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Trial record 1 of 1 for:    NCT02505542
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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02505542
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 21, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Axial Spondyloarthrithis
Ankylosing Spondylitis
Interventions Biological: Certolizumab Pegol
Other: Placebo
Enrollment 736
Recruitment Details The study started to enroll patients in July 2015 and concluded in April 2019.
Pre-assignment Details

The study included 2 parts: Part A with a Screening Period (up to 5 Weeks) and an Open-Label Period (Week 0 to Week 48) and Part B with a Double-Blind Period (Week 48 to Week 96) and a Safety Follow-Up Period (10 weeks after the last dose of study medication).

Participant Flow refers to the Open-Label Set.

Arm/Group Title Certolizumab Pegol Open-Label Placebo Double-Blind Certolizumab Pegol 200 mg Q2W Double-Blind Certolizumab Pegol 200 mg Q4W Double-Blind
Hide Arm/Group Description Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B. Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.
Period Title: Part A: Open-Label Period
Started 736 0 0 0
Completed 659 0 0 0
Not Completed 77 0 0 0
Reason Not Completed
Adverse Event             31             0             0             0
Lack of Efficacy             5             0             0             0
Protocol Violation             1             0             0             0
Lost to Follow-up             5             0             0             0
Withdrawal by Subject             27             0             0             0
New medical history available             1             0             0             0
Participant did not attend week 48 visit             1             0             0             0
Pregnancy             2             0             0             0
Sponsor directive             1             0             0             0
Medical monitor decision             1             0             0             0
Screening failure (detected too late)             1             0             0             0
Non-compliance             1             0             0             0
Period Title: Completed Part A, Did Not Enter Part B
Started 659 0 0 0
Completed 313 0 0 0
Not Completed 346 0 0 0
Reason Not Completed
Lack of Efficacy             2             0             0             0
Withdrawal by Subject             3             0             0             0
The subject was not eligible for Part B             341             0             0             0
Period Title: Part B: Double-Blind Period
Started 0 104 104 105
Started Escape Period 0 73 7 15
Completed 0 92 95 98
Not Completed 0 12 9 7
Reason Not Completed
Adverse Event             0             0             1             3
Lost to Follow-up             0             0             0             1
Withdrawal by Subject             0             8             7             2
Planning pregnancy             0             1             0             0
Week 94 missed             0             0             1             0
Patient was moved from the country             0             0             0             1
Lack of Efficacy             0             1             0             0
Miscalculation             0             1             0             0
Subject did not complete all visits             0             1             0             0
Arm/Group Title Certolizumab Pegol Open-Label
Hide Arm/Group Description Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.
Overall Number of Baseline Participants 736
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the The Open-Label Set (OLS) which consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in the Open-Label Period of the study (Part A).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 736 participants
<=18 years
7
   1.0%
Between 18 and 65 years
729
  99.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 736 participants
32.9  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 736 participants
Female
222
  30.2%
Male
514
  69.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 736 participants
American indian/alaskan native
2
   0.3%
Asian
38
   5.2%
Black
1
   0.1%
White
681
  92.5%
Other/Mixed
5
   0.7%
Missing
9
   1.2%
1.Primary Outcome
Title Percentage of Participants in Part B Who Did Not Experienced a Flare
Hide Description

A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (>) 3.5 at any visit during Part B up until Week 96.

A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.2
(13.0 to 29.2)
83.7
(75.1 to 90.2)
79.0
(70.0 to 86.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio > 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.822
Confidence Interval (2-Sided) 95%
9.605 to 38.864
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio > 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.069
Confidence Interval (2-Sided) 95%
7.395 to 27.955
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Sustained Remission at Week 48 in Part A
Hide Description

Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in the Open-Label Period of the study (Part A).
Arm/Group Title Certolizumab Pegol Open-Label (OLS)
Hide Arm/Group Description:

Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.

Participants formed the Open-Label Set (OLS).

Overall Number of Participants Analyzed 736
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.9
(40.3 to 47.6)
3.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

Disease activity was measured by categorical response variables:

  • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
  • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
  • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
  • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5

Missing data were handled using last observation carried forward (LOCF) methods.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).
Arm/Group Title Certolizumab Pegol Open-Label (OLS)
Hide Arm/Group Description:

Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.

Participants formed the Open-Label Set (OLS).

Overall Number of Participants Analyzed 736
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-ID 52.5
ASDAS-MD 22.8
ASDAS-HD 18.9
ASDAS-vHD 5.9
4.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

ASDAS improvement was measured by binary response variables:

  • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
  • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).
Arm/Group Title Certolizumab Pegol Open-Label (OLS)
Hide Arm/Group Description:

Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.

Participants formed the Open-Label Set (OLS).

Overall Number of Participants Analyzed 736
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-CII 76.6
ASDAS-MI 56.1
5.Secondary Outcome
Title Time to Flare in Part B
Hide Description

For those who met the criteria for flare (see primary efficacy variable), the time to flare was the length in days from randomization in Part B until the visit at which the criteria for flare were met. Participants who discontinued the study without meeting the criteria for flare were counted as experiencing a flare at the time of their last study visit.

The time to flare was analyzed using Kaplan-Meier methods. If Kaplan-Meier Estimate was NA for all estimates then more than 75 % failed to meet the flare condition.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Median (Inter-Quartile Range)
Unit of Measure: days
113
(84 to 257)
371
(371 to 371)
NA [1] 
(NA to NA)
[1]
Values were not calculated since more than 75 % failed to meet the flare condition.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

Disease activity was measured by categorical response variables:

  • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
  • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
  • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
  • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-ID 58.3 86.2 69.9
ASDAS-MD 25.0 13.8 22.9
ASDAS-HD 16.7 0 7.2
ASDAS-vHD 0 0 0
7.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

ASDAS improvement was measured by binary response variables:

  • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
  • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-CII 21.2 82.7 75.2
ASDAS-MI 10.6 67.3 58.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.940
Confidence Interval (2-Sided) 95%
8.950 to 35.961
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.385
Confidence Interval (2-Sided) 95%
5.952 to 21.778
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.653
Confidence Interval (2-Sided) 95%
8.333 to 37.399
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.863
Confidence Interval (2-Sided) 95%
5.670 to 24.822
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B
Hide Description

The ASAS20 response was 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 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) 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].

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
23.1 85.6 78.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 20.205
Confidence Interval (2-Sided) 95%
9.851 to 41.439
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.070
Confidence Interval (2-Sided) 95%
6.275 to 23.218
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B
Hide Description

The ASAS40 response was defined as a relative improvement 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: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
21.2 84.6 73.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 20.891
Confidence Interval (2-Sided) 95%
10.210 to 42.744
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.377
Confidence Interval (2-Sided) 95%
5.456 to 19.738
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B
Hide Description

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
12.5 70.2 62.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.900
Confidence Interval (2-Sided) 95%
8.211 to 34.785
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.072
Confidence Interval (2-Sided) 95%
5.954 to 24.476
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B
Hide Description

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
17.3 77.9 70.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.082
Confidence Interval (2-Sided) 95%
8.561 to 34.085
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.503
Confidence Interval (2-Sided) 95%
5.939 to 22.278
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

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.

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
1.66  (0.110) 0.24  (0.077) 0.45  (0.077)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-1.66 to -1.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.126
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-1.45 to -0.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.126
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B
Hide Description

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
3.02  (0.226) 0.56  (0.176) 0.78  (0.176)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -2.46
Confidence Interval (2-Sided) 95%
-2.99 to -1.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.268
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -2.24
Confidence Interval (2-Sided) 95%
-2.77 to -1.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.267
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B
Hide Description

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
1.90  (0.233) 0.32  (0.198) 0.46  (0.205)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-2.04 to -1.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.238
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -1.43
Confidence Interval (2-Sided) 95%
-1.90 to -0.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.238
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B
Hide Description

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
0.21  (0.105) 0.00  (0.065) -0.03  (0.068)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.074
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.42 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.112
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.036
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.46 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.113
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B
Hide Description

The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline.

Missing data were handled using non-response imputation (NRI) methods.

Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.
Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 104 104 105
Measure Type: Number
Unit of Measure: percentage of participants
22.1 83.7 77.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.308
Confidence Interval (2-Sided) 95%
9.084 to 36.898
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.020
Confidence Interval (2-Sided) 95%
6.255 to 23.098
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B
Hide Description

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description

The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The number of participants analyzed reflects Week 96.

Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 24 79 77
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.1  (3.6) 0.2  (2.4) 0.6  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments

Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.

Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.

ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.195
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.50 to 0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments

Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.

Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.

ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.432
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.11 to 0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B
Hide Description

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.

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

Time Frame From Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description

The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The number of participants analyzed reflects Week 96.

Arm/Group Title Placebo Double-Blind (RS) Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Randomized Set (RS).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the RS.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the RS.

Overall Number of Participants Analyzed 24 79 78
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.4  (0.9) 0.0  (0.8) 0.0  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q2W Double-Blind (RS)
Comments

Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.

Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.

ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.78 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Double-Blind (RS), Certolizumab Pegol 200 mg Q4W Double-Blind (RS)
Comments

Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.

Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.

ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.074
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.73 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

Disease activity was measured by categorical response variables:

  • ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3
  • ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1
  • ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5
  • ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-ID 63.4 16.7 60.0
ASDAS-MD 26.8 50.0 20.0
ASDAS-HD 8.5 33.3 20.0
ASDAS-vHD 1.4 0 0
20.Secondary Outcome
Title Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

ASDAS improvement was measured by binary response variables:

  • ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline
  • ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
ASDAS-CII 84.5 16.7 46.7
ASDAS-MI 49.3 0 13.3
21.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description The ASAS20 response was 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 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) 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].
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
83.3 50.0 64.3
22.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description The ASAS40 response was defined as a relative improvement 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: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
69.4 16.7 50.0
23.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
60.6 16.7 7.1
24.Secondary Outcome
Title Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
Time Frame Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 73 7 15
Measure Type: Number
Unit of Measure: percentage of participants
66.7 16.7 50.0
25.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).

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.

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

Time Frame From time of flare to Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 71 6 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.18  (1.13) -0.56  (0.64) -0.83  (0.94)
26.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

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

Time Frame From time of flare to Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 72 6 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.75  (2.52) -1.55  (1.05) -2.29  (2.35)
27.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.

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

Time Frame From time of flare to Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 72 6 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.52  (2.46) -0.72  (0.70) -1.83  (2.38)
28.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).

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

Time Frame From time of flare to Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 67 6 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.43  (0.58) -0.27  (0.35) -0.26  (0.30)
29.Secondary Outcome
Title Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.

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

Time Frame From time of flare to Escape Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 48 2 12
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-9.3  (13.2) 0.0  (0.0) 0.2  (3.1)
30.Secondary Outcome
Title Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B
Hide Description

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.

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

Time Frame From time of flare to Escape Week 12
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The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The number of participants analyzed reflects Escape Week 12.

Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (FS) CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (FS)
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Flared Set (FS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the FS.

Overall Number of Participants Analyzed 48 2 12
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.3  (4.6) 0.0  (0.0) -0.3  (1.0)
31.Secondary Outcome
Title Certolizumab Pegol (CZP) Plasma Concentration During the Study
Hide Description

CZP plasma concentration was measured in micrograms per milliliter (μg/mL). Blood sample measurements that were deemed to be below the level of quantification, were set to half the lower level of quantification (LLOQ) for analysis purposes. Summary statistics were only displayed if at least two-thirds of the values were above the LLOQ and if n was greater or equal to (>=) 4.

The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the PK of these patients. The CZP plasma concentration of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Time Frame From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)
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Hide Analysis Population Description
The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.
Arm/Group Title Placebo Double-Blind (PKSB) Certolizumab Pegol 200 mg Q2W Double-Blind (PKSB) Certolizumab Pegol 200 mg Q4W Double-Blind (PKSB)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Pharmacokinetic Set B (PKSB).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the PKSB.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the PKSB.

