

Psoriasis; Methotrexate; Methotrexate Polyglutamates; Injury of Liver

Outcome Measures

Primary Outcomes (1)

• Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography

  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

  From 3 months to 5 years after commencing methotrexate

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (1)

Psoriasis

Patients with psoriasis taking methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics

You may qualify if:

• 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

You may not qualify if:

• Unable to consent
• Not taking methotrexate

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

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

London, London, SE1 9RT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 20954192 BACKGROUND

• 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.

  PMID: 22309614 BACKGROUND

• 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.

  PMID: 19644853 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Longitudinal study design. Serum samples will be retained with consent.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Catherine H Smith, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 25, 2014
• Study Start: January 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

GB (1)