Prevention of methotrexate-induced psychological intolerance in children with juvenile idiopathic arthritis
| ISRCTN | ISRCTN13524271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13524271 |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funders | Pharmachemie (The Netherlands), Medac (The Netherlands) |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 09/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center Utrecht (UMCU)
Department of Pediatric Immunology and Rheumatology
KC 03.063
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)88 75 5 4003 |
|---|---|
| N.Wulffraat@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised parallel-group multicentre trial |
| Secondary study design | Randomised parallel trial |
| Scientific title | Prevention of methotrexate-induced psychological intolerance in children with juvenile idiopathic arthritis |
| Study objectives | The aims of this study are: 1. To explore the incidence of Methotrexate (MTX) related gastro-intestinal in a large cohort of Juvenile Idiopathic Arthritis (JIA) patients 2. 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). |
| Ethics approval(s) | Medical Ethics Committee of the University Medical Center Utrecht and other participating centers for local feasibility, 21/06/2007, ref: 07/053 |
| Health condition(s) or problem(s) studied | Juvenile Idiopathic arthritis (JIA) |
| Intervention | 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) |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure(s) |
1. The number of patients continuing MTX |
| Key secondary outcome measure(s) |
1. JIA disease activity parameters (Pediatric Rheumatology InterNational Trials Organisation [PRINTO] core set criteria) |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 130 |
| Key inclusion criteria | 1. Diagnosis: all subtypes JIA according to International League of Associations for Rheumatology (ILAR) classification 2. Ages 4 to 17 years 3. MTX oral (dosing 10 to 20 mg/m^2/week) 4. Other medication: Non-Steroidal Anti-Inflammatory Drug (NSAID), biologicals (etanercept, infliximab, anakinra) allowed |
| Key exclusion criteria | 1. MTX parenteral 2. Other diagnosis 3. Steroid usage (more than 0.2 mg/kg/day) 4. Other MTX related side effects |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3508 AB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 18/02/2015 | Yes | No |
