The aim of this study is to explore the incidence of MTX related gastro-intestinal in a large cohort of JIA patients. Secondly, we want to investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
number of patients reporting gastrointestinal side effects
Secondary outcome
number of patients stopping MTX
JIA disease activity parameters (PRINTO core set criteria, based on which the
Juvenile Arthritis Disease Activity Score (JADAS) will be calculated).
Metabolomics and folate/homocysteine/adenosine metabolites and Inflammation
parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies), and MTX
related cytopenias
Background summary
MTX is currently the most widely used, effective, safe and cheapest second line
anti-rheumatic drug for the treatment of Juvenile Idiopathic Arthritis (JIA)
and Rheumatoid Arthritis (RA). These advantages have made MTX very successful
with regard to efficacy and safety for the individual patient as well as for
the health care budget.
The downside of MTX is that especially after prolonged use, quite a number of
JIA patients turn intolerant for the drug. This intolerance is characterized by
severe gastrointestinal complaints that sometimes occur even before taking the
drug.
Study objective
The aim of this study is to explore the incidence of MTX related
gastro-intestinal in a large cohort of JIA patients. Secondly, we want to
investigate the effect of psychological behavioural therapy or switch to
parenteral MTX dosing to ameliorate these side effects. In a pilot study such a
behavioural therapy was successful in 7 of 9 JIA patients. These patients could
therefore continue the MTX, and did not need to switch to alternative
medication (often more immunosuppressive, toxic and very expensive).
Secondary objective: to explore experiences of both parents and children
regarding research participation
Study design
Prospective interventional multicenter.
Intervention
Patients will be randomised for a) behavioral therapy plus continuation of oral
MTX; b) switch to parenteral MTX; c) continuation of standard of care plus
anti-emetic drugs.
No randomisation for control groups
Study burden and risks
Behavioural therapy is easy to apply and safe. In the first month it is time
consuming. There are no risks for applying this in children.
The benefit is that we expect that behavioural therapy will ameliorate the
intolerance and prevent switch to parenteral MTX (painfull injections) or
alternative (more immunosuppressive and more expensive) medication.
For the control group that only fill in the questionnaire there is no burden or
risk. It takes 5 minutes to complete this questionnaire
PB 85090
3508AB Utrecht
NL
PB 85090
3508AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
gastrointestinal side effects of MTX in patients with JIA
Pediatric ALL with MTX maintenance treatment
Adults with RA or psoriatic artritis with MTX maintenance treatment
Exclusion criteria
parenteral MTX usage ( page17 protocol)
other causes of MTX toxicity
other diagnosis
failure to comply
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006812-31-NL |
| CCMO | NL15748.041.07 |