Modulating regulatory T cell function in Juvenile Idiopathic Arthritis with Vitamin B3 (nicotinamide): a phase I/II trial focusing on safety and feasibility aspects in children with JIA.
- Conditions
- Juvenile idiopathic arthritisjuvenile rheumatoid arthritis10003816
- Registration Number
- NL-OMON45620
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 45
- 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).
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In this phase II trial essential information will be gained on safety,<br /><br>feasibility and tolerability of NAM as an additional treatment in JIA patients. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Additionally, PK/PD data will we obtained which can be used to develop an<br /><br>optimal dosing scheme for a future phase III clinical trial. Next, preliminary<br /><br>data on the effect of NAM on the function of regulatory T cells will be<br /><br>acquired. </p><br>