Original Primary Outcome: American College of Rheumatology (ACR) Pediatric (Pedi) 30 [ Time Frame: 12 weeks ]

Current Secondary Outcome:

• Percentage of Participants With an ACR Pedi 30 Response [ Time Frame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
• Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
• Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
• Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
• Percentage of Participants With an ACR Pedi 50 Response [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
• Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
• Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
• Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
• Percentage of Participants With an ACR Pedi 70 Response [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]
  ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at
  
  

  Original Secondary Outcome:

  • ACR Pedi 50, 70, 90, and 100 [ Time Frame: 96 weeks ]
  • PGA [ Time Frame: Various timepoints up to week 96, or upon early withdrawal ]
  • Patient/Parent Global Assessment [ Time Frame: 96 weeks ]
  • CHAQ [ Time Frame: 96 weeks ]
  • Active Joints [ Time Frame: 96 weeks ]
  • Joints with Limitation of Motion [ Time Frame: 96 weeks ]
  • CRP [ Time Frame: 96 weeks ]
  • Pain Assessment [ Time Frame: 96 weeks ]
  • Duration of Morning Stiffness [ Time Frame: 96 weeks ]
  • Disease Status [ Time Frame: 96 weeks ]
  • Tender Entheseal Assessment [ Time Frame: 96 weeks ]
  • PGA of Psoriasis and BSA [ Time Frame: 96 weeks ]

  
  
  Information By: Pfizer
  

  Dates:
  Date Received: August 13, 2009
  Date Started: September 2009
  Date Completion:
  Last Updated: May 29, 2014
  Last Verified: May 2014
  

  

  Join Millions

  Sign Up For One Of Our
  Newsletters

  Email

  Sign Up