NP25737 PK & Safety Study of TCZ in patients <2 years with active sJIA
Research type
Research Study
Full title
A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)
IRAS ID
174966
Contact name
Gavin Cleary
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2015-000435-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
Systemic Juvenile Idiopathic Arthritis (sJIA) occurs in young children. The age of presentation has a broad peak between 0-5 years.
To date, Tocilizumab (TCZ) has been studied in children with sJIA who were greater than or at the age of 2 years. Tocilizumab (TCZ) has been approved by the health authorities, given alone or in combination with methotrexate, for the treatment of active sJIA in children ages 2 years and older. We wish to perform this study to assess the pharmacokinetic (PK) properties of TCZ in children less than age 2, and is in accordance with a post marketing commitment with the FDA.
Children < 2 years of age with a diagnosis of sJIA who have had sJIA symptoms for at least 1 month at screening and whose sJIA is uncontrolled despite treatments with non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (CS) will be invited to take part in this study.
For each child the study will last up to 21 weeks, from screening to follow up (3 weeks screening, 12 weeks treatment, and 6 weeks follow-up). There is also the option to continue TCZ treatment in an optional extension period for 52 weeks from starting the study or up to 2 years old whichever is longer.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0573
Date of REC Opinion
18 Aug 2015
REC opinion
Favourable Opinion