Dose finding study of Sarilumab in children with pcJIA
Research type
Research Study
Full title
An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase
IRAS ID
199311
Contact name
Muthana Al Obaidi
Contact email
Sponsor organisation
sanofi-aventis recherche & développement
Eudract number
2015-003999-79
Duration of Study in the UK
2 years, 11 months, 3 days
Research summary
The aim of this study is to find the dose of Sarilumab required to treat children with polyarticular-course juvenile idiopathic arthritis (pcJIA).
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood, by definition being arthritis of unknown cause with onset before 16 years. pcJIA is a subtype of JIA affecting at least 5 joints with onset before 16 years. Both large and small joints are involved and sometimes it is accompanied by a low grade fever. There are two different forms of pcJIA characterised by the presence of Rheumatoid Factor. RF positive is the least common of the two, and RF negative a more common form. Oligoarticular extended rheumatoid arthritis will also be evaluated under the umbrella of pcJIA due to its similarity.
Interleukin-6 is a cytokine in the body, which in large quantities causes inflammation and joint destruction. Preventing IL-6 from binding to its receptor with a drug such as tociluzumab, reduces it action and therefore, the inflammation and joint destruction is reduced. Sarilumab has a very similar action to tociluzumab and has been demonstrated as an effective treatment in adult rheumatoid arthritis.
The body size and weight variation is much greater in children than adults; therefore adjusted doses are needed in children of different weights. For this population of patients 3 doses of sarilumab will be tested in order to determine the appropriate dose.
There are 2 phases in this study, a dose-finding phase over a 12 week period and an extension phase up to 92 weeks, followed by a 6 week follow up period. Approximately 36 patients aged 2 to 17 will be recruited and divided into 2 groups depending upon their weight. Each weight group will be split into 3 groups and each patient will receive different doses which have been calculated carefully.REC name
London - South East Research Ethics Committee
REC reference
16/LO/0814
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion