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Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT01087788
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : February 25, 2014
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 Arthritis, Psoriatic
Interventions Biological: CZP 200 mg Q2W
Biological: CZP 400 mg Q4W
Other: Placebo
Enrollment 409
Recruitment Details This study started to enroll patients in March 2010 and concluded in August 2015.
Pre-assignment Details

The study included a 24-week Double-Blind, a 24-week Dose-Blind, and an Open-Label Treatment Period.

409 subjects are included in Randomized Set (RS) shown in the Participant Flow, which is an Intention- to- Treat (ITT) dataset.

Arm/Group Title Placebo CZP 200 mg Q2W CZP 400 mg Q4W
Hide Arm/Group Description

Matching Placebo (PBO) 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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

Period Title: 24-weeks Double-blind Period
Started 136 138 135
Received CZP 200 mg Q2W at 16 Weeks 30 [1] 0 [2] 0 [2]
Received CZP 400 mg Q4W at 16 Weeks 29 [3] 0 [2] 0 [2]
Completed 120 128 120
Not Completed 16 10 15
Reason Not Completed
Lack of Efficacy             2             0             1
Protocol Violation             0             1             0
Lost to Follow-up             4             1             1
Withdrawal by Subject             7             2             5
AE, serious fatal             0             1             1
AE, serious non-fatal             0             2             3
AE, non-serious non-fatal             2             1             2
AE, unknown type             0             0             1
Patient (P) does not want to attend             1             0             0
Protocol violation (decision of monitor)             0             1             0
Exclusion criteria were not met             0             1             0
P cannot comply with scheduled visits             0             0             1
[1]
30 subjects left the Placebo group and were re-randomized to CZP 200 mg Q2W on Week 16.
[2]
not applicable for this arm
[3]
29 subjects left the Placebo group and were re-randomized to CZP 400 mg Q4W on Week 16.
Period Title: 24-weeks Dose-blind Period
Started 120 128 120
Received CZP 200 mg Q2W at 24 Weeks 60 [1] 0 [2] 0 [2]
Received CZP 400 mg Q2W at 24 Weeks 60 [3] 0 [2] 0 [2]
Completed 113 123 114
Not Completed 7 5 6
Reason Not Completed
Lack of Efficacy             0             2             1
Lost to Follow-up             1             0             1
Withdrawal by Subject             1             0             0
AE, serious fatal             0             1             0
AE, serious non-fatal             2             1             2
AE, non-serious non-fatal             2             1             1
Sponsor decision following missed visits             1             0             0
Patient moved             0             0             1
[1]
Sum of subjects re-randomized to CZP 200mg Q2W at week 16 (30 subjects) and at week 24 (30 subjects)
[2]
not applicable for this arm
[3]
Sum of subjects re-randomized to CZP 400mg Q2W at week 16 (29 subjects) and at week 24 (31 subjects)
Period Title: Open-Label Period (OL-P)
Started 111 [1] 121 [1] 114
Completed 81 97 86
Not Completed 30 24 28
Reason Not Completed
Lack of Efficacy             4             2             3
Protocol Violation             2             1             0
Lost to Follow-up             0             4             2
Withdrawal by Subject             13             8             10
AE, serious fatal             2             0             1
AE, serious non-fatal             1             3             4
AE, non-serious non-fatal             6             4             4
SAE, non-fatal+AE, non-serious non-fatal             0             1             0
AE, non-serious unknown             1             0             0
Sponsor request             1             0             0
Principal investigator decision             0             1             2
No participation in study extension             0             0             1
Personal reasons             0             0             1
[1]
2 subj. completed the Dose-Blind Period, then withdrew from the study rather than entering the OL-P.
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

[Not Specified]
Overall Number of Baseline Participants 136 138 135 409
Hide Baseline Analysis Population Description
409 subjects are included in Randomized Set (RS) shown in Baseline Characteristics, which is an Intention-to-Treat (ITT) dataset.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 135 participants 409 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
129
  94.9%
126
  91.3%
128
  94.8%
383
  93.6%
>=65 years
7
   5.1%
12
   8.7%
7
   5.2%
26
   6.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 138 participants 135 participants 409 participants
47.3  (11.1) 48.2  (12.3) 47.1  (10.8) 47.6  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 135 participants 409 participants
Female
79
  58.1%
74
  53.6%
73
  54.1%
226
  55.3%
Male
57
  41.9%
64
  46.4%
62
  45.9%
183
  44.7%
1.Primary Outcome
Title American College of Rheumatology 20 (ACR20) Response at Week 12
Hide Description ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
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 nonresponders 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 (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

Overall Number of Participants Analyzed 136 138 135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.3
(17.1 to 31.5)
58.0
(49.7 to 66.2)
51.9
(43.4 to 60.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W (Randomized Set)
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 [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
22.8 to 44.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 400 mg Q4W (Randomized Set)
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 [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 27.6
Confidence Interval (2-Sided) 95%
16.5 to 38.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
Hide Description Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.
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 imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.
Arm/Group Title Placebo (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set) CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.

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.

Overall Number of Participants Analyzed 136 138 135 273
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Pre-defined results
28.92
(13.73 to 44.11)
11.52
(-3.40 to 26.45)
25.05
(9.48 to 40.61)
18.28
(6.34 to 30.23)
Re-analysis results ( n = 123, 130, 123, 253)
0.18
(0.04 to 0.33)
-0.02
(-0.16 to 0.11)
0.09
(-0.05 to 0.23)
0.03
(-0.08 to 0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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. This is the pre-defined primary analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.203
Comments Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors & BL mTSS score as a covariate
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -10.64
Confidence Interval (2-Sided) 95%
-27.05 to 5.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W (Randomized Set)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.017
Comments Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.38 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 400 mg Q4W (Randomized Set)
Comments A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.261
Comments Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.27 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title American College of Rheumatology 20 (ACR20) Response at Week 24
Hide Description ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
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 nonresponders 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 (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

Overall Number of Participants Analyzed 136 138 135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.5
(16.4 to 30.7)
63.8
(55.7 to 71.8)
56.3
(47.9 to 64.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W (Randomized Set)
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 [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 40.2
Confidence Interval (2-Sided) 95%
29.5 to 51.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 400 mg Q4W (Randomized Set)
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 [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 32.8
Confidence Interval (2-Sided) 95%
21.8 to 43.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
Hide Description The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher 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 (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set) CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.

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.

Overall Number of Participants Analyzed 136 138 135 273
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.19
(-0.29 to -0.09)
-0.54
(-0.64 to -0.44)
-0.46
(-0.56 to -0.36)
-0.50
(-0.58 to -0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.42 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline
Hide Description The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.
Time Frame Week 24
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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 nonresponders 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 (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set) CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.

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.

Overall Number of Participants Analyzed 86 90 76 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.1
(7.5 to 22.7)
62.2
(52.2 to 72.2)
60.5
(49.5 to 71.5)
61.4
(54.0 to 68.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 + 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 [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 46.3
Confidence Interval (2-Sided) 95%
35.7 to 56.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
Hide Description

Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome).

For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6.

Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.
Arm/Group Title Placebo (Randomized Set) CZP 200 mg Q2W (Randomized Set) CZP 400 mg Q4W (Randomized Set) CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.

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

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.

This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.

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.

Overall Number of Participants Analyzed 136 138 135 273
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Predefined results: Overall
0.32
(0.10 to 0.55)
0.15
(-0.07 to 0.37)
0.11
(-0.12 to 0.34)
0.13
(-0.05 to 0.31)
Post-hoc results: Basel. mTSS > 6 (n=61,65,65,130)
0.78
(0.31 to 1.25)
0.31
(-0.15 to 0.77)
0.22
(-0.24 to 0.67)
0.26
(-0.09 to 0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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. This is the predefined analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.127
Comments Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.43 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Randomized Set), CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)
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. This is the post-hoc analysis for the subgroup 'Baseline mTSS > 6'.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.048
Comments Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference (Net)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.04 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) over the whole Double-Blind, Dose-Blind and Open-Label Period up to Week 216.
Adverse Event Reporting Description As per study design, placebo (PBO) arm subjects shifted either at Week (Wk) 16 or 24 to CZP treatment. Thus, PBO arm had lower exposure compared to the CZP arms. The exposure imbalance across treatment arms could lead to misinterpretation & questionable conclusions comparing simple counts & percentages of AEs. Thus, AEs reported while the patient was on PBO-treatment are not included.
 
Arm/Group Title All CZP 200 mg Q2W All CZP 400 mg Q4W All CZP 200 mg + 400 mg
Hide Arm/Group Description

This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.

Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind.

This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.

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

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 Q2W and arm All CZP 400 mg Q4W.
All-Cause Mortality
All CZP 200 mg Q2W All CZP 400 mg Q4W All CZP 200 mg + 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All CZP 200 mg Q2W All CZP 400 mg Q4W All CZP 200 mg + 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/198 (24.75%)      51/195 (26.15%)      100/393 (25.45%)    
Blood and lymphatic system disorders       
Splenomegaly * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Thrombocytopenia * 1  0/198 (0.00%)  0 1/195 (0.51%)  2 1/393 (0.25%)  2
Cardiac disorders       
Coronary artery thrombosis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Angina unstable * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Myocardial infarction * 1  2/198 (1.01%)  2 0/195 (0.00%)  0 2/393 (0.51%)  2
Acute myocardial infarction * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Myocarditis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Atrial fibrillation * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Cardiac arrest * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Ear and labyrinth disorders       
Tinnitus * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Eye disorders       
Cataract * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Diplopia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Gastrointestinal disorders       
Abdominal hernia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Pancreatitis acute * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Abdominal pain * 1  1/198 (0.51%)  2 0/195 (0.00%)  0 1/393 (0.25%)  2
Crohn's disease * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Hypoaesthesia oral * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
General disorders       
Sudden death * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Pyrexia * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Chest pain * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Hepatobiliary disorders       
Biliary colic * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Cholelithiasis * 1  1/198 (0.51%)  1 2/195 (1.03%)  2 3/393 (0.76%)  3
Cholecystitis * 1  0/198 (0.00%)  0 2/195 (1.03%)  2 2/393 (0.51%)  2
Biliary dyskinesia * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Bile duct obstruction * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Infections and infestations       
Diverticulitis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Cellulitis * 1  2/198 (1.01%)  2 0/195 (0.00%)  0 2/393 (0.51%)  2
Arthritis bacterial * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Herpes zoster * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Device related infection * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Postoperative wound infection * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Pneumonia * 1  1/198 (0.51%)  1 3/195 (1.54%)  4 4/393 (1.02%)  5
Bronchitis * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Bronchopneumonia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
HIV infection * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Sepsis * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Staphylococcal abscess * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Erysipelas * 1  2/198 (1.01%)  2 0/195 (0.00%)  0 2/393 (0.51%)  2
Pyoderma streptococcal * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Latent tuberculosis * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Upper respiratory tract infection * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Chronic tonsillitis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Urinary tract infection * 1  1/198 (0.51%)  1 2/195 (1.03%)  2 3/393 (0.76%)  3
Pyelonephritis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Pyelonephritis acute * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Injury, poisoning and procedural complications       
