Clinical Trial: A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects With a History of

Brief Summary: The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU

Detailed Summary:
Sponsor: UCB Biopharma S.P.R.L.

Current Primary Outcome: Number of distinct episodes of anterior uveitis (AU) flares during the Treatment Period [ Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks ]

Original Primary Outcome: Number of distinct episodes of anterior uveitis (AU) flares during the Treatment Period [ Time Frame: During the Treatment Period up to 96 weeks ]

Current Secondary Outcome:

  • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 48 [ Time Frame: During the pre-study period and during the Treatment Period up to 48 weeks ]
  • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 96 [ Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks ]
  • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 48 [ Time Frame: During the pre-study period and during the Treatment Period up to 48 weeks ]
  • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 96 [ Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks ]
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 [ Time Frame: Week 48 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 96 [ Time Frame: Week 96 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 [ Time Frame: Week 48 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 96 [ Time Frame: Week 96 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 48 [ Time Frame: Week 48 ]
  • Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 96 [ Time Frame: Week 96 ]
  • Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 48 [ Time Frame: Week 48 ]
  • Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 96 [ Time Frame: Week 96 ]
  • Change from Baseline in tender joint count (44 joint count) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline in tender joint count (44 joint count) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Change from Baseline in swollen joint count (44 joint count) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline in swollen joint count (44 joint count) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]
  • Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]
  • Change from Baseline in total spinal pain at Week 48 assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline in total spinal pain at Week 96 assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 96 ]
  • Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 48 ]
  • Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 96 ]
  • Change from Baseline to Week 48 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning

    Original Secondary Outcome:

    • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 48 [ Time Frame: During the Treatment Period up to 48 weeks ]
    • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 96 [ Time Frame: During the Treatment Period up to 96 weeks ]
    • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 48 [ Time Frame: During the Treatment Period up to 48 weeks ]
    • Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 96 [ Time Frame: During the Treatment Period up to 96 weeks ]
    • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 [ Time Frame: Week 48 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 96 [ Time Frame: Week 96 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 [ Time Frame: Week 48 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 96 [ Time Frame: Week 96 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 48 [ Time Frame: Week 48 ]
    • Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 96 [ Time Frame: Week 96 ]
    • Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 48 [ Time Frame: Week 48 ]
    • Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 96 [ Time Frame: Week 96 ]
    • Change from Baseline in tender joint count (44 joint count) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline in tender joint count (44 joint count) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Change from Baseline in swollen joint count (44 joint count) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline in swollen joint count (44 joint count) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]
    • Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]
    • Change from Baseline in total spinal pain at Week 48 assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline in total spinal pain at Week 96 assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 96 ]
    • Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 48 ]
    • Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 96 ]
    • Change from Baseline to Week 48 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration [ Time Frame: From Baseline to Week 48 ]
    • Change fr

      Information By: UCB Pharma

      Dates:
      Date Received: January 11, 2017
      Date Started: January 2017
      Date Completion: April 2020
      Last Updated: May 3, 2017
      Last Verified: May 2017