A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Phase 3 Terminated 173 enrolled Janssen Research & Development, LLC Schering-Plough · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Timeline

Start: 2010-12
Primary completion: 2013-09
Completion: 2014-05

Outcome

Missed primary endpoint

Stopped: “Trial has failed to meet primary - and major secondary endpoints”

paper At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates PMID 28507219 ↗

Publications

Brunner HI, Ruperto N, Tzaribachev N, Horneff G, Chasnyk VG, Panaviene V, Abud-Mendoza C, Reiff A, Alexeeva E, Rubio-Perez N, Keltsev V, Kingsbury DJ, Del Rocio Maldonado Velazquez M, Nikishina I, Silverman ED, Joos R, Smolewska E, Bandeira M, Minden K, van Royen-Kerkhof A, Emminger W, Foeldvari I, Lauwerys BR, Sztajnbok F, Gilmer KE, Xu Z, Leu JH, Kim L, Lamberth SL, Loza MJ, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018 Jan;77(1):21-29. doi: 10.1136/annrheumdis-2016-210456. Epub 2017 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Golimumab	Monoclonal antibody	30 mg/m2	Subcutaneous
Background	Methotrexate	Small molecule	10 mg/m2	—
Background	Methotrexate	Small molecule	30 mg/m2	—