Axial Spondyloarthritis (axSpA)Phase 4C-VIEWNCT03020992
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
A Phase 4 study testing Certolizumab Pegol in people with Axial Spondyloarthritis (axSpA) and Anterior Uveitis (AU), run by UCB Biopharma SRL at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis (axSpA), Anterior Uveitis (AU)
- What is being tested?
- Certolizumab Pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 21 Dec 2016to 23 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Poland10 sites
As0007 506
Bialystok
As0007 510
Lublin
As0007 509
Poznan
As0007 511
Poznan
As0007 502
Torun
As0007 501
Warsaw
As0007 505
Warsaw
As0007 504
Wroclaw
As0007 507
Wroclaw
As0007 508
Wroclaw
Czechia7 sites
As0007 101
Brno
As0007 103
Brno
As0007 107
Brno
As0007 108
Ostrava
As0007 109
Pardubice
As0007 102
Prague
As0007 105
Prague
Germany3 sites
As0007 301
Freiburg im Breisgau
As0007 302
München
As0007 303
Münster
About this study
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)
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.
- Being tested
- Certolizumab Pegol
- Keywords
- Axial Spondyloarthritis, axSpA, Anterior Uveitis, Certolizumab Pegol, Cimzia
- Medical subject headings
- Axial Spondyloarthritis, Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolDrug
Also called Cimzia, CZP, CDP870
- pharmaceutical form: solution for infusion in prefilled syringe
- concentration: 200 mg/mL
- route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab Pegol | Experimental | 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 Receives: Drug: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
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.
Measured: During the pre-study period and during the Treatment Period up to 96 weeks
Secondary outcomes (31)
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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From Baseline to Week 48
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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.
Measured: From Baseline to Week 96
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: From Baseline to Week 48
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: From Baseline to Week 96
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at 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)
Measured: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at 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)
Measured: Week 96
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at 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)
Measured: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at 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)
Measured: Week 96
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at 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.
Measured: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at 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.
Measured: Week 96
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at 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)
Measured: Week 48
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at 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)
Measured: Week 96
Change From Baseline in Tender Joint Count (44 Joint Count) at 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.
Measured: From Baseline to Week 48
Change From Baseline in Tender Joint Count (44 Joint Count) at 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.
Measured: From Baseline to Week 96
Change From Baseline in Swollen Joint Count (44 Joint Count) at 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.
Measured: From Baseline to Week 48
Change From Baseline in Swollen Joint Count (44 Joint Count) at 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.
Measured: From Baseline to Week 96
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at 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.
Measured: From Baseline to Week 48
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at 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.
Measured: From Baseline to Week 96
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at 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.
Measured: From Baseline to Week 48
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at 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.
Measured: From Baseline to Week 96
Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS)
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.
Measured: From Baseline to Week 48
Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS)
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.
Measured: From Baseline to Week 96
Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Measured: From Baseline to Week 48
Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Measured: 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
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.
Measured: 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
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.
Measured: From Baseline to Week 96
Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study
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.
Measured: From Baseline up to the Safety Follow-up Visit (up to Week 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start21 Dec 2016
- Primary completion4 Dec 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (axSpA)Studies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020992
- Sponsor's protocol ID
- AS0007
- Other IDs
- 2016-000343-14, 2016
- Acronym
- C-VIEW
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2017
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haroon N, Baskurt Z, Chim T, Inman RD, Kumke T, Tham R, Kim M, van der Horst-Bruinsma I, Gensler LS. Certolizumab Pegol Reduced Anterior Uveitis Flares Compared With Standard Non-Biologic Treatment: Results From an Overlap Weighting Analysis in High-Risk Patients With Axial Spondyloarthritis. Int J Rheum Dis. 2026 Apr;29(4):e70621. doi: 10.1111/1756-185x.70621.
PubMed 41919656van der Horst-Bruinsma IE, van Bentum RE, Verbraak FD, Deodhar A, Rath T, Hoepken B, Irvin-Sellers O, Thomas K, Bauer L, Rudwaleit M. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803. doi: 10.1177/1759720X211003803. eCollection 2021.
PubMed 33854572
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03020992
- Acronym / sponsor ID
- C-VIEW / AS0007
- Keywords
- Axial Spondyloarthritis, axSpA, Anterior Uveitis, Certolizumab Pegol, Cimzia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certolizumab Pegol | Experimental | Drug: Certolizumab PegolSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab PegolAlso: Cimzia, CZP, CDP870* pharmaceutical form: solution for infusion in prefilled syringe * concentration: 200 mg/mL * route of administration: subcutaneous | Drug | Certolizumab Pegol |
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
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.
31 secondary outcomes
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
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
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
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
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 Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48
Time frame: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96
Time frame: Week 96
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48
Time frame: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96
Time frame: Week 96
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48
Time frame: Week 48
Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96
Time frame: Week 96
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48
Time frame: Week 48
Percentage of Participants With Assessment of 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 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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41919656Haroon N, Baskurt Z, Chim T, Inman RD, Kumke T, Tham R, Kim M, van der Horst-Bruinsma I, Gensler LS. Certolizumab Pegol Reduced Anterior Uveitis Flares Compared With Standard Non-Biologic Treatment: Results From an Overlap Weighting Analysis in High-Risk Patients With Axial Spondyloarthritis. Int J Rheum Dis. 2026 Apr;29(4):e70621. doi: 10.1111/1756-185x.70621.
- Derived from this study: PubMed 33854572van der Horst-Bruinsma IE, van Bentum RE, Verbraak FD, Deodhar A, Rath T, Hoepken B, Irvin-Sellers O, Thomas K, Bauer L, Rudwaleit M. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803. doi: 10.1177/1759720X211003803. eCollection 2021.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Certolizumab Pegol in people with Axial Spondyloarthritis (axSpA) and Anterior Uveitis (AU), run by UCB Biopharma SRL at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Poland, Czechia, Germany, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.