Overview

Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Status:
Completed

Trial end date:
2021-02-04

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Etanercept

Criteria

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 representative/guardian) has been informed of all
pertinent aspects of the study.

Exclusion Criteria:

Exclusion criteria for subject planning to continue investigational product:

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.