Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects
Conditions
Interventions
Pharmaceutical Form:
CAS Number: 7413345
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Trade Name: metoject
P
Sponsors
university medical centre utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. diagnosis: all subtypes JIA according to ILAR classification (15). 2. MTX oral (dosing 10-20mg/m2/week) 3. other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. MTX parenteral 2. Other diagnosis 3. Steroid usage (more than 0.2mg/kg/day) 4. Other MTX related side effects: 4a. Abnormal Liver function tests (definitie (1) waarsch verdubbeling uitgangswaarde 4b. Abnormal renal function tests (serum creatinin increasing to twice baseline values) 4c. Cytopenias (see above(1)) 5. History of non-compliance to earlier treatments not related to MTX 6. Patients currently included in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of the current protocol is to describe the follow-up of JIA patients during MTX therapy using validated response criteria for JIA disease activity (PRINTO core set criteria) and validated psychological response criteria for psychological behavioural therapy. In addition, we aim to explore the incidence, mechanisms and treatment options of MTX intolerance. To assess effectiveness of the 3 treatment options of management of MTX related side effects in children with JIA;Secondary Objective: ;Primary end point(s): • The incidence of MTX intolerance. Side effects are defined as o Gastroenterological side effects leading to intolerance: nausea, nausea occurring prior to dosing (anticipatory nausea), abdominal dysconfort before/after MTX or oral ulcers. For these self reported MTX side effects, a patient log (“diary”) will be used weekly to report observed effects. • Primary clinical outcome measures of JIA after 3 and 6 months of treatment. These variables are(13;14): o Functional ability assessment by CHAQ (laatse versie) o Number of active joints (pain/swelling) o Limitation of movement (defined by EPM-ROM scale) o Physician’s global assessment of disease activity on a 10cm VAS o Parent/patient global assessment of disease activity on a 10cm VAS o Parent/patient global assessment of pain on a 10 cm VAS o ESR and CRP • Number of MTX treatment failures, switching to TNF blockade • The incidence of other MTX related side effects | — |
Countries
Germany, Netherlands
Outcome results
None listed