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Trial record 1 of 1 for:    NCT02346240
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Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT)

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: NCT02346240
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : July 18, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Psoriasis
Plaque Psoriasis
Interventions Biological: Certolizumab Pegol
Biological: Etanercept
Other: Placebo
Enrollment 559
Recruitment Details This study started to enroll participants in February 2015, from multiple sites in Europe and United States and concluded in December 2018. 559 participants are included in the Randomized Set (RS) shown in the Participant Flow.
Pre-assignment Details The study included a Screening Period, an Initial Treatment Period up to Week 16, a Maintenance Treatment Period up to Week 48, an Open-Label Extension Treatment Period up to Week 144 and a Safety Follow-up Period up to Week 157. The Participants Flow refers to the Randomized Set, the Maintenance Set and the Open Label Set.
Arm/Group Title Placebo Q2W Etanercept CZP 200 mg Q2W CZP 400 mg Q2W Placebo/Placebo Q2W Etanercept/Placebo Q2W Etanercept/CZP 200 mg Q2W CZP 200 mg Q2W/Placebo Q2W CZP 200 mg Q2W/CZP 200 mg Q2W CZP 200 mg Q2W/CZP 400 mg Q4W CZP 400 mg Q2W/Placebo Q2W CZP 400 mg Q2W/CZP 200 mg Q2W CZP 400 mg Q2W/CZP 400 mg Q2W Placebo Q2W/Escape CZP 400 mg Q2W Etanercept/Escape CZP 400 mg Q2W CZP 200 mg Q2W/Escape CZP 400 mg Q2W CZP 400 mg Q2W/Escape CZP 400 mg Q2W Placebo/CZP 200 mg Q2W OLE CZP 200 mg Q2W/CZP 200 mg Q2W OLE CZP 400 mg Q4W/CZP 200 mg Q2W OLE CZP 400 mg Q2W/CZP 200 mg Q2W OLE Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE Placebo/CZP 400 mg Q2W OLE Any CZP/CZP 400 mg Q2W OLE
Hide Arm/Group Description

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.

•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants initially randomized in the Etanercept arm, who did not achieve a PASI75 response at Week 16 escaped from the treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants initially randomized in the CZP 200 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants initially randomized in the CZP 400 mg arm, who did not achieve a PASI75 response at Week 16 escaped from the blinded treatment and received CZP 400 mg every two weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants from the Placebo-controlled Maintenance Period, who achieved PASI50 response (had no relapse) at Week 48 and entered the 96-Weeks OLE Period receiving CZP 200 mg Q2W. This arm consisted of participants who received CZP 200 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE. This arm consisted of participants who received CZP 400 mg Q4W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose. This arm consisted of participants who received CZP 400 mg Q2W in the Maintenance Period, who achieved a PASI50 response (had no relapse) at Week 48 and entered OLE on the CZP 200mg Q2W dose. This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE. This arm consisted of participants from the Placebo-controlled Maintenance Period, who did not achieve PASI50 response (had relapse) and entered the 96-weeks OLE Period receiving CZP 400 mg Q2W. This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.
Period Title: Initial Period (Baseline to Week 16)
Started 57 170 165 167 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed Week 16 55 159 159 162 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Finished Wk16 Started Maintenance Period 55 159 159 160 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 55 159 159 160 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 2 11 6 7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             4             1             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             1             2             1             3             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             1             2             3             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Non-compliance             0             1             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Subject missed 3 visits             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: Maintenance Period (Week 16 to Week 48)
Started 0 0 0 0 2 24 50 22 44 44 25 50 49 53 85 49 36 0 0 0 0 0 0 0
Completed Maintenance Period 0 0 0 0 2 23 48 20 40 43 23 47 49 46 71 36 30 0 0 0 0 0 0 0
Finished Wk48 Entered Open-label Period 0 0 0 0 2 23 48 20 40 43 23 47 49 45 68 35 29 0 0 0 0 0 0 0
Completed 0 0 0 0 2 23 48 20 40 43 23 47 49 45 [1] 68 [2] 35 [1] 29 [1] 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 1 2 2 4 1 2 3 0 8 17 14 7 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             2             0             0             0             0             1             4             1             2             0             0             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             3             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             1             1             1             0             1             2             0             2             5             2             1             0             0             0             0             0             0             0
Did not achieve PASI50             0             0             0             0             0             0             0             0             0             0             0             0             0             3             3             8             4             0             0             0             0             0             0             0
Moved out of state             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Sponsor decision due to non-compliance             0             0             0             0             0             0             0             0             1             0             0             1             0             1             1             0             0             0             0             0             0             0             0             0
Adverse events and alcohol problem             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Patient's decisions             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Unavailability due to business trip             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
Withdrawn by Sponsor             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
Patient request due to non-compliance             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
[1]
1 subject completed the Maintenance Period but did not enter the Open-Label Period.
[2]
3 subjects completed the Maintenance Period but did not enter the Open-Label Period.
Period Title: Open-Label Period (Week 48 to Week 144)
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 34 122 41 48 177 34 16
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 31 105 34 45 146 27 8
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 17 7 3 31 7 8
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             6             2             3             13             3             3
Death             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1             0             1             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             1             0             0
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             2             3             0             1             1             1
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             4             1             0             10             1             1
No PASI50 response             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0             0             4             2             3
No efficacy of study medication             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0
Arm/Group Title Placebo Q2W Etanercept CZP 200 mg Q2W CZP 400 mg Q2W Total Title
Hide Arm/Group Description

