Condition category
Musculoskeletal Diseases
Date applied
20/10/2011
Date assigned
02/12/2011
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Abdel Qader Al Bawab

ORCID ID

Contact details

Main Campus
University Road
Belfast
BT7 1NN
United Kingdom
-
aalbawab02@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11019

Study information

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

Acronym

Study hypothesis

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

Office of Research Ethics Committees of Northern Ireland, First MREC approval date 01/10/2011, ref: 10/NIR03/33

Study design

Non-randomised observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2011

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

Do not meet the above inclusion criteria or if patients (or their parents/ guardians) do not wish to particpate in the research

Recruitment start date

01/04/2011

Recruitment end date

01/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Queen's University of Belfast
Belfast
BT7 1NN
United Kingdom

Sponsor information

Organisation

Arthritis Research UK (UK)

Sponsor details

ARC Epidemiology Unit
The Queen's University of Belfast
University Road
Belfast
BT97 1NN
United Kingdom

Sponsor type

Charity

Website

http://www.arthritisresearchuk.org/

Funders

Funder type

Charity

Funder name

Arthritis Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26493320

Publication citations

Additional files

Editorial Notes