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, Same as current

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