CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 109 enrolled
Drug / intervention
etanerceptdrug
Likely dose
etanercept 0.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01421069
NCT01421069Phase 3Completed
CompareCT.gov

AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)

Pfizer·interventional·Posted Aug 22, 2011·Updated Nov 14, 2022

In Brief

A Phase 3 clinical trial evaluating etanercept for Juvenile Idiopahtic Arthritis. Completed, enrolled 109 participants across 35 sites in 19 countries.

Detailed Summary

This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \[extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)\] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopahtic Arthritis
CountriesAustralia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russia, Serbia, Slovakia, Slovenia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2011
Enrollment StartOct 10, 2011
Primary CompletionFeb 4, 2021
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 14.9 years ago

Interventions

etanerceptdrug

Subjects aged \<18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW). Subjects aged greater than or equal to 18 years or \>62 kg will receive etanercept SC at a dose of 50 mg QW.