Juvenile idiopathic arthritis (JIA)
Conditions
Interventions
Product Name: nicotinamide
Product Code: 98-92-0
Pharmaceutical Form: Tablet
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
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). Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: In this phase II trial essential information will be gained on safety, feasibility and tolerability of NAM as an additional treatment in JIA patients. ;Secondary Objective: 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 end point(s): safety, feasibility and tolerability of nicotinamide treatment;Timepoint(s) of evaluation of this end point: 2 weeks, 6 weeks, 3 months and 6 months after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PK/PD data - efficacy; 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. ;Timepoint(s) of evaluation of this end point: 2 weeks, 6 weeks, 3 months and 6 months after start of treatment (time point 6 months only for efficacy outcome) | — |
Countries
Netherlands
Contacts
Public ContactS.J.Vastert
UMC Utrecht
Outcome results
None listed