Secukinumab treatment in Juvenile Idiopathic Arthritis
Research type
Research Study
Full title
A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis
IRAS ID
219468
Contact name
Athimalaipet Ramanan
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-003761-26
Duration of Study in the UK
3 years, 7 months, 21 days
Research summary
Juvenile idiopathic arthritis (JIA) represents a heterogeneous group of chronic idiopathic arthritides of at least 6 weeks duration which presents in children less than 16 years of age. These conditions have variable clinical presentations and prognoses, variable age of onset, and are a major cause of morbidity.
There are seven JIA categories of which Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) represent a spondyloarthropathy (SpA) similar to the adult spondyloarthropathies of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) respectively.
Juvenile psoriatic arthritis (JPsA) is an inflammatory arthritis which can present with or without psoriasis skin involvement and accounts for approximately 5 to 10% of the total JIA population.
Enthesitis-related arthritis (ERA) is a clinically heterogeneous group including some who have predominantly enthesitis, enthesitis and arthritis, juvenile ankylosing spondylitis, or inflammatory bowel disease-associated (IBD) arthropathy. ERA accounts for approximately 3%–11% of JIA.
Treatment of these diseases to target controlling the inflammation with NSAIDs (Non-steroidal anti-inflammatory drugs), corticosteroids as intraarticular injections, DMARDs (Disease modifying antirheumatic drugs) and biologic agents either as monotherapy or in combination with other therapies (DMARD and/or NSAID). Successful management requires careful long-term monitoring of disease activity and willingness to adjust treatments as necessary to achieve and maintain the lowest level of disease activity.
The purpose of this study is to demonstrate the efficacy and safety of secukinumab treatment in children ≥2 to <18 years of age with active ERA and JPsA categories of JIA and to demonstrate the sustained efficacy of secukinumab by using a flare prevention design in a double-blind placebo control treatment withdrawal part of the trial. Additionally, this study will evaluate predicted pediatric doses to achieve secukinumab level equivalency of adult 150mg dosing.
The study is looking to recruit approximately 80 patients worldwide into the study with 8 of these from 5 centres in the UK.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0055
Date of REC Opinion
10 Mar 2017
REC opinion
Further Information Favourable Opinion