artritis JIA
Conditions
Interventions
The study will have 1 active treatment group. The test products, golimumab and
placebo, will be prepared by a blinded pharmacist from a prefilled syringe
(PFS) and transferred to a graduated syringe
Sponsors
Centocor Netherlands B.V.
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: * Pediatric subject ages 2 to less than 18 years of age. * Diagnosis must be made per JIA ILAR diagnostic criteria and the onset of disease must have been before the subject*s 16th birthday * Disease duration of at least 6 months before study entry. * May have been previously treated with no more than 1 therapeutic agent targeted at reducing TNF*.
Exclusion criteria
Exclusion criteria: ** Have known allergies, hypersensitivity, or intolerance to golimumab or other immunoglobulins or its excipients * Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration. * Have a past history of macrophage activation syndrome (MAS). * Have received an investigational drug (including vaccines) or used an investigational medical device recently * Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation. * Have other inflammatory disease that might confound the evaluation of benefit from golimumab therapy * Have current side effects related to MTX which would preclude treatment with MTX * Have a history of or ongoing chronic or recurrent infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of subjects who are ACR Ped 30 responders (as defined in Section 9.2.1.3) at Week 16 and do not experience a flare of disease between Week 16 and Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of ACR Ped 30 responders at Week 16 with ACR Ped 30 response at Week 48. 2. The proportion of subjects who are responders at Week 16 and have inactive disease at Week 48. 3. The proportion of subjects, who are responders at Week 16 and are in clinical remission (as defined in Section 9.2.1.3) while on medication for JIA at Week 48. | — |
Countries
Netherlands
Outcome results
None listed