Prevention of methotrexate-induced psychological intolerance in children with juvenile idiopathic arthritis
| ISRCTN | ISRCTN13524271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13524271 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr N Wulffraat
Scientific
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
| Study design | Randomised parallel-group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Prevention of methotrexate-induced psychological intolerance in children with juvenile idiopathic arthritis |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | 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. |
| Secondary outcome measures | 1. JIA disease activity parameters (Pediatric Rheumatology InterNational Trials Organisation [PRINTO] core set criteria) 2. Metabolomics and folate/homocysteine/adenosine metabolites 3. Inflammation parameters (Erythrocyte Sedimentation Rate [ESR], C-Reactive Protein [CRP], cytokine profiles, T regulatory [T-regs] cells, Measles, Mumps, Rubella [MMR] antibodies) 4. MTX related cytopenias Measured: 0, 3, 6 and 12 months. |
| Overall study start date | 01/03/2007 |
| Overall study end date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 130 |
| Participant 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 |
| Participant exclusion criteria | 1. MTX parenteral 2. Other diagnosis 3. Steroid usage (more than 0.2 mg/kg/day) 4. Other MTX related side effects |
| Recruitment start date | 01/03/2007 |
| Recruitment end date | 01/03/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Pediatrics
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Industry
Pharmachemie (The Netherlands)
No information available
Medac (The Netherlands)
No information available
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 | 18/02/2015 | Yes | No |
