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)

• 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: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Axial Spondyloarthritis (axSpA); Anterior Uveitis (AU)
• Intervention: Drug: Certolizumab Pegol
• Enrollment: 89

Participant Flow

Recruitment Details	The first participant was enrolled in December 2016 and the last participant was enrolled in December 2017.
Pre-assignment Details	The study included 3 periods as follows: Period 1 (Screening Period) 1 to 5 weeks before Baseline, Period 2 (Treatment Period) Week 0 to Week 96 and Period 3 (FU Period) 10 weeks from the final dose of investigational medicinal product (IMP) received (Week 104). Participant Flow refers to the Safety Set.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description	Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).
Period Title: Overall Study
Started	89
Completed	83
Not Completed	6
Reason Not Completed
Adverse Event	5
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
Arm/Group Description		Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).
Overall Number of Baseline Participants		89
Baseline Analysis Population Description		The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who had received at least 1 dose of IMP.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	89 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	84 94.4%
	>=65 years	5 5.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	89 participants
		46.52 (11.24)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	89 participants
	Female	33 37.1%
	Male	56 62.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	89 participants
	White	87 97.8%
	Other or Mixed	2 2.2%

Outcome Measures

1. Primary Outcome

Title	Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
Description	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.
Time Frame	During the pre-study period and during the Treatment Period up to 96 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).

Arm/Group Title	Certolizumab Pegol (FAS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Mean (Standard Deviation); Unit of Measure: flares
Pre-study Historical	1.9 (0.9)
On-study CZP	0.3 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Certolizumab Pegol (FAS)
	Comments	The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods. Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Poisson regression
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.180
	Confidence Interval	(2-Sided) 95%; 0.116 to 0.281
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	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
Description	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.
Time Frame	During the pre-study period and during the Treatment Period up to 48 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).

Arm/Group Title	Certolizumab Pegol (FAS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: flares
Pre-study Historical	132.72; (109.76 to 159.06)
On-study CZP	18.56; (10.39 to 30.61)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).

Arm/Group Title	Certolizumab Pegol (FAS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: flares
Pre-study Historical	97.51; (83.24 to 113.53)
On-study CZP	17.67; (11.74 to 25.53)

4. Secondary Outcome

Title	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
Description	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.
Time Frame	During the pre-study period and during the Treatment Period up to 48 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).

Arm/Group Title	Certolizumab Pegol (FAS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: flares
Pre-study Historical	132.72; (109.76 to 159.06)
On-study CZP	18.56; (10.39 to 30.61)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).

Arm/Group Title	Certolizumab Pegol (FAS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: flares
Pre-study Historical	97.51; (83.24 to 113.53)
On-study CZP	17.67; (11.74 to 25.53)

6. Secondary Outcome

Title	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set (ES) who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing ASDAS at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-1.55 (1.03)

7. Secondary Outcome

Title	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing ASDAS at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-1.61 (1.08)

8. Secondary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASDAI at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.2 (2.3)

9. Secondary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASDAI at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.4 (2.2)

10. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48
Description	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)
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Measure Type: Number; Unit of Measure: percentage of participants
	75.6

11. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96
Description	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)
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Measure Type: Number; Unit of Measure: percentage of participants
	75.6

12. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48
Description	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)
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Measure Type: Number; Unit of Measure: percentage of participants
	53.5

13. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96
Description	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)
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Measure Type: Number; Unit of Measure: percentage of participants
	58.5

14. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Data not collected from participants in all Arms/Groups.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96
Description	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.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Data not collected from participants in all Arms/Groups.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

16. Secondary Outcome

Title	Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48
Description	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)
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Measure Type: Number; Unit of Measure: percentage of participants
	31.4

17. Secondary Outcome

Title	Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 96
Description	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)
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Percentages were based on the number of participants with an assessment at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Measure Type: Number; Unit of Measure: percentage of participants
	36.6

18. Secondary Outcome

Title	Change From Baseline in Tender Joint Count (44 Joint Count) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with at least one tender joint count at Baseline (N=59) and had a non-missing tender joint count at Week 48 (N=55).

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	55
Mean (Standard Deviation); Unit of Measure: tender joints
	-4.9 (6.7)

19. Secondary Outcome

Title	Change From Baseline in Tender Joint Count (44 Joint Count) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with at least one tender joint count at Baseline (N=59) and had a non-missing tender joint count at Week 96 (N=51).

