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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

NCT01421069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-11-14

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-10
Primary Completion
2021-02-04
Completion
2021-02-04

Countries

  • Australia
  • Belgium
  • Colombia
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421069 on ClinicalTrials.gov