The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
JIA is the most common chronic rheumatic disease in children and an important
cause of short-term and long-term disability in children.
Although the etiology and pathogenesis of JIA are still unclear, the same cell
types and underlying mechanisms that play a role in the progression of adult RA
are probably involved.
Some studies have shown that levels of inflammatory cytokines (eg,
interleukin-1 beta [IL 1**, interleukin-6 [IL-6], and TNF*) elevated in adults
with RA are also elevated in the synovial fluid and serum of patients with JIA.
While there are no current data on the use of golimumab in the pediatric
population, there are abundant, relevant data available on the use of golimumab
in the adult population with rheumatic diseases, and on the use of other
anti-TNF agents such as infliximab, entanercept, and adalimumab in both the
adult and pediatric populations with rheumatic diseases.
In studies of golimumab in adult rheumatologic diseases, the types of adverse
events reported have been similar to those reported with established anti-TNF*
agents.
Study objective
The primary objective of this study is to assess the clinical efficacy of SC
administration of golimumab in pediatric subjects (ages 2 to less than 18
years) with JIA manifested by more or equal to 5 joints with active arthritis
despite MTX therapy for more or equal to 3 months (Section 9.2.1.3).
Study design
This is a randomized withdrawal, double-blind, placebo-controlled,
parallel-group, multicenter study of SC golimumab in pediatric subjects with
active JIA despite current treatment with MTX. At least 170 subjects will be
enrolled at Week 0 to ensure that at least 134 subjects are randomized into the
randomized withdrawal portion of the study.
All subjects will receive golimumab untill Week 12. Those who respond well,
will be enrolled to receive the study medication, which is 50/50
golimumab/placebo through to week 48 of the study.
If the subject has a measured arthritic flare up between weeks 16 and 48, the
study doctor can find out which medication was received, and if it was placebo
he/she will be put back on golimumab for the rest of the study.
At week 48, the sponsor will find out which medication was given and if placebo
was given and no improvement the subject will be switched to golumimab.
When the study is unblinded after all subjects have finished Week 48, the
subjects will be getting golimumab until week 144, which is the end of the
treatment period, except when the a subject has responded well on placebo; then
the study will end for this subject.
The child will continue taking MTX as he/she currently takes, along with folic
acid therapy at the dose he/she was on at the start of the study. If the child
has been on a stable dose of corticosteroids or anti-inflammatory medications,
he/she will most likely be able to stay on these during the entire study.
Intervention
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 under sterile conditions.
Subjects will receive 30 mg/m2 golimumab SC injection to a maximum dose of 50
mg. Subjects will also receive commercial MTX weekly at their fixed dose at
time of study entry and commercial folic acid ** 5 mg weekly or folinic acid
(at half the MTX dose) given the day after the MTX dose.
Study burden and risks
Golimumab has recently been demonstrated to be efficacious in adults with RA,
PsA, and AS. Other anti-TNF agents have been effective in the treatment of
pediatric subjects with juvenile idiopathic arthritis.
Allthough it is expected that the subject will benefit from this
studymedication, he/she will still receive the standard treatment as
background therapy.
The set-up and procedures of this study will not put a major burden on the
subject, except for the long duration and frequent visits to the hospital.
Einsteinweg 92
2333 CD Leiden
NL
Einsteinweg 92
2333 CD Leiden
NL
Listed location countries
Age
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
** 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 0 |
| EudraCT | EUCTR2009-015019-42-NL |
| CCMO | NL33704.018.10 |