Juvenile idiopathic arthritis (polyarticular) Musculoskeletal Diseases
Conditions
Interventions
IMP: Intravenous methylprednisolone administered over 3 days on a hospital day unit
Comparator: Oral prednisolone taken/administered over 6 weeks at home
The doses, frequency and method of administra
Dose (patient =40 kg): 40 mg
Week of oral prednisolone 2: Dose (patient <40 kg): 0.75 mg/kg per day
Dose (patient =40 kg): 30 mg
Week of oral prednisolone 3: Dose (patient <40 kg): 0.5 mg/kg per day
Dose (patient =40 kg): 20 mg
Week of oral prednisolone 4: Dose (patient <40 kg): 0.375 mg/kg per day
Dose (patient =40 kg): 15 mg
Week of oral prednisolone 5: Dose (patient <40 kg): 0.25 mg/kg per day
Dose (patient =40 kg): 10 mg
Week of oral prednisolone 6: Dose (patient <40 kg): 0.125 mg/kg per day
Dose (patient =40 kg): 5 mg
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be between 1-18 years of age inclusive 2. New onset pcJIA diagnosed by a paediatric rheumatologist (to include polyarticular rheumatoid factor (RF+) positive, polyarticular RF negative, enthesitis-related arthritis, psoriatic arthritis and extended oligo-articular). This includes new diagnosis of JIA with at least 5 joints affected and patients previously categorised as oligoarticular JIA (with 4 joints or less) who have extended to at least 5 joints. 3. Participants are expected to be able to commence allocated treatment within 1 week of randomisation 4. Written, informed consent and where appropriate, assent obtained from participant or their legal representative 5. Participants of child-bearing potential must be willing to abstain from sexual intercourse from consent to their final visit and/or use another acceptable contraception method as described in section 9.10.5 of this protocol
Exclusion criteria
Exclusion criteria: 1. Any contraindication to starting corticosteroids 2. Any contraindication to starting methotrexate 3. Pregnancy 4. Treatment with systemic corticosteroids within 4 weeks preceding screening (includes IV, IA, IM and oral) 5. Treatment with methotrexate within 12 weeks preceding screening 6. Any co-morbidity which in view of the treating clinician makes participation inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome: Disease activity measured using the JADAS10 score at 0 weeks (Baseline) and 6 weeks Primary economic outcomes: 1. Incremental cost per quality-adjusted life year (QALY) gained measured using Resource Use Questionnaires and Patient Level Information and Costing System (PLICS) data at 0 weeks (Baseline), 6 weeks, 12 weeks, 24 weeks and 52 weeks. 2. Resource use, costs and health utilities associated with IV and oral corticosteroids measured using Resource Use Questionnaires and Patient Level Information and Costing System (PLICS) data at 0 weeks (Baseline), 6 weeks, 12 weeks, 24 weeks and 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease activity in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomised to IV methylprednisolone or oral prednisolone measured using the American College of Rheumatology (ACR) Pediatric Response Criteria (30, 50, 70, 90, 100) at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 2. Disease activity in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA), randomised to IV methylprednisolone or oral prednisolone measured using the JADAS (10,27,71) at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 3. Disease activity in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomised to IV methylprednisolone or oral prednisolone measured by JADAS10 cut-off scores at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 4. Pain in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomised to IV methylprednisolone or oral prednisolone measured using the Pain Visual Analogue Scale (Pain VAS) at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 5. Function in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomised to IV methylprednisolone or oral prednisolone measured using the Childhood Health Assessment Questionnaire (CHAQ) at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 6. Health-related Quality of Life (HRQoL) in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomised to IV methylprednisolone or oral prednisolone measured using Child Health Utility 9D Questionnaire (CHU-9D) and CAPTURE-JIA PROM at 0 weeks (baseline), 6 weeks, 12 weeks, 24 weeks, 52 weeks. 7. Requirement for additional treatment for subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) due to failure to respond to IV methylprednisolone or oral prednisolone measured using concomitant medications recorded at 6 weeks, 12 weeks, 24 weeks, 52 weeks. 8. Glucocorticoid toxicity in subjects with polyarticular Juvenile Idiopathic Arthritis (JIA) randomise | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactLaura Whitty
Outcome results
None listed