Primary* To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.Secondary* To assess the long-term safety profile of etanercept.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Occurrence of malignancy.
Secondary outcome
* Occurrence of serious adverse events;
* Occurrence of medically important infections (ie, an infection requiring
hospitalization and /or parenteral [intravenous (IV), intra-muscular (IM)]
anti-infective agents).
Additional Key Secondary Endpoints for Subjects in the Active Treatment Period
* Occurrence of all adverse events, including infections, infections considered
preventable by vaccination, and injection site reactions;
* Occurrence of withdrawals from investigational product due to adverse events;
* Laboratory evaluations;
* Growth parameters;
* Tanner Stage Assessment for selected subjects.
Other Secondary Endpoints for Subjects in the Active Treatment Period
* Physician*s Global Assessment (PGA) of Disease Activity on a 21-circle visual
analogue scale (VAS);
* Patient/Parent Global Assessment on a 21-circle VAS;
* C-reactive protein (CRP).
Health Outcomes Assessment for Subjects in the Active Treatment Period
* Childhood Health Assessment Questionnaire (CHAQ): for subjects aged <18 years
at the time of assessment;
* Health Assessment Questionnaire (HAQ): for subjects aged >18 years at the
time of assessment.
Background summary
Juvenile idiopathic arthritis (JIA) is the most common
autoimmune-autoinflammatory disease in childhood and affects approximately 1 in
1,000 children. Despite advances in diagnosis and treatment options, JIA
remains a chronic condition for most affected children. Etanercept is approved
by both the US Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) to treat pediatric patients with polyarticular JIA aged 4 years
and above, who have had an inadequate response to, or who have proved
intolerant of, methotrexate.
Protocol 0881A1-3338 was designed to assess the clinical benefit and the
long-term safety of etanercept for 2 years in pediatric subjects with extended
oligoarticular JIA, ERA or PsA.
Protocol B1801023 is an 8-year extension study designed to further characterize
the long-term safety profile, malignancy and other serious adverse events, for
those pediatric subjects who received at least one dose of etanercept and
completed 96 weeks of investigational product and/or follow-up in study
0881A1-3338.
Study objective
Primary
* To monitor the occurrence of malignancy in pediatric subjects with extended
oligoarticular JIA, ERA, or PsA.
Secondary
* To assess the long-term safety profile of etanercept.
Study design
This is an open-label, single treatment, multi-center, 8-year extension study.
Intervention
Active treatment period:
* Subjects who completed approximately 96 weeks of active treatment with
investigational product (etanercept) in study 0881A1-3338 and are eligible to
continue investigational product in study B1801023 will enter directly into the
active treatment period. These subjects may continue to receive investigational
product for up to 8 additional years (96 months).
Observational period:
* Subjects who discontinue investigational product prior to completing 96 weeks
of active treatment in study 0881A1-3338 for any reason or who are not eligible
to continue investigational product in study B1801023 will not be permitted to
re-start investigational product in study B1801023 and will enter directly into
the observational period of study B1801023. These subjects will be observed for
up to 8 years (96 months).
* Subjects who participate in the active treatment period of study B1801023 and
subsequently discontinue use of investigational product at any time before
completion of the study will be transferred from the active treatment period to
the observational period, and will be followed in the observational period for
up to a total of 8 years (96 months) from the time of initial entry into study
B1801023. Once a subject enters into the observational period after
discontinuing from the active treatment period, he or she cannot resume
investigational product for the remaining time in the study. Subjects
participating in the observational period of study B1801023 will receive
standard of care including any anti-TNF agents (eg, commercial etanercept)
and/or other biologic agents for treatment of their disease at the discretion
of the investigator.
Study burden and risks
There is over 10 years experience with the product etanercept in adults.
Meanwhile, there is also experience in children, according to both label and
off-label.
In the current study, etanercept is added to existing treatment (treatment arm)
or patients are observed only. The additional load consists of keeping diaries
and more visits to the outpatient clinic, where questionnaires are to be
completed.
235 East 42nd Street
NY 10017
US
235 East 42nd Street
NY 10017
US
Listed location countries
Age
Inclusion criteria
* Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
* Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally authorized representative/guardian) has been informed of all pertinent aspects of the study.;Please see the protocol, section 4.1, for a complete list of inclusion criteria
Exclusion criteria
* Withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
* History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.;Please see the protocol, section 4.2, for a complete list of exclusion criteria
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 |
|---|---|
| EudraCT | EUCTR2010-023802-10-NL |
| ClinicalTrials.gov | NCT01421069 |
| CCMO | NL38158.041.11 |