Psoriasis ChronicMTXPGNCT02174354
Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis
An observational study of Psoriasis Chronic and Injury of Liver, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Chronic, Injury of Liver
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics
Who may be able to join
- 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
Who cannot join
- Unable to consent
- Not taking methotrexate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London and Guys' and St Thomas' NHS Foundation Trust
London, London, SE1 9RT
About this study
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.
Read the 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.
- Conditions
- Psoriasis Chronic, Injury of Liver
- Keywords
- Psoriasis, Methotrexate, Methotrexate Polyglutamates, Injury of Liver
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Patients with psoriasis taking methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 3 months to 5 years after first MTX dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriasis ChronicStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine H Smith, MD, Principal investigator, Kings College London and Guys and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174354
- Sponsor's protocol ID
- 11/H0802/7
- Acronym
- MTXPG
- Status last verified
- Jun 2014
- First submitted
- 22 May 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20954192Woolf 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.
PubMed 22309614Stamp 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.
PubMed 19644853
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT02174354
- Acronym / sponsor ID
- MTXPG / 11/H0802/7
- Conditions
- Psoriasis Chronic, Injury of Liver
- Keywords
- Psoriasis, Methotrexate, Methotrexate Polyglutamates, Injury of Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | –Patients with psoriasis taking methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriasis taking methotrexate recruited in outpatient dermatology clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to consent
- Not taking methotrexate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Background: PubMed 20954192Becker 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.
- Background: PubMed 22309614Woolf 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.
- Background: PubMed 19644853Stamp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine H Smith, MD principal investigator
Kings College London and Guys and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Chronic and Injury of Liver, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography (time frame: From 3 months to 5 years after commencing methotrexate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174354, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.