Juvenile idiopathic arthritis juvenile rheumatoid arthritis
Conditions
Interventions
Additional NAM therapy with 1,2g/m2/day or 1,8g/m2/day in either 2 or 3 doses a
day during 3 months.
Nicotinamide
Vit B 3
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 17 Years
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
Secondary
| Measure | Time frame |
|---|---|
| Additionally, PK/PD data will we obtained which can be used to develop an optimal dosing scheme for a future phase III clinical trial. Next, preliminary data on the effect of NAM on the function of regulatory T cells will be acquired. | — |
Primary
| Measure | Time frame |
|---|---|
| In this phase II trial essential information will be gained on safety, feasibility and tolerability of NAM as an additional treatment in JIA patients. | — |
Countries
The Netherlands
Outcome results
None listed