| - candidate number | 2372 |
| - NTR Number | NTR844 |
| - ISRCTN | ISRCTN13524271 |
| - Date ISRCTN created | 22-jan-2007 |
| - date ISRCTN requested | 12-jan-2007 |
| - Date Registered NTR | 14-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Prevention of MTX induced psychological intolerance in children with Juvenile Idiopathic arthritis. |
| - Scientific Title | Phase III effectiveness multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care. |
| - ACRONYM | Gastrointestinal side effects of MTX in patients with JIA |
| - hypothesis | 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). |
| - Healt Condition(s) or Problem(s) studied | Juvenile idiopathic arthritis (JIA) |
| - Inclusion criteria | 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. |
| - Exclusion criteria | 1. MTX parenteral; 2. Other diagnosis; 3. Steroid usage (more than 0.2mg/kg/day); 4. Other MTX related side effects. |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Not applicable |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-mrt-2010 |
| - Target number of participants | 130 |
| - Interventions | 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). |
| - Primary outcome | 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 | 1. JIA disease activity parameters (PRINTO core set criteria);. 2. Metabolomics and folate/homocysteine/adenosine metabolites; 3. Inflammation parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies); 4. MTX related cytopenias. Measured: 0, 3, 6 and 12 months. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Dr. MD., PhD. N. Wulffraat |
| - CONTACT for SCIENTIFIC QUERIES | Dr. MD., PhD. N. Wulffraat |
| - Sponsor/Initiator | University Medical Center Utrecht (UMCU), Department of Pediatrics |
| - Funding (Source(s) of Monetary or Material Support) | Medac, Pharmachmie |
| - Publications | pilot study submitted to Clin Exp Rheumatology |
| - Brief 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. 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. |
| - Main changes (audit trail) | |
| - RECORD | 14-dec-2006 - 23-jan-2007 |
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