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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 (C-VIEW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03020992
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : December 31, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis (axSpA) Anterior Uveitis (AU) Drug: Certolizumab Pegol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Anterior Uveitis (C-VIEW)
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Certolizumab Pegol
Subjects will receive a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every two Weeks
Drug: Certolizumab Pegol
  • pharmaceutical form: solution for infusion in prefilled syringe
  • concentration: 200 mg/mL
  • route of administration: subcutaneous
Other Names:
  • Cimzia
  • CZP
  • CDP870




Primary Outcome Measures :
  1. 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 ]
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.


Secondary Outcome Measures :
  1. Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants 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 ]
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.

  2. Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants 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 ]
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.

  3. Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants 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 ]
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.

  4. Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants 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 ]
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.

  5. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    The ASDAS was calculated as the sum of the following:

    0.121 × Back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result) 0.058 × Duration of morning stiffness (BASDAI Question 6 result) 0.110 × Patient's Global Assessment of Disease Activity (PtGADA) 0.073 × Peripheral pain/swelling (BASDAI Question 3 result) 0.579 × (natural logarithm (C-Reactive Protein (CRP) [mg/L] + 1)) Back pain, PtGADA, duration of morning stiffness, and peripheral pain/swelling are all assessed on a numerical scale (0 to 10 units).

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

    There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as 'below the limit of quantification' (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636.


  6. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    The ASDAS was calculated as the sum of the following:

    0.121 × Back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result) 0.058 × Duration of morning stiffness (BASDAI Question 6 result) 0.110 × Patient's Global Assessment of Disease Activity (PtGADA) 0.073 × Peripheral pain/swelling (BASDAI Question 3 result) 0.579 × (natural logarithm (C-Reactive Protein (CRP) [mg/L] + 1)) Back pain, PtGADA, duration of morning stiffness, and peripheral pain/swelling are all assessed on a numerical scale (0 to 10 units).

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

    There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as 'below the limit of quantification' (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636.


  7. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    The BASDAI is a validated self-reported instrument which consists of 6 horizontal Numeric Rating Scales (NRSs), each with 10 units to measure the severity of the 5 major symptoms: fatigue, spinal pain, peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 sum score is divided by 5 to give a final BASDAI score between 0 and 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  8. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    The BASDAI is a validated self-reported instrument which consists of 6 horizontal Numeric Rating Scales (NRSs), each with 10 units to measure the severity of the 5 major symptoms: fatigue, spinal pain, peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 sum score is divided by 5 to give a final BASDAI score between 0 and 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  9. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48 [ Time Frame: Week 48 ]

    The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  10. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96 [ Time Frame: Week 96 ]

    The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  11. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48 [ Time Frame: Week 48 ]

    The ASAS criteria for 40 % improvement were defined as relative improvements of at least 40 %, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains below and no worsening at all in the remaining domain:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  12. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96 [ Time Frame: Week 96 ]

    The ASAS criteria for 40 % improvement were defined as relative improvements of at least 40 %, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains below and no worsening at all in the remaining domain:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  13. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48 [ Time Frame: Week 48 ]

    The ASAS 5/6 response is defined as at least 20 % improvement in 5 of 6 domains, including spinal mobility (lateral spinal flexion) and C-Reactive Protein (CRP) as more objective measures.

    As the BASMI was not collected, and there was no alternative measure of spinal mobility available in the study data, the complete component for spinal mobility was missing. Therefore the ASAS 5/6 response criterion cannot be calculated, and the analysis of the secondary efficacy variable ASAS 5/6 had to be dropped.


  14. Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96 [ Time Frame: Week 96 ]

    The ASAS 5/6 response is defined as at least 20 % improvement in 5 of 6 domains, including spinal mobility (lateral spinal flexion) and C-Reactive Protein (CRP) as more objective measures.

    As the BASMI was not collected, and there was no alternative measure of spinal mobility available in the study data, the complete component for spinal mobility was missing. Therefore the ASAS 5/6 response criterion cannot be calculated, and the analysis of the secondary efficacy variable ASAS 5/6 had to be dropped.


  15. Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48 [ Time Frame: Week 48 ]

    The ASAS PR response is defined as a score of ≤2 units on a 0 to 10 unit scale in all of the 4 following domains:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  16. Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 96 [ Time Frame: Week 96 ]

    The ASAS PR response is defined as a score of ≤2 units on a 0 to 10 unit scale in all of the 4 following domains:

    • Patient's Global Assessment of Disease Activity (PtGADA)
    • Pain assessment (the total spinal pain Numeric Rating Scale score)
    • Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
    • Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)

  17. Change From Baseline in Tender Joint Count (44 Joint Count) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional:

    • Upper body (4) - bilateral sternoclavicular and acromioclavicular joints
    • Upper extremity (26) - bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V
    • Lower extremity (14) - bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

  18. Change From Baseline in Tender Joint Count (44 Joint Count) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional:

    • Upper body (4) - bilateral sternoclavicular and acromioclavicular joints
    • Upper extremity (26) - bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V
    • Lower extremity (14) - bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

  19. Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional:

    • Upper body (4) - bilateral sternoclavicular and acromioclavicular joints
    • Upper extremity (26) - bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V
    • Lower extremity (14) - bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

  20. Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional:

    • Upper body (4) - bilateral sternoclavicular and acromioclavicular joints
    • Upper extremity (26) - bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V
    • Lower extremity (14) - bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

  21. Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    The Investigator assessed the overall status of the participant with respect to the axSpA signs and symptoms and the functional capacity of the participant using a Visual Analog Scale (VAS) where 0 is "very good, asymptomatic and no limitation of normal activities" and 100 is "very poor, very severe symptoms that are intolerable, and the inability to carry out all normal activities." This assessment by the Investigator should be made without any knowledge of the Patient's Global Assessment of Disease Activity (PtGADA).

