60
Participants
Start Date
May 31, 2003
Primary Completion Date
November 30, 2007
Study Completion Date
December 31, 2013
Infliximab plus methotrexate
IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
Combination of DMARDs
IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly, SSZ 40mg/kg up to 2000mg daily, HCQ 5mg/kg daily. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
Methotrexate alone
Oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
Rheumatism Foundation Hospital, Heinola
Hospital for Children and Adolescents, Helsinki
Kuopio University Hospital, Kuopio
Oulu University Central Hospital, Oulu
Tampere University Hospital, Tampere
Turku University Hospital, Turku
Foundation for Paediatric Research, Finland
OTHER
Päivikki and Sakari Sohlberg Foundation, Finland
OTHER
Rheumatism Foundation Hospital
OTHER
Scandinavian Rheumatology Research Foundation
UNKNOWN
Paijat-Hame Hospital District
OTHER
Helsinki University Central Hospital
OTHER