Clinical Trial: Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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,
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- 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 ]
Information By: Pfizer
Dates:
Date Received: August 18, 2011
Date Started: October 10, 2011
Date Completion: March 8, 2021
Last Updated: March 1, 2017
Last Verified: March 2017