Overall Number of Participants Analyzed 101 102 105
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Part A Baseline Number Analyzed 99 participants 101 participants 105 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 4 Number Analyzed 101 participants 100 participants 104 participants
48.71
(85.76%)
53.39
(30.93%)
48.92
(43.17%)
Week 12 Number Analyzed 100 participants 101 participants 105 participants
30.91
(89.23%)
31.74
(50.79%)
30.69
(56.82%)
Week 24 Number Analyzed 100 participants 101 participants 104 participants
26.31
(135.58%)
30.23
(46.57%)
28.96
(58.38%)
Week 48/Part B Baseline Number Analyzed 98 participants 100 participants 104 participants
36.28
(74.18%)
36.59
(84.36%)
31.11
(138.29%)
Week 60 Number Analyzed 98 participants 100 participants 105 participants
NA [2] 
(NA%)
27.76
(49.47%)
6.95
(178.27%)
Week 72 Number Analyzed 76 participants 95 participants 99 participants
NA [2] 
(NA%)
26.36
(105.58%)
7.61
(176.39%)
Week 84 Number Analyzed 38 participants 91 participants 90 participants
NA [2] 
(NA%)
26.57
(44.90%)
8.00
(113.48%)
Week 96 Number Analyzed 27 participants 86 participants 85 participants
NA [2] 
(NA%)
24.76
(97.60%)
7.16
(131.76%)
Withdrawal Visit Number Analyzed 4 participants 3 participants 5 participants
0.81
(1802.40%)
NA [2] 
(NA%)
0.30
(2621.06%)
Escape Week 0/Flare Baseline Number Analyzed 72 participants 6 participants 14 participants
NA [2] 
(NA%)
30.77
(19.78%)
12.70
(98.45%)
Escape Week 2 Number Analyzed 71 participants 6 participants 15 participants
18.27
(488.45%)
33.50
(21.17%)
15.43
(124.10%)
Escape Week 4 Number Analyzed 71 participants 6 participants 15 participants
37.32
(151.18%)
32.94
(30.48%)
18.43
(79.93%)
Escape Week 12 Number Analyzed 69 participants 6 participants 15 participants
23.89
(232.36%)
23.76
(65.42%)
19.14
(136.22%)
Escape Week 24 Number Analyzed 54 participants 3 participants 8 participants
27.47
(45.31%)
NA [2] 
(NA%)
19.23
(66.68%)
Escape Week 36 Number Analyzed 14 participants 3 participants 3 participants
24.88
(77.53%)
NA [2] 
(NA%)
NA [2] 
(NA%)
Last Visit (Week 96) Number Analyzed 66 participants 6 participants 14 participants
24.64
(112.75%)
26.19
(54.74%)
18.59
(95.75%)
Withdrawal Escape Visit Number Analyzed 4 participants 1 participants 0 participants
4.71
(133329.3%)
NA [2] 
(NA%)
Safety Follow-up Number Analyzed 92 participants 92 participants 98 participants
NA [2] 
(NA%)
0.52
(1158.85%)
0.14
(772.54%)
[1]
Participants had no prior CZP treatment and thus no CZP levels at Baseline.
[2]
Values were below the level of detection.
32.Secondary Outcome
Title Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study
Hide Description

Treatment emergent ADAb status positive was defined as either baseline ADAb negative subjects having at least one ADAb confirmed positive sample post baseline or baseline ADAb positive subjects with at least one post baseline sample with >= minimum significant ratio (MSR) increase from baseline on CZP treatment. Once determined positive, the highest titer during Part A and Part B (including Escape and Safety Follow up) was used to categorize the subject.

The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the immunogenicity of these patients. The ADAb titer of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Time Frame From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.
Arm/Group Title Placebo Double-Blind (PKSB) Certolizumab Pegol 200 mg Q2W Double-Blind (PKSB) Certolizumab Pegol 200 mg Q4W Double-Blind (PKSB)
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Pharmacokinetic Set B (PKSB).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the PKSB.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the PKSB.

Overall Number of Participants Analyzed 101 102 105
Measure Type: Number
Unit of Measure: percentage of participants
100 96.1 100
33.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study
Hide Description An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), 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 Screening Period (Week -5 to Week -1) until Week 48
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The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of investigational medicinal product (IMP).
Arm/Group Title Certolizumab Pegol Open-Label (SS) Wk 0-48
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Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.

