NCT01421069

Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Juvenile Idiopahtic Arthritis

Interventions

Type	Name	Description
DRUG	etanercept	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.

Timeline

• Start date: 2011-10-10
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2011-08-22
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

35 sites across 19 countries: Australia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russia, Serbia, Slovakia, Slovenia, Spain