Concussion * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Joint injury * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Synovial rupture * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Foot fracture * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Lower limb fracture * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Tendon rupture * 1  0/198 (0.00%)  0 2/195 (1.03%)  2 2/393 (0.51%)  2
Animal bite * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Wound * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Anastomotic complication * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Hand fracture * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Investigations       
Hepatic enzyme increased * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Metabolism and nutrition disorders       
Diabetes mellitus * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Obesity * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Hyperglycaemia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Dehydration * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Musculoskeletal and connective tissue disorders       
Arthritis * 1  2/198 (1.01%)  2 1/195 (0.51%)  1 3/393 (0.76%)  3
Foot deformity * 1  0/198 (0.00%)  0 2/195 (1.03%)  2 2/393 (0.51%)  2
Lupus-like syndrome * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Osteoarthritis * 1  1/198 (0.51%)  1 3/195 (1.54%)  3 4/393 (1.02%)  4
Psoriatic arthropathy * 1  5/198 (2.53%)  5 3/195 (1.54%)  7 8/393 (2.04%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer * 1  1/198 (0.51%)  1 2/195 (1.03%)  2 3/393 (0.76%)  3
Gastrointestinal cancer metastatic * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Lymphoma * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Ovarian cancer * 1  1/198 (0.51%)  2 0/195 (0.00%)  0 1/393 (0.25%)  2
Benign neoplasm of thyroid gland * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Nervous system disorders       
Cerebrovascular accident * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Dysgraphia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Syncope * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Formication * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Paralysis * 1  1/198 (0.51%)  2 0/195 (0.00%)  0 1/393 (0.25%)  2
Epilepsy * 1  0/198 (0.00%)  0 1/195 (0.51%)  2 1/393 (0.25%)  2
Hypoaesthesia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Speech disorder * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Transient ischaemic attack * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Pregnancy on contraceptive * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Psychiatric disorders       
Bipolar I disorder * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Acute stress disorder * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Post-traumatic stress disorder * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Renal and urinary disorders       
Urinary incontinence * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Renal cyst * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Calculus ureteric * 1  0/198 (0.00%)  0 2/195 (1.03%)  2 2/393 (0.51%)  2
Renal colic * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Reproductive system and breast disorders       
Metrorrhagia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Genital prolapse * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Uterine haemorrhage * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Uterine polyp * 1  0/198 (0.00%)  0 2/195 (1.03%)  2 2/393 (0.51%)  2
Vulvar dysplasia * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Respiratory, thoracic and mediastinal disorders       
Hypoxia * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Haemoptysis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Lung infiltration * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Pleurisy * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Pulmonary embolism * 1  3/198 (1.52%)  3 0/195 (0.00%)  0 3/393 (0.76%)  3
Skin and subcutaneous tissue disorders       
