Use of dried blood spots to measure methotrexate levels and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM)
| ISRCTN | ISRCTN93945409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93945409 |
| Secondary identifying numbers | 11019 |
- Submission date
- 20/10/2011
- Registration date
- 02/12/2011
- Last edited
- 26/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Methotrexate is an important drug in treating children with rheumatic disorders such as juvenile idiopathic arthritis (joint inflammation) and juvenile dermatomyositis (skin rash and muscle inflammation). Finger prick dried blood spot samples is the technique widely used in newborns for diagnosing diseases at birth. It requires collection of a few drops of blood on a card which can then be posted to a central laboratory and is very well established. We aim to develop a method for determining methotrexate levels in dried blood spot samples. This method could be used to determine patients have difficulties in absorbing methotrexate, their response to long-term methotrexate treatment, their adherence with prescribed treatment. Dried blood spot sampling is easy to perform and requires very small volumes of blood (a few drops of blood from a simple finger prick), potentially allowing parents to take samples at home, for example, to assist in the monitoring of their child. In addition, such samples are easy to store and transport, without special conditions. The method will also facilitate more research with methotrexate, which will benefit future patients.
Who can participate?
Children aged 4-16 years diagnosed with either juvenile idiopathic arthritis or juvenile dermatomyositis and prescribed methotrexate for at least 2 months.
What does the study involve?
Not provided at time of registration.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The Royal Liverpool Children's Hospital (Liverpool), Musgrave Park Hospital (Belfast) and the University College London (UCL) Institute of Child Health / Great Ormond Street Hospital for Children (GOSH) (London) (UK).
When is study starting and how long is it expected to run for?
April 2011 to April 2012.
Who is funding the study?
Arthritis Research UK.
Who is the main contact?
Abdel Qader Al Bawab
aalbawab02@qub.ac.uk
Contact information
Scientific
Main Campus
University Road
Belfast
BT7 1NN
United Kingdom
| aalbawab02@qub.ac.uk |
Study information
| Study design | Non-randomised observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Use of dried blood spots to measure methotrexate levels and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM): an observational study |
| Study objectives | Use of dried blood spots to measure methotrexate and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM). |
| Ethics approval(s) | Office of Research Ethics Committees of Northern Ireland, First MREC approval date 01/10/2011, ref: 10/NIR03/33 |
| Health condition(s) or problem(s) studied | Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM) |
| Intervention | We will test the possibility of developing an analytical method for the determination of methotrexate and its polyglutamate metabolites in dried blood spot samples. We will also be examining the practicality of home sampling in children. |
| Intervention type | Other |
| Primary outcome measure | To determine the possibility of developing an analytical method for the determination of methotrexate and its polyglutamate metabolites in dried blood spot samples |
| Secondary outcome measures | To determine whether home sampling is practical |
| Overall study start date | 01/04/2011 |
| Completion date | 01/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | 1. Children aged 4-16 years diagnosed with either juvenile idiopathic arthritis or juvenile dermatomyositis (confirmed by a consultant) attending the rheumatology clinic at the paediatric rheumatology outpatient clinics at three sites: the Royal Liverpool Children's Hospital (Liverpool), Musgrave Park Hospital (Belfast) and the University College London (UCL) Institute of Child Health / Great Ormond Street Hospital for Children (GOSH) (London) 2. The child is prescribed methotrexate for at least 2 months (oral or subcutaneous) |
| Key exclusion criteria | Do not meet the above inclusion criteria or if patients (or their parents/ guardians) do not wish to particpate in the research |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/04/2012 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
BT7 1NN
United Kingdom
Sponsor information
Charity
ARC Epidemiology Unit
The Queen's University of Belfast
University Road
Belfast
BT97 1NN
United Kingdom
| Website | http://www.arthritisresearchuk.org/ |
|---|---|
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/10/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