    Total score ranges from 0 to 100, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  22. Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    The Investigator assessed the overall status of the participant with respect to the axSpA signs and symptoms and the functional capacity of the participant using a Visual Analog Scale (VAS) where 0 is "very good, asymptomatic and no limitation of normal activities" and 100 is "very poor, very severe symptoms that are intolerable, and the inability to carry out all normal activities." This assessment by the Investigator should be made without any knowledge of the Patient's Global Assessment of Disease Activity (PtGADA).

    Total score ranges from 0 to 100, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  23. Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48 [ Time Frame: From Baseline to Week 48 ]

    For the PtGADA questionnaire, participants scored their global assessment of their disease activity in response to the question "How active was your spondylitis on average during the last week?" using a Numeric Rating Scale (NRS) where 0 was "not active" and 10 was "very active".

    Total score ranges from 0 to 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  24. Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96 [ Time Frame: From Baseline to Week 96 ]

    For the PtGADA questionnaire, participants scored their global assessment of their disease activity in response to the question "How active was your spondylitis on average during the last week?" using a Numeric Rating Scale (NRS) where 0 was "not active" and 10 was "very active".

    Total score ranges from 0 to 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  25. Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 48 ]

    The total spinal pain was assessed with the question 'How much pain of your spine due to spondylitis do you have?' using a Numeric Rating Scale (NRS) where 0 was 'No pain' and 10 was 'Most severe pain'. Usually, a 10 % difference (ie, a 1 point difference on a Numeric Rating Scale (NRS) ranging from 0 to 10) is considered the minimal clinically important difference used to interpret scores (Dworkin et al, 2008).

    Total score ranges from 0 to 10, with lower scores indicating a worse outcome. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  26. Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS) [ Time Frame: From Baseline to Week 96 ]

    The total spinal pain was assessed with the question 'How much pain of your spine due to spondylitis do you have?' using a Numeric Rating Scale (NRS) where 0 was 'No pain' and 10 was 'Most severe pain'. Usually, a 10 % difference (ie, a 1 point difference on a Numeric Rating Scale (NRS) ranging from 0 to 10) is considered the minimal clinically important difference used to interpret scores (Dworkin et al, 2008).

    Total score ranges from 0 to 10, with lower scores indicating a worse outcome. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  27. Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 48 ]

    The BASFI is a validated disease-specific instrument for assessing physical function (van Tubergen et al, 2015; Calin et al, 1994; van der Heijde et al, 2005).

    The BASFI comprises 10 items relating to the past week. The Numeric Rating Scale (NRS) version was used for the answering options of each item on a scale of 0 ("Easy") to 10 ("Impossible") (van Tubergen et al, 2002). The BASFI score is the mean of the 10 items such that the total score ranges from 0 to 10, with lower scores indicating better physical function.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  28. Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: From Baseline to Week 96 ]

    The BASFI is a validated disease-specific instrument for assessing physical function (van Tubergen et al, 2015; Calin et al, 1994; van der Heijde et al, 2005).

    The BASFI comprises 10 items relating to the past week. The Numeric Rating Scale (NRS) version was used for the answering options of each item on a scale of 0 ("Easy") to 10 ("Impossible") (van Tubergen et al, 2002). The BASFI score is the mean of the 10 items such that the total score ranges from 0 to 10, with lower scores indicating better physical function.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  29. 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 ]

    The BASDAI is a validated self-reported instrument which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration for each disease activity, respectively) over the last week. The mean of the 2 BASDAI questions related to morning stiffness (questions 5 and 6) ranged from 0 to 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  30. Change From Baseline to Week 96 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 96 ]

    The BASDAI is a validated self-reported instrument which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration for each disease activity, respectively) over the last week. The mean of the 2 BASDAI questions related to morning stiffness (questions 5 and 6) ranged from 0 to 10, with lower scores indicating lower disease activity.

    The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.


  31. Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study [ Time Frame: From Baseline up to the Safety Follow-up Visit (up to Week 104) ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria
  • Subjects must have active disease at Screening as defined by
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
  • Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)
  • Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) > upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
  • Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator
  • Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline

Exclusion Criteria:

  • Other inflammatory arthritis
  • Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA)
  • Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA
  • Any condition or complicating factor that may interfere with the AU assessment
  • Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device
  • Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit
  • Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit
  • Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit
  • Cyclophosphamide within 30 days prior to the Baseline Visit
  • Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit
  • Intravitreal anti-vascular endothelial growth factor (VEGF) therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020992


Locations
Show Show 23 study locations
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
Layout table for investigator information
Study Director: UCB Cares 001 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Study Protocol  [PDF] January 22, 2020
Statistical Analysis Plan  [PDF] February 21, 2020

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT03020992    
Other Study ID Numbers: AS0007
2016-000343-14 ( EudraCT Number )
First Posted: January 13, 2017    Key Record Dates
Results First Posted: December 31, 2020
Last Update Posted: February 9, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Axial Spondyloarthritis
axSpA
Anterior Uveitis
Certolizumab Pegol
Cimzia
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylarthritis
Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Panuveitis
Iris Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents