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Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

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: NCT01087762
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : December 25, 2013
Last Update Posted : August 1, 2018
Sponsor:
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
Condition Spondyloarthropathies
Interventions Biological: CZP 200 mg Q2W
Biological: CZP 400 mg Q4W
Other: Placebo
Enrollment 325
Recruitment Details This is a multicenter study with 128 sites in North America, Latin America, Western Europe, and Central/Eastern Europe. 325 subjects are included in Randomized Set (RS) shown in Participant Flow for the interim period, and 315 for the final analysis (10 subjects dropped out before receiving a CZP dose), which is an Intention-to-Treat (ITT) dataset.
Pre-assignment Details Patients with positive Tuberculosis (TB) tests within Screening Period, but no signs and symptoms of active TB had to be treated with prophylactic TB treatment for at least 4 weeks prior to first study drug administration.
Arm/Group Title Placebo CZP 200 mg Q2W CZP 400 mg Q4W All CZP 200 mg All CZP 400 mg
Hide Arm/Group Description

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Period Title: Double Blind Period (Weeks 0-24)
Started 107 [1] 111 [1] 107 [1] 0 0
Completed 95 105 98 0 0
Not Completed 12 6 9 0 0
Reason Not Completed
Lack of Efficacy             2             0             3             0             0
Protocol Violation             6             0             1             0             0
Lost to Follow-up             1             2             1             0             0
Withdrawal by Subject             1             2             1             0             0
SAE, non-fatal             2             2             3             0             0
[1]
Completed 24-weeks Double-blind Period
Period Title: Open-Label Period (Weeks 48-204)
Started 0 0 0 158 157
Completed 0 0 0 99 100
Not Completed 0 0 0 59 57
Reason Not Completed
Lack of Efficacy             0             0             0             4             14
Protocol Violation             0             0             0             1             1
Lost to Follow-up             0             0             0             5             2
Withdrawal by Subject             0             0             0             22             15
Other             0             0             0             2             4
SAE, non-fatal             0             0             0             7             4
AE, non-serious non-fatal             0             0             0             16             13
SAE, non-fatal + AE, non-serious/fatal             0             0             0             2             4
Arm/Group Title Placebo CZP 200 mg Q2W CZP 400 mg Q4W Total Title
Hide Arm/Group Description

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

[Not Specified]
Overall Number of Baseline Participants 107 111 107 325
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set (RS), which is an Intention-to-Treat (ITT) dataset.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 111 participants 107 participants 325 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
102
  95.3%
110
  99.1%
105
  98.1%
317
  97.5%
>=65 years
5
   4.7%
1
   0.9%
2
   1.9%
8
   2.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean age Number Analyzed 107 participants 111 participants 107 participants 325 participants
39.9  (12.4) 39.1  (11.9) 39.8  (39.9) 39.6  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 111 participants 107 participants 325 participants
Female
42
  39.3%
44
  39.6%
39
  36.4%
125
  38.5%
Male
65
  60.7%
67
  60.4%
68
  63.6%
200
  61.5%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 107 participants 111 participants 107 participants 325 participants
82.142  (18.147) 79.305  (18.599) 83.893  (18.855) 81.757  (18.576)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 107 participants 111 participants 107 participants 325 participants
170.704  (9.692) 171.769  (10.171) 172.753  (9.607) 171.739  (9.834)
1.Primary Outcome
Title Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
Hide Description

The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:

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

and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.3
(29.1 to 47.5)
57.7
(48.5 to 66.8)
63.6
(54.4 to 72.7)
60.6
(54.1 to 67.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.
Method Wald-test, 2-sided
Comments Wald test and Confidence Interval (CI) calculation were performed without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
6.3 to 32.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.
Method Wald-test, 2-sided
Comments Wald test and Confidence Interval (CI) calculation were performed without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.2
Confidence Interval (2-Sided) 95%
12.3 to 38.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
Hide Description

The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:

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

and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.0
(20.4 to 37.6)
66.7
(57.9 to 75.4)
70.1
(61.4 to 78.8)
68.3
(62.2 to 74.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.
Method Wald-test, 2-sided
Comments Wald test and Confidence Interval (CI) calculation were performed without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 37.7
Confidence Interval (2-Sided) 95%
25.4 to 50.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.
Method Wald-test, 2-sided
Comments Wald test and Confidence Interval (CI) calculation were performed without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 41.1
Confidence Interval (2-Sided) 95%
28.9 to 53.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
Hide Description The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.53
(-0.96 to -0.10)
-2.01
(-2.48 to -1.55)
-2.02
(-2.50 to -1.55)
-2.02
(-2.40 to -1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.49
Confidence Interval (2-Sided) 95%
-1.96 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Hide Description The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.40
(-0.85 to 0.06)
-2.36
(-2.85 to -1.87)
-2.20
(-2.70 to -1.70)
-2.28
(-2.68 to -1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.88
Confidence Interval (2-Sided) 95%
-2.38 to -1.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
Hide Description The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.22
(-1.65 to -0.78)
-2.82
(-3.29 to -2.35)
-2.80
(-3.28 to -2.33)
-2.81
(-3.20 to -2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.07 to -1.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Hide Description The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.05
(-1.50 to -0.60)
-3.08
(-3.57 to -2.60)
-3.01
(-3.50 to -2.52)
-3.05
(-3.45 to -2.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-2.49 to -1.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
Hide Description The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It 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 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.13
(-0.31 to 0.05)
-0.60
(-0.79 to -0.40)
-0.46
(-0.66 to -0.26)
-0.53
(-0.69 to -0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.60 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
Hide Description The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It 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 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 107 111 107 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.07
(-0.27 to 0.12)
-0.54
(-0.75 to -0.34)
-0.49
(-0.70 to -0.28)
-0.52
(-0.69 to -0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.66 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
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. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is 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. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 49 47 52 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.39  (4.04) -3.39  (5.59) -2.16  (3.61) -2.74  (4.67)
10.Secondary Outcome
Title Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
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. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.
Arm/Group Title Placebo (FAS) CZP 200 mg Q2W (FAS) CZP 400 mg Q4W (FAS) CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
Hide Arm/Group Description:

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

Subjects 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 onwards.

At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.

Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.

Subjects in both CZP arms received additional placebo injections to maintain the study blind.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Overall Number of Participants Analyzed 45 45 50 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.33  (8.33) -3.61  (6.94) -4.98  (8.47) -4.33  (7.77)
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
Adverse Event Reporting Description As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
 
Arm/Group Title All CZP 200 mg (Safety Analysis) All CZP 400 mg (Safety Analysis) All CZP 200 mg + 400 mg Placebo
Hide Arm/Group Description

All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

Placebo : Matching Placebo to CZP injection.

CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).

All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.

Placebo : Matching Placebo to CZP injection.

CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.

Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.

After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).

Placebo : Matching Placebo to CZP injection.

All-Cause Mortality
All CZP 200 mg (Safety Analysis) All CZP 400 mg (Safety Analysis) All CZP 200 mg + 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All CZP 200 mg (Safety Analysis) All CZP 400 mg (Safety Analysis) All CZP 200 mg + 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/158 (22.15%)      34/157 (21.66%)      69/315 (21.90%)      5/107 (4.67%)    
Blood and lymphatic system disorders         
Hilar lymphadenopathy * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Lymphadenopathy * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Paratracheal lymphadenopathy * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Cardiac disorders         
Coronary artery disease * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Acute myocardial infarction * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Atrial fibrillation * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Supraventricular tachycardia * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Eye disorders         
Retinal vein occlusion * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Gastrointestinal disorders         
Colitis * 1  0/158 (0.00%)  0 3/157 (1.91%)  3 3/315 (0.95%)  3 0/107 (0.00%)  0
Colitis ulcerative * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Sigmoiditis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Diarrhoea * 1  0/158 (0.00%)  0 2/157 (1.27%)  2 2/315 (0.63%)  2 0/107 (0.00%)  0
Gastritis * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Abdominal pain * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Crohn's disease * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Inguinal hernia * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Lower gastrointestinal haemorrhage * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Inflammatory bowel disease * 1  0/158 (0.00%)  0 0/157 (0.00%)  0 0/315 (0.00%)  0 1/107 (0.93%)  1
General disorders         
Chest pain * 1  1/158 (0.63%)  1 1/157 (0.64%)  1 2/315 (0.63%)  2 0/107 (0.00%)  0
Non-cardiac chest pain * 1  2/158 (1.27%)  2 0/157 (0.00%)  0 2/315 (0.63%)  2 2/107 (1.87%)  2
Hepatobiliary disorders         
Cholelithiasis * 1  0/158 (0.00%)  0 2/157 (1.27%)  2 2/315 (0.63%)  2 0/107 (0.00%)  0
Cholelithiasis migration * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Hepatitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Immune system disorders         
Hypersensitivity * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 1/107 (0.93%)  1
Infections and infestations         
Anal abscess * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Appendicitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Diverticulitis * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Mycobacterial infection * 1  1/158 (0.63%)  1 1/157 (0.64%)  1 2/315 (0.63%)  2 0/107 (0.00%)  0
Cellulitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Oesophageal candidiasis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Haemophilus infection * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Herpes zoster disseminated * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Pneumonia legionella * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Pneumonia * 1  3/158 (1.90%)  5 0/157 (0.00%)  0 3/315 (0.95%)  5 0/107 (0.00%)  0
Infected dermal cyst * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Subcutaneous abscess * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Latent tuberculosis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Pulmonary tuberculosis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Acute sinusitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Laryngitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Upper respiratory tract infection * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Pyelonephritis * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Injury, poisoning and procedural complications         
Joint dislocation * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Multiple fractures * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Meniscus lesion * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Ligament rupture * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Radius fracture * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Investigations         
Gamma-glutamyltransferase increased * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Weight decreased * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycaemia * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthritis * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Rotator cuff syndrome * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Back pain * 1  1/158 (0.63%)  1 1/157 (0.64%)  1 2/315 (0.63%)  2 0/107 (0.00%)  0
Osteoarthritis * 1  3/158 (1.90%)  3 0/157 (0.00%)  0 3/315 (0.95%)  3 0/107 (0.00%)  0
Ankylosing spondylitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Spondylitis * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cholesterol granuloma * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Breast cancer * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Squamous cell carcinoma of the * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Astrocytoma * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Morton's neuroma * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Renal cell carcinoma * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Nervous system disorders         
Intracranial aneurysm * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Cerebrovascular insufficiency * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Transient ischaemic attack * 1  2/158 (1.27%)  2 0/157 (0.00%)  0 2/315 (0.63%)  2 0/107 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Pregnancy on contraceptive * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Psychiatric disorders         