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.

•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

[Not Specified]
Overall Number of Baseline Participants 57 170 165 167 559
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set consisting of all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 170 participants 165 participants 167 participants 559 participants
<=18 years
0
   0.0%
1
   0.6%
0
   0.0%
2
   1.2%
3
   0.5%
Between 18 and 65 years
53
  93.0%
156
  91.8%
153
  92.7%
154
  92.2%
516
  92.3%
>=65 years
4
   7.0%
13
   7.6%
12
   7.3%
11
   6.6%
40
   7.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 170 participants 165 participants 167 participants 559 participants
46.5  (12.5) 44.6  (14.1) 46.7  (13.5) 45.4  (12.4) 45.7  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 170 participants 165 participants 167 participants 559 participants
Female
23
  40.4%
43
  25.3%
52
  31.5%
60
  35.9%
178
  31.8%
Male
34
  59.6%
127
  74.7%
113
  68.5%
107
  64.1%
381
  68.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 170 participants 165 participants 167 participants 559 participants
Asian
0
   0.0%
1
   0.6%
3
   1.8%
3
   1.8%
7
   1.3%
Black or African American
0
   0.0%
3
   1.8%
2
   1.2%
2
   1.2%
7
   1.3%
White
57
 100.0%
163
  95.9%
158
  95.8%
162
  97.0%
540
  96.6%
Other/mixed
0
   0.0%
3
   1.8%
2
   1.2%
0
   0.0%
5
   0.9%
1.Primary Outcome
Title Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.

•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 170 165 167
Measure Type: Number
Unit of Measure: percentage of participants
5.0 53.3 61.3 66.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 61.6
Confidence Interval (2-Sided) 95%
52.1 to 71.2
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 56.2
Confidence Interval (2-Sided) 95%
46.4 to 66.0
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 37.988
Confidence Interval (2-Sided) 95%
11.312 to 127.576
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 30.023
Confidence Interval (2-Sided) 95%
8.971 to 100.481
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
2.7 to 24.1
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
-2.9 to 18.9
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etanercept (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0152
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.756
Confidence Interval (2-Sided) 95%
1.114 to 2.768
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Etanercept (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.1523
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.388
Confidence Interval (2-Sided) 95%
0.886 to 2.175
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12
Hide Description The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.

•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 170 165 167
Measure Type: Number
Unit of Measure: percentage of participants
1.9 39.2 39.8 50.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 48.5
Confidence Interval (2-Sided) 95%
39.33 to 57.63
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 37.9
Confidence Interval (2-Sided) 95%
28.88 to 46.96
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 56.129
Confidence Interval (2-Sided) 95%
7.787 to 404.555
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0004
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 36.566
Confidence Interval (2-Sided) 95%
5.061 to 264.196
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
Hide Description The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5.

•PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 170 165 167
Measure Type: Number
Unit of Measure: percentage of participants
0.2 27.1 31.2 34.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 33.8
Confidence Interval (2-Sided) 95%
20.68 to 46.98
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 31.0
Confidence Interval (2-Sided) 95%
18.18 to 43.80
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 39.949
Confidence Interval (2-Sided) 95%
8.407 to 189.828
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 35.084
Confidence Interval (2-Sided) 95%
7.363 to 167.179
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 165 167
Measure Type: Number
Unit of Measure: percentage of participants
3.8 68.2 74.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 70.9
Confidence Interval (2-Sided) 95%
62.15 to 79.59
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 64.4
Confidence Interval (2-Sided) 95%
55.12 to 73.63
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 76.277
Confidence Interval (2-Sided) 95%
17.952 to 324.094
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 55.413
Confidence Interval (2-Sided) 95%
13.135 to 233.782
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16
Hide Description The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 165 167
Measure Type: Number
Unit of Measure: percentage of participants
3.4 48.3 58.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 55.0
Confidence Interval (2-Sided) 95%
45.59 to 64.35
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 44.9
Confidence Interval (2-Sided) 95%
35.39 to 54.49
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 40.717
Confidence Interval (2-Sided) 95%
9.741 to 170.198
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 27.165
Confidence Interval (2-Sided) 95%
6.504 to 113.453
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
Hide Description The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description

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

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.

Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:

•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.

Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.

Participants formed the Randomized Set (RS).

Overall Number of Participants Analyzed 57 165 167
Measure Type: Number
Unit of Measure: percentage of participants
0.3 39.8 49.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 48.8
Confidence Interval (2-Sided) 95%
34.22 to 63.41
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 39.5
Confidence Interval (2-Sided) 95%
25.58 to 53.38
Estimation Comments Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 72.278
Confidence Interval (2-Sided) 95%
14.650 to 356.602
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
Method Regression, Logistic
Comments Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 49.527
Confidence Interval (2-Sided) 95%
10.002 to 245.256
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period.

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

Arm/Group Title Placebo/Placebo Q2W (WK16RS) Etanercept/Placebo Q2W (WK16RS) Etanercept/CZP 200 mg Q2W (WK16RS) CZP 200 mg Q2W/Placebo Q2W (WK16RS) CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) CZP 400 mg Q2W/Placebo Q2W (WK16RS) CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)
Hide Arm/Group Description:
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Overall Number of Participants Analyzed 2 24 50 22 44 44 25 50 49
Measure Type: Number
Unit of Measure: percentage of participants
100 8.3 82.0 45.5 79.5 88.6 36.0 80.0 98.0
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.
Adverse Event Reporting Description At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
 
Arm/Group Title Placebo Q2W (SS) Wk 0-48 Etanercept (SS) Wk 0-12 CZP 200 mg Q2W (SS) Wk 0-144 CZP 400 mg Q2W (SS) Wk 0-144 CZP 400mg Q4W (SS) Wk 16-48
Hide Arm/Group Description

This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48).

Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS).

This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12).

Participants formed the SS.

This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144).

Participants formed the SS.

This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144).

Participants formed the SS.

This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48).

Participants formed the SS.