Participants formed the Safety Set (SS).

Overall Number of Participants Analyzed 736
Measure Type: Number
Unit of Measure: percentage of participants
Screening Period (Week -5 to Week -1) 7.3
Open-Label Period (Week 0 to Week 48) 67.9
34.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study
Hide Description

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date prior to the start date of escape CZP full-dose therapy were included.

Time Frame From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)
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Hide Analysis Population Description
The Safety Set Part B (SSB) consisted of all study participants in the Randomized Set (RS) who received at least 1 dose of IMP in the Double-Blind Period of the study (Part B).
Arm/Group Title Placebo Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96
Hide Arm/Group Description:

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Safety Set Part B (SSB).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the SSB.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the SSB.

Overall Number of Participants Analyzed 103 104 105
Measure Type: Number
Unit of Measure: percentage of participants
54.4 57.7 61.0
35.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study
Hide Description

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date after or on the start date of escape CZP full-dose therapy were included.

Time Frame From time of flare to Escape Week 12
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The Escape Therapy Set (ETS) consisted of all study participants from the Flared Set (FS) who received at least 1 dose of escape treatment.
Arm/Group Title Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12
Hide Arm/Group Description:

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Escape Therapy Set (ETS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the ETS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the ETS.

Overall Number of Participants Analyzed 72 6 15
Measure Type: Number
Unit of Measure: percentage of participants
51.4 83.3 46.7
Time Frame Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication).
Adverse Event Reporting Description TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
 
Arm/Group Title Certolizumab Pegol Open-Label (SS) Wk 0-48 Placebo Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12
Hide Arm/Group Description

Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.

Participants formed the Safety Set (SS).

Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.

Participants formed the Safety Set Part B (SSB).

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.

Participants formed the SSB.

Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.

Participants formed the SSB.

Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the Escape Therapy Set (ETS).

Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the ETS.

Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks.

Participants formed the ETS.

