Juvenile Idiopathic Arthritis, JIA, jeugdreuma
Conditions
Interventions
Additional nicotinamide treatment with 1,2g/m2/day or 1,8g/m2/day in either 2 or 3 doses a day for the duration of 3 months
Sponsors
UMC Utrecht, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with a diagnosis of oligo-articular or poly-articular JIA with active disease in 1 or multiple joints and an indication for intra-articular corticosteroid injection. - Age between 4 to 18 years - At the moment of inclusion, not on non-biological DMARD (Methotrexate) treatment or on stable DMARD treatment (at least 3 months of stable Methotrexate use).
Exclusion criteria
Exclusion criteria: - no informed consent possible by patient/parents or caregivers - participation in other interventional trials - Treatment with biological DMARD - Recently started treatment with non-biological DMARD (Methotrexate). Defined as treatment for a period less than 3 months. - Use of systemic corticosteroids - Relevant co morbidity: raised liver enzymes (>2x upper limit) and/or evidence of bone marrow failure (pancytopenia based upon full blood count).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, feasibility and tolerability of nicotinamide treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - PK/PD data - to acquire preliminary data on the effect of nicotinamide on the function of regulatory T cells in vivo and in vitro by using surrogate parameters. | — |
Contacts
Public ContactS.J. Vastert
Department of pediatric rheumatology, UMC Utrecht
Outcome results
None listed