Major depression * 1  1/158 (0.63%)  2 1/157 (0.64%)  1 2/315 (0.63%)  3 0/107 (0.00%)  0
Hallucination * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Psychotic disorder * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Conversion disorder * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Renal and urinary disorders         
Ureteric obstruction * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Renal colic * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Calculus ureteric * 1  0/158 (0.00%)  0 0/157 (0.00%)  0 0/315 (0.00%)  0 1/107 (0.93%)  1
Reproductive system and breast disorders         
Benign prostatic hyperplasia * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary * 1  1/158 (0.63%)  2 0/157 (0.00%)  0 1/315 (0.32%)  2 0/107 (0.00%)  0
Hypoxia * 1  1/158 (0.63%)  2 0/157 (0.00%)  0 1/315 (0.32%)  2 0/107 (0.00%)  0
Diffuse alveolar damage * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Nasal congestion * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Nasal polyps * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Skin and subcutaneous tissue disorders         
Psoriasis * 1  0/158 (0.00%)  0 1/157 (0.64%)  1 1/315 (0.32%)  1 0/107 (0.00%)  0
Dermal cyst * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Surgical and medical procedures         
Bone graft * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
Abortion induced * 1  1/158 (0.63%)  1 0/157 (0.00%)  0 1/315 (0.32%)  1 0/107 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All CZP 200 mg (Safety Analysis) All CZP 400 mg (Safety Analysis) All CZP 200 mg + 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   142/158 (89.87%)      127/157 (80.89%)      269/315 (85.40%)      28/107 (26.17%)    
Eye disorders         
Uveitis * 1  11/158 (6.96%)  15 8/157 (5.10%)  12 19/315 (6.03%)  27 0/107 (0.00%)  0
Conjunctivitis * 1  5/158 (3.16%)  6 8/157 (5.10%)  9 13/315 (4.13%)  15 0/107 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea * 1  10/158 (6.33%)  13 20/157 (12.74%)  26 30/315 (9.52%)  39 0/107 (0.00%)  0
Gastritis * 1  8/158 (5.06%)  8 5/157 (3.18%)  5 13/315 (4.13%)  13 0/107 (0.00%)  0
Immune system disorders         
Seasonal allergy * 1  7/158 (4.43%)  8 8/157 (5.10%)  11 15/315 (4.76%)  19 0/107 (0.00%)  0
Infections and infestations         
Nasopharyngitis * 1  47/158 (29.75%)  80 43/157 (27.39%)  83 90/315 (28.57%)  163 7/107 (6.54%)  8
Upper respiratory tract infection * 1  35/158 (22.15%)  53 28/157 (17.83%)  58 63/315 (20.00%)  111 3/107 (2.80%)  3
Bronchitis * 1  24/158 (15.19%)  28 17/157 (10.83%)  18 41/315 (13.02%)  46 0/107 (0.00%)  0
Pharyngitis * 1  24/158 (15.19%)  36 11/157 (7.01%)  17 35/315 (11.11%)  53 0/107 (0.00%)  0
Sinusitis * 1  17/158 (10.76%)  21 8/157 (5.10%)  10 25/315 (7.94%)  31 0/107 (0.00%)  0
Urinary tract infection * 1  10/158 (6.33%)  17 11/157 (7.01%)  15 21/315 (6.67%)  32 4/107 (3.74%)  4
Rhinitis * 1  15/158 (9.49%)  22 6/157 (3.82%)  8 21/315 (6.67%)  30 0/107 (0.00%)  0
Influenza * 1  9/158 (5.70%)  10 11/157 (7.01%)  14 20/315 (6.35%)  24 0/107 (0.00%)  0
Tonsillitis * 1  8/158 (5.06%)  10 9/157 (5.73%)  11 17/315 (5.40%)  21 0/107 (0.00%)  0
Oral herpes * 1  9/158 (5.70%)  23 6/157 (3.82%)  7 15/315 (4.76%)  30 0/107 (0.00%)  0
Cystitis * 1  8/158 (5.06%)  13 6/157 (3.82%)  10 14/315 (4.44%)  21 0/107 (0.00%)  0
Gastroenteritis * 1  5/158 (3.16%)  5 9/157 (5.73%)  9 14/315 (4.44%)  14 0/107 (0.00%)  0
Viral infection * 1  9/158 (5.70%)  10 4/157 (2.55%)  4 13/315 (4.13%)  14 0/107 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion * 1  10/158 (6.33%)  18 9/157 (5.73%)  11 19/315 (6.03%)  29 0/107 (0.00%)  0
Investigations         
Blood creatine phosphokinase increased * 1  14/158 (8.86%)  16 17/157 (10.83%)  23 31/315 (9.84%)  39 2/107 (1.87%)  3
Alanine aminotransferase increased * 1  11/158 (6.96%)  14 8/157 (5.10%)  10 19/315 (6.03%)  24 0/107 (0.00%)  0
Tuberculin test positive * 1  8/158 (5.06%)  8 7/157 (4.46%)  7 15/315 (4.76%)  15 0/107 (0.00%)  0
Aspartate aminotransferase increased * 1  6/158 (3.80%)  6 8/157 (5.10%)  9 14/315 (4.44%)  15 0/107 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  22/158 (13.92%)  42 11/157 (7.01%)  20 33/315 (10.48%)  62 0/107 (0.00%)  0
Back pain * 1  14/158 (8.86%)  18 11/157 (7.01%)  19 25/315 (7.94%)  37 0/107 (0.00%)  0
Spondylitis * 1  12/158 (7.59%)  22 13/157 (8.28%)  14 25/315 (7.94%)  36 0/107 (0.00%)  0
Ankylosing spondylitis * 1  11/158 (6.96%)  17 5/157 (3.18%)  8 16/315 (5.08%)  25 0/107 (0.00%)  0
Pain in extremity * 1  10/158 (6.33%)  11 3/157 (1.91%)  4 13/315 (4.13%)  15 0/107 (0.00%)  0
Nervous system disorders         
Headache * 1  17/158 (10.76%)  25 18/157 (11.46%)  31 35/315 (11.11%)  56 7/107 (6.54%)  11
Psychiatric disorders         
Depression * 1  9/158 (5.70%)  10 4/157 (2.55%)  5 13/315 (4.13%)  15 0/107 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough * 1  13/158 (8.23%)  16 11/157 (7.01%)  13 24/315 (7.62%)  29 0/107 (0.00%)  0
Oropharyngeal pain * 1  12/158 (7.59%)  15 6/157 (3.82%)  6 18/315 (5.71%)  21 0/107 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash * 1  11/158 (6.96%)  15 14/157 (8.92%)  18 25/315 (7.94%)  33 2/107 (1.87%)  2
Psoriasis * 1  8/158 (5.06%)  14 6/157 (3.82%)  9 14/315 (4.44%)  23 0/107 (0.00%)  0
Eczema * 1  4/158 (2.53%)  6 8/157 (5.10%)  13 12/315 (3.81%)  19 0/107 (0.00%)  0
Vascular disorders         
Hypertension * 1  20/158 (12.66%)  26 11/157 (7.01%)  11 31/315 (9.84%)  37 4/107 (3.74%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA14.1
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: +1887822 ext 9493
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01087762     History of Changes
Other Study ID Numbers: AS001
2009-011719-19 ( EudraCT Number )
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: November 6, 2013
Results First Posted: December 25, 2013
Last Update Posted: August 1, 2018