All-Cause Mortality
Certolizumab Pegol Open-Label (SS) Wk 0-48 Placebo Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/736 (0.00%)      0/103 (0.00%)      0/104 (0.00%)      0/105 (0.00%)      0/72 (0.00%)      0/6 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Certolizumab Pegol Open-Label (SS) Wk 0-48 Placebo Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/736 (5.98%)      0/103 (0.00%)      5/104 (4.81%)      0/105 (0.00%)      0/72 (0.00%)      1/6 (16.67%)      0/15 (0.00%)    
Blood and lymphatic system disorders               
Lymphadenopathy * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Cardiac disorders               
Tachycardia * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Eye disorders               
Retinal vein occlusion * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders               
Pancreatitis acute * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Colitis ulcerative * 1  2/736 (0.27%)  3 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Dental caries * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Glossitis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Crohn's disease * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Intestinal obstruction * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Irritable bowel syndrome * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Immune system disorders               
Drug hypersensitivity * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations               
Appendicitis * 1  2/736 (0.27%)  2 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Perirectal abscess * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Meningitis aseptic * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pulpitis dental * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Hepatitis E * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Abscess limb * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Wound infection * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pneumonia * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pneumonia mycoplasmal * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pulmonary tuberculosis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Tuberculous pleurisy * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Peritonsillar abscess * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pyelonephritis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Anal abscess * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Latent tuberculosis * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 1/104 (0.96%)  1 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications               
Meniscus injury * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Foot fracture * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Epicondylitis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Ligament rupture * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Tendon rupture * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Limb injury * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Investigations               
False positive tuberculosis test * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Intervertebral disc protrusion * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Axial spondyloarthritis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders               
Migraine * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Optic neuritis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pregnancy on contraceptive * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Psychiatric disorders               
Depression * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Schizophrenia * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders               
Ureterolithiasis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders               
Endometrial hyperplasia * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Chronic obstructive pulmonary disease * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Nasal septum deviation * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dermatitis atopic * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Dyshidrotic eczema * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Pustular psoriasis * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Urticaria * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol Open-Label (SS) Wk 0-48 Placebo Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   188/736 (25.54%)      25/103 (24.27%)      31/104 (29.81%)      26/105 (24.76%)      20/72 (27.78%)      5/6 (83.33%)      7/15 (46.67%)    
Blood and lymphatic system disorders               
Iron deficiency anaemia * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Eye disorders               
Iritis * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders               
Irritable bowel syndrome * 1  2/736 (0.27%)  2 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
General disorders               
Influenza like illness * 1  8/736 (1.09%)  9 1/103 (0.97%)  1 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Immune system disorders               
Drug hypersensitivity * 1  4/736 (0.54%)  4 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  2 0/15 (0.00%)  0
Infections and infestations               
Nasopharyngitis * 1  117/736 (15.90%)  156 8/103 (7.77%)  8 12/104 (11.54%)  17 13/105 (12.38%)  18 8/72 (11.11%)  9 2/6 (33.33%)  2 1/15 (6.67%)  1
Upper respiratory tract infection * 1  63/736 (8.56%)  88 10/103 (9.71%)  12 12/104 (11.54%)  14 11/105 (10.48%)  12 5/72 (6.94%)  7 1/6 (16.67%)  1 1/15 (6.67%)  1
Pharyngitis * 1  22/736 (2.99%)  24 3/103 (2.91%)  3 2/104 (1.92%)  2 6/105 (5.71%)  6 2/72 (2.78%)  2 0/6 (0.00%)  0 1/15 (6.67%)  1
Oral herpes * 1  13/736 (1.77%)  21 2/103 (1.94%)  3 1/104 (0.96%)  3 2/105 (1.90%)  2 1/72 (1.39%)  1 1/6 (16.67%)  3 0/15 (0.00%)  0
Hordeolum * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Influenza * 1  9/736 (1.22%)  9 1/103 (0.97%)  1 3/104 (2.88%)  3 1/105 (0.95%)  1 2/72 (2.78%)  3 1/6 (16.67%)  1 0/15 (0.00%)  0
Bronchitis * 1  24/736 (3.26%)  25 3/103 (2.91%)  3 0/104 (0.00%)  0 3/105 (2.86%)  3 1/72 (1.39%)  1 0/6 (0.00%)  0 1/15 (6.67%)  1
Conjunctivitis * 1  6/736 (0.82%)  6 1/103 (0.97%)  1 0/104 (0.00%)  0 1/105 (0.95%)  1 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Furuncle * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Laryngitis * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 1/105 (0.95%)  2 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Latent tuberculosis * 1  5/736 (0.68%)  5 0/103 (0.00%)  0 3/104 (2.88%)  3 2/105 (1.90%)  2 1/72 (1.39%)  1 0/6 (0.00%)  0 1/15 (6.67%)  1
Sinusitis * 1  12/736 (1.63%)  12 1/103 (0.97%)  1 0/104 (0.00%)  0 2/105 (1.90%)  2 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Investigations               
Antinuclear antibody increased * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Axial spondyloarthritis * 1  8/736 (1.09%)  8 8/103 (7.77%)  8 6/104 (5.77%)  6 1/105 (0.95%)  1 0/72 (0.00%)  0 0/6 (0.00%)  0 0/15 (0.00%)  0
Joint stiffness * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders               
Cervicogenic vertigo * 1  0/736 (0.00%)  0 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Sciatica * 1  1/736 (0.14%)  1 0/103 (0.00%)  0 0/104 (0.00%)  0 0/105 (0.00%)  0 0/72 (0.00%)  0 1/6 (16.67%)  1 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Oropharyngeal pain * 1  12/736 (1.63%)  14 0/103 (0.00%)  0 3/104 (2.88%)  3 2/105 (1.90%)  2 0/72 (0.00%)  0 0/6 (0.00%)  0 1/15 (6.67%)  1
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT02505542    
Other Study ID Numbers: AS0005
2015-000339-34 ( EudraCT Number )
First Submitted: July 16, 2015
First Posted: July 22, 2015
Results First Submitted: February 26, 2020
Results First Posted: April 21, 2020
Last Update Posted: July 2, 2020