A study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA)

Phase 1

Conditions: Juvenile idiopathic arthritis (JIA)
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2016-003643-10-NL

Lead Sponsor: MC Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

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

- 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - PK/PD data <br>- 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)