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
Bron
Verkorte titel
Aandoening
Patients with JIA (all subtypes) aging 4 to 17 years
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The number of patients continuing MTX;
2. Number of patients reporting gastrointestinal side effects;
3. JIA disease activity parameters.
Measured: 0, 3, 6 and 12 months.
Achtergrond van het onderzoek
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.
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 11 of 20 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).
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.
Doel van het onderzoek
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 11 of 20 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).
Onderzoeksproduct en/of interventie
Patients will be randomised for
1. Behavioral therapy plus continuation of oral MTX (intervention);
2. Switch to parenteral MTX (control)
3. Continuation of standard of care plus anti-emetic drugs (control).
Publiek
Department of Pediatric immunology and rheumatology,
KC 03.063
P.O. Box 85090
N. Wulffraat
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504003
N.Wulffraat@umcutrecht.nl
Wetenschappelijk
Department of Pediatric immunology and rheumatology,
KC 03.063
P.O. Box 85090
N. Wulffraat
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504003
N.Wulffraat@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Diagnosis: all subtypes JIA according to ILAR classification;
2. Ages 4 to 17 years;
3. MTX oral (dosing 10-20mg/m2/week);
4. Other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. MTX parenteral;
2. Other diagnosis;
3. Steroid usage (more than 0.2mg/kg/day);
4. Other MTX related side effects.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL831 |
| NTR-old | NTR844 |
| Ander register | : N/A |
| ISRCTN | ISRCTN13524271 |