Overview

This trial is active, not recruiting.

Condition juvenile idiopahtic arthritis
Treatment etanercept
Phase phase 3
Sponsor Pfizer
Start date October 2011
End date March 2021
Trial size 109 participants
Trial identifier NCT01421069, 0881A1-3342, 2010-023802-10, B1801023

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
Occurrence of malignancy
time frame: up to 8 years

Secondary Outcomes

Measure
Occurrence of withdrawals from investigational product
time frame: up to 8 years
Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale
time frame: up to 8 years
Patient/Parent Global Assessment on a 21-circle VAS
time frame: up to 8 years
C-reative protein
time frame: up to 8 years
Childhood Health Assessment Questionnaire (CHAQ) for subjects less than 18 years of age; Health Assessment Questionnaire (HAQ) for subjects greater than or equal to 18 years of age.
time frame: up to 8 years
ACR Pediatric 30, 50, 70, 90, and 100
time frame: up to 8 years
Individual components of the ACR Pediatric Assessments
time frame: up to 8 years
Pain Assessment on a 21-circle VAS
time frame: up to 8 years
Duration of morning stiffness in minutes
time frame: up to 8 years
Clinically inactive disease defined as follows per Wallace Criteria
time frame: up to 8 years
The Juvenile Arthritis Disease Activity Score (JADAS)
time frame: up to 8 years
Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only)
time frame: up to 8 years
Bath Ankylosing Spondylitis Metrology Index
time frame: up to 8 years
Body Surface Area (PsA subjects only)
time frame: up to 8 years
Physician Global Assessment of Psoriasis (PsA subjects only)
time frame: up to 8 years

Eligibility Criteria

Male or female participants from 2 years up to 30 years old.

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.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.