Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT)

• ClinicalTrials.gov Identifier: NCT02346240
• Recruitment Status: Completed
• First Posted: January 26, 2015
• Results First Posted: July 18, 2018
• Last Update Posted: July 16, 2021
• Sponsor: UCB Biopharma S.P.R.L.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Placebo Q2W	Etanercept	CZP 200 mg Q2W	CZP 400 mg Q2W	Total Title
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
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%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
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

Outcome Measure Data

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)
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

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).

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).

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]

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]

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).

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).

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]

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
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

Outcome Measure Data

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)
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

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).

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).

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]

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
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

Outcome Measure Data

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)
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

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).

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).

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]

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
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

Outcome Measure Data

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)
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

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).

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).

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]

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
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

Outcome Measure Data

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)
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

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).

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).

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]

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
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

Outcome Measure Data

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)
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

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).

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).

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]

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
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

Outcome Measure Data

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)
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

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

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

Publications of Results:

Lebwohl M, Blauvelt A, Paul C, Sofen H, Weglowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.

Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17.

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

Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

• 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: July 16, 2021