Cutaneous lupus erythematosus * 1  1/198 (0.51%)  2 0/195 (0.00%)  0 1/393 (0.25%)  2
Skin ulcer * 1  3/198 (1.52%)  4 1/195 (0.51%)  1 4/393 (1.02%)  5
Social circumstances       
Pregnancy of partner * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Surgical and medical procedures       
Hip arthroplasty * 1  0/198 (0.00%)  0 1/195 (0.51%)  1 1/393 (0.25%)  1
Vascular disorders       
Haematoma * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
Thrombophlebitis * 1  1/198 (0.51%)  1 1/195 (0.51%)  1 2/393 (0.51%)  2
Deep vein thrombosis * 1  1/198 (0.51%)  1 0/195 (0.00%)  0 1/393 (0.25%)  1
*
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 Q2W All CZP 400 mg Q4W All CZP 200 mg + 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/198 (79.80%)      153/195 (78.46%)      311/393 (79.13%)    
Gastrointestinal disorders       
Diarrhoea * 1  15/198 (7.58%)  20 11/195 (5.64%)  15 26/393 (6.62%)  35
Abdominal pain * 1  12/198 (6.06%)  13 9/195 (4.62%)  10 21/393 (5.34%)  23
Abdominal pain upper * 1  14/198 (7.07%)  16 5/195 (2.56%)  9 19/393 (4.83%)  25
Nausea * 1  10/198 (5.05%)  11 8/195 (4.10%)  9 18/393 (4.58%)  20
Infections and infestations       
Upper respiratory tract infection * 1  44/198 (22.22%)  81 49/195 (25.13%)  73 93/393 (23.66%)  154
Nasopharyngitis * 1  45/198 (22.73%)  87 42/195 (21.54%)  91 87/393 (22.14%)  178
Pharyngitis * 1  24/198 (12.12%)  44 27/195 (13.85%)  37 51/393 (12.98%)  81
Bronchitis * 1  28/198 (14.14%)  36 22/195 (11.28%)  29 50/393 (12.72%)  65
Urinary tract infection * 1  13/198 (6.57%)  18 26/195 (13.33%)  35 39/393 (9.92%)  53
Sinusitis * 1  19/198 (9.60%)  32 13/195 (6.67%)  33 32/393 (8.14%)  65
Gastroenteritis * 1  14/198 (7.07%)  18 8/195 (4.10%)  8 22/393 (5.60%)  26
Oral herpes * 1  10/198 (5.05%)  25 11/195 (5.64%)  18 21/393 (5.34%)  43
Influenza * 1  13/198 (6.57%)  15 8/195 (4.10%)  9 21/393 (5.34%)  24
Tonsillitis * 1  11/198 (5.56%)  11 8/195 (4.10%)  12 19/393 (4.83%)  23
Rhinitis * 1  10/198 (5.05%)  11 9/195 (4.62%)  9 19/393 (4.83%)  20
Latent tuberculosis * 1  6/198 (3.03%)  6 12/195 (6.15%)  12 18/393 (4.58%)  18
Viral infection * 1  9/198 (4.55%)  12 7/195 (3.59%)  7 16/393 (4.07%)  19
Injury, poisoning and procedural complications       
Contusion * 1  15/198 (7.58%)  21 9/195 (4.62%)  10 24/393 (6.11%)  31
Investigations       
Alanine aminotransferase increased * 1  17/198 (8.59%)  23 15/195 (7.69%)  25 32/393 (8.14%)  48
Blood creatine phosphokinase increased * 1  15/198 (7.58%)  28 13/195 (6.67%)  25 28/393 (7.12%)  53
Aspartate aminotransferase increased * 1  9/198 (4.55%)  13 11/195 (5.64%)  17 20/393 (5.09%)  30
Gamma-glutamyltransferase increased * 1  8/198 (4.04%)  11 12/195 (6.15%)  15 20/393 (5.09%)  26
Musculoskeletal and connective tissue disorders       
Back pain * 1  24/198 (12.12%)  28 22/195 (11.28%)  26 46/393 (11.70%)  54
Psoriatic arthropathy * 1  24/198 (12.12%)  41 15/195 (7.69%)  23 39/393 (9.92%)  64
Arthralgia * 1  20/198 (10.10%)  28 18/195 (9.23%)  28 38/393 (9.67%)  56
Nervous system disorders       
Headache * 1  18/198 (9.09%)  19 17/195 (8.72%)  20 35/393 (8.91%)  39
Dizziness * 1  5/198 (2.53%)  5 10/195 (5.13%)  10 15/393 (3.82%)  15
Psychiatric disorders       
Depression * 1  11/198 (5.56%)  12 9/195 (4.62%)  12 20/393 (5.09%)  24
Respiratory, thoracic and mediastinal disorders       
Cough * 1  8/198 (4.04%)  9 14/195 (7.18%)  14 22/393 (5.60%)  23
Oropharyngeal pain * 1  6/198 (3.03%)  6 10/195 (5.13%)  13 16/393 (4.07%)  19
Skin and subcutaneous tissue disorders       
Psoriasis * 1  22/198 (11.11%)  31 19/195 (9.74%)  21 41/393 (10.43%)  52
Rash * 1  10/198 (5.05%)  16 9/195 (4.62%)  9 19/393 (4.83%)  25
Vascular disorders       
Hypertension * 1  30/198 (15.15%)  33 16/195 (8.21%)  20 46/393 (11.70%)  53
*
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: +1877 822 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: NCT01087788     History of Changes
Other Study ID Numbers: PsA001
2009-011720-59 ( EudraCT Number )
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: October 25, 2013
Results First Posted: February 25, 2014
Last Update Posted: August 1, 2018