All-Cause Mortality
Placebo Q2W (SS) Wk 0-48 Etanercept (SS) Wk 0-12 CZP 200 mg Q2W (SS) Wk 0-144 CZP 400 mg Q2W (SS) Wk 0-144 CZP 400mg Q4W (SS) Wk 16-48
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)      0/168 (0.00%)      2/373 (0.54%)      1/412 (0.24%)      0/44 (0.00%)    
Hide Serious Adverse Events
Placebo Q2W (SS) Wk 0-48 Etanercept (SS) Wk 0-12 CZP 200 mg Q2W (SS) Wk 0-144 CZP 400 mg Q2W (SS) Wk 0-144 CZP 400mg Q4W (SS) Wk 16-48
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/128 (6.25%)      1/168 (0.60%)      34/373 (9.12%)      51/412 (12.38%)      5/44 (11.36%)    
Cardiac disorders           
Intracardiac mass * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Coronary artery disease * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Cardiac failure * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Acute coronary syndrome * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Acute myocardial infarction * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Angina pectoris * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Ear and labyrinth disorders           
Vestibular disorder * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Tympanic membrane perforation * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Eye disorders           
Cataract * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Retinal detachment * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Gastrointestinal disorders           
Large intestine polyp * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Crohn's disease * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Abdominal pain * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Haemorrhoidal haemorrhage * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Haemorrhoids * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Inguinal hernia * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 1/44 (2.27%)  1
Upper gastrointestinal haemorrhage * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Peptic ulcer * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Umbilical hernia * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
General disorders           
Inflammation * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Systemic inflammatory response syndrome * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Nodule * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  2 0/44 (0.00%)  0
Vascular stent thrombosis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Liver disorder * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Acute hepatic failure * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Hepatitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Immune system disorders           
Sarcoidosis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
House dust allergy * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Infections and infestations           
Appendiceal abscess * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Appendicitis perforated * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Gastroenteritis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Pancreas infection * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 1/44 (2.27%)  1
Rectal abscess * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Cellulitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Osteomyelitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Pseudomembranous colitis * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Escherichia sepsis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Endophthalmitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 1/412 (0.24%)  1 0/44 (0.00%)  0
Pneumonia klebsiella * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Pneumonia * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 2/412 (0.49%)  2 1/44 (2.27%)  1
Bronchitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 1/412 (0.24%)  1 0/44 (0.00%)  0
Bacteraemia * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Sepsis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Pyoderma * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Subcutaneous abscess * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Erysipelas * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Tuberculosis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Pyelonephritis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Injury, poisoning and procedural complications           
Meniscus injury * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  2 0/44 (0.00%)  0
Concussion * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Craniocerebral injury * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Extradural haematoma * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Wrist fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 2/412 (0.49%)  2 0/44 (0.00%)  0
Foot fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Forearm fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 1/44 (2.27%)  1
Lower limb fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Radius fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Ulna fracture * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Ligament rupture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Laceration * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Facial bones fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Rib fracture * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 1/412 (0.24%)  1 0/44 (0.00%)  0
Investigations           
Hepatic enzyme increased * 1  1/128 (0.78%)  1 1/168 (0.60%)  1 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Mycobacterium tuberculosis complex test negative * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Blood creatine phosphokinase increased * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Metabolism and nutrition disorders           
Obesity * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  2 0/44 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Sacroiliitis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Spinal pain * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Chondropathy * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Polymyalgia rheumatica * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Back pain * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Mobility decreased * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Compartment syndrome * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Osteoarthritis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 3/373 (0.80%)  4 1/412 (0.24%)  1 0/44 (0.00%)  0
Psoriatic arthropathy * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anaplastic oligodendroglioma * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Glioblastoma * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Hodgkin's disease * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Laryngeal cancer * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Clear cell renal cell carcinoma * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Benign neoplasm of bladder * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Syncope * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Nervous system disorders           
Migraine * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 2/412 (0.49%)  2 0/44 (0.00%)  0
Primary progressive multiple sclerosis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Abortion * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Abortion missed * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Pregnancy on contraceptive * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Psychiatric disorders           
Bipolar I disorder * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Depression * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Renal and urinary disorders           
Urinary bladder haemorrhage * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Acute kidney injury * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Nephrolithiasis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Renal cyst * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Reproductive system and breast disorders           
Cervical polyp * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Metrorrhagia * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Ovarian cyst * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 1/412 (0.24%)  1 0/44 (0.00%)  0
Rectocele * 1  1/128 (0.78%)  1 0/168 (0.00%)  0 0/373 (0.00%)  0 0/412 (0.00%)  0 0/44 (0.00%)  0
Endometrial hyperplasia * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Uterine cyst * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Uterine polyp * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Chronic obstructive pulmonary disease * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 2/373 (0.54%)  3 0/412 (0.00%)  0 0/44 (0.00%)  0
Nasal septum deviation * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Pulmonary embolism * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Skin and subcutaneous tissue disorders           
Erythrodermic psoriasis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Guttate psoriasis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Psoriasis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Pustular psoriasis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Purpura * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Skin ulcer * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 1/373 (0.27%)  1 0/412 (0.00%)  0 0/44 (0.00%)  0
Vascular disorders           
Hypertensive crisis * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
Peripheral arterial occlusive disease * 1  0/128 (0.00%)  0 0/168 (0.00%)  0 0/373 (0.00%)  0 1/412 (0.24%)  1 0/44 (0.00%)  0
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Q2W (SS) Wk 0-48 Etanercept (SS) Wk 0-12 CZP 200 mg Q2W (SS) Wk 0-144 CZP 400 mg Q2W (SS) Wk 0-144 CZP 400mg Q4W (SS) Wk 16-48
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/128 (32.81%)      37/168 (22.02%)      139/373 (37.27%)      158/412 (38.35%)      11/44 (25.00%)    
Infections and infestations           
Nasopharyngitis * 1  15/128 (11.72%)  16 14/168 (8.33%)  14 56/373 (15.01%)  81 66/412 (16.02%)  83 3/44 (6.82%)  3
Upper respiratory tract infection * 1  13/128 (10.16%)  15 12/168 (7.14%)  14 38/373 (10.19%)  55 45/412 (10.92%)  64 3/44 (6.82%)  3
Viral upper respiratory tract infection * 1  2/128 (1.56%)  2 4/168 (2.38%)  4 23/373 (6.17%)  34 11/412 (2.67%)  13 2/44 (4.55%)  4
Investigations           
Blood creatine phosphokinase increased * 1  2/128 (1.56%)  2 2/168 (1.19%)  2 9/373 (2.41%)  10 12/412 (2.91%)  13 3/44 (6.82%)  5
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  3/128 (2.34%)  3 3/168 (1.79%)  3 14/373 (3.75%)  17 18/412 (4.37%)  20 3/44 (6.82%)  3
Skin and subcutaneous tissue disorders           
Psoriasis * 1  7/128 (5.47%)  7 1/168 (0.60%)  1 10/373 (2.68%)  10 20/412 (4.85%)  23 1/44 (2.27%)  1
Vascular disorders           
Hypertension * 1  7/128 (5.47%)  7 3/168 (1.79%)  4 19/373 (5.09%)  19 24/412 (5.83%)  24 2/44 (4.55%)  2
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02346240    
Other Study ID Numbers: PS0003
2014-003492-36 ( EudraCT Number )
First Submitted: January 20, 2015
First Posted: January 26, 2015
Results First Submitted: June 22, 2018
Results First Posted: July 18, 2018
Last Update Posted: April 13, 2020