Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER2)

Pfizer

Status and phase

Completed

Phase 3

Conditions

Juvenile Idiopahtic Arthritis

Treatments

Drug: etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT01421069

0881A1-3342 (Other Identifier)

B1801023

2010-023802-10 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

109 patients

Sex

All

Ages

2 to 30 years old

Volunteers

No Healthy Volunteers

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.