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)

January 20, 2021 updated by: UCB Biopharma SRL

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • As0007 101
      • Brno, Czechia
        • As0007 103
      • Brno, Czechia
        • As0007 107
      • Ostrava, Czechia
        • As0007 108
      • Pardubice, Czechia
        • As0007 109
      • Praha, Czechia
        • As0007 105
      • Praha 2, Czechia
        • As0007 102
  • Germany
      • Freiburg, Germany
        • As0007 301
      • München, Germany
        • As0007 302
      • Münster, Germany
        • As0007 303
  • Netherlands
      • Amsterdam, Netherlands
        • As0007 401
  • Poland
      • Białystok, Poland
        • As0007 506
      • Lublin, Poland
        • As0007 510
      • Poznań, Poland
        • As0007 509
      • Poznań, Poland
        • As0007 511
      • Toruń, Poland
        • As0007 502
      • Warszawa, Poland
        • As0007 501
      • Warszawa, Poland
        • As0007 505
      • Wrocław, Poland
        • As0007 504
      • Wrocław, Poland
        • As0007 507
      • Wrocław, Poland
        • As0007 508
  • Spain
      • Barcelona, Spain
        • As0007 604
      • Córdoba, Spain
        • As0007 601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the pre-study period and during the Treatment Period up to 96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 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.
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 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.
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

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.
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

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.
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

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.
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

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.
From Baseline to Week 96
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)
Week 48
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)
Week 96
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)
Week 48
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)
Week 96
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.
Week 48
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.
Week 96
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)
Week 48
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)
Week 96
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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
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

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.
From Baseline to Week 48
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.
From Baseline to Week 96
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.
From Baseline up to the Safety Follow-up Visit (up to Week 104)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS0007
  • 2016-000343-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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