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	51
Mean (Standard Deviation); Unit of Measure: tender joints
	-4.7 (8.2)

20. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with at least one swollen joint count at Baseline (N=33) and had a non-missing swollen joint count at Week 48 (N=32).

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	32
Mean (Standard Deviation); Unit of Measure: swollen joints
	-4.2 (4.8)

21. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with at least one swollen joint count at Baseline (N=33) and had a non-missing swollen joint count at Week 96 (N=30).

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	30
Mean (Standard Deviation); Unit of Measure: swollen joints
	-3.9 (5.2)

22. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing PhGADA at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-43.8 (21.6)

23. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing PhGADA at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-42.5 (27.1)

24. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing PtGADA at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.6 (2.5)

25. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing PtGADA at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.9 (2.7)

26. Secondary Outcome

Title	Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS)
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing total spinal pain assessment at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.8 (2.5)

27. Secondary Outcome

Title	Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS)
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing total spinal pain assessment at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-4.1 (2.6)

28. Secondary Outcome

Title	Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASFI at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-2.23 (2.33)

29. Secondary Outcome

Title	Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASFI at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-2.28 (2.53)

30. Secondary Outcome

Title	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
Description	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.
Time Frame	From Baseline to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASDAI at Week 48.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.7 (2.8)

31. Secondary Outcome

Title	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
Description	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.
Time Frame	From Baseline to Week 96

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Number of participants analyzed reflect those with a non-missing BASDAI at Week 96.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	82
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-3.8 (2.7)

32. Secondary Outcome

Title	Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study
Description	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.
Time Frame	From Baseline up to the Safety Follow-up Visit (up to Week 104)

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.

Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description:	Participants received 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 Q2W (starting at Week 6 until Week 94).
Overall Number of Participants Analyzed	89
Measure Type: Number; Unit of Measure: percentage of participants
	80.9

Adverse Events

Time Frame	Treatment emergent adverse events were collected from Baseline to the Safety Follow-up Visit (up to Week 104)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Certolizumab Pegol (SS)
Arm/Group Description	Participants received 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 Q2W (starting at Week 6 until Week 94).
All-Cause Mortality
	Certolizumab Pegol (SS)
	Affected / at Risk (%)
Total	0/89 (0.00%)
Serious Adverse Events
	Certolizumab Pegol (SS)
	Affected / at Risk (%)	# Events
Total	11/89 (12.36%)
Ear and labyrinth disorders
Vestibular disorder * 1	2/89 (2.25%)	2
Eye disorders
Uveitis * 1	1/89 (1.12%)	2
Gastrointestinal disorders
Anal polyp * 1	1/89 (1.12%)	1
General disorders
Incarcerated hernia * 1	1/89 (1.12%)	1
Hepatobiliary disorders
Cholelithiasis * 1	1/89 (1.12%)	1
Immune system disorders
Sarcoidosis * 1	1/89 (1.12%)	1
Infections and infestations
Pneumonia haemophilus * 1	1/89 (1.12%)	1
Pneumonia * 1	1/89 (1.12%)	1
Musculoskeletal and connective tissue disorders
Tenosynovitis * 1	1/89 (1.12%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer * 1	1/89 (1.12%)	1
Haemangioma * 1	1/89 (1.12%)	1
Prostate cancer * 1	2/89 (2.25%)	2
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	1/89 (1.12%)	1
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol (SS)
	Affected / at Risk (%)	# Events
Total	51/89 (57.30%)
Eye disorders
Uveitis * 1	14/89 (15.73%)	23
Iridocyclitis * 1	8/89 (8.99%)	12
Infections and infestations
Nasopharyngitis * 1	15/89 (16.85%)	22
Upper respiratory tract infection * 1	12/89 (13.48%)	15
Influenza * 1	6/89 (6.74%)	9
Rhinitis * 1	6/89 (6.74%)	9
Investigations
Alanine aminotransferase increased * 1	5/89 (5.62%)	5
Musculoskeletal and connective tissue disorders
Arthralgia * 1	6/89 (6.74%)	7
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain * 1	5/89 (5.62%)	5
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van 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.

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT03020992
• Other Study ID Numbers: AS0007; 2016-000343-14 ( EudraCT Number )
• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Results First Submitted: December 2, 2020
• Results First Posted: December 31, 2020
• Last Update Posted: February 9, 2021