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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2014-003492-36
    Trial protocol
    GB   DE   HU   CZ   NL   PL   BG   FR  
    Global end of trial date
    17 Dec 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    PS0003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02346240
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of certolizumab pegol (CZP) administered subcutaneously (sc) at the doses of CZP 400 mg every 2 weeks (Q2W) and CZP 200 mg Q2W after a loading dose of CZP 400 mg Q2W at Weeks 0, 2, and 4 to placebo in the treatment of moderate to severe chronic plaque psoriasis (PSO).
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy/concomitant medication was permitted as defined in the study protocol.
    Evidence for comparator
    Etanercept (ETN) is a fusion protein consisting of the fragment crystallizable (Fc) fragment of Immunoglobulin G1 (IgG1) with the Type 2 soluble Tumor Necrosis Factor (TNF) alpha receptor. ETN is specific for TNF alpha and lymphotoxin alpha. ETN was the first TNF alpha inhibitor approved for the treatment of psoriasis and is part of the standard armamentarium. The approved initial dose is 50 milligrams (mg) twice weekly. The safety and efficacy profile of ETN is well established. The first approval worldwide for ETN was in the United States in 1998 for the treatment of rheumatoid arthritis and in 2004 for psoriasis. All of these factors make ETN an ideal active comparator in this study.
    Actual start date of recruitment
    11 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Czech Republic: 80
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 63
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 233
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    United States: 92
    Worldwide total number of subjects
    559
    EEA total number of subjects
    467
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    519
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    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
    Screening 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.

    Period 1
    Period 1 title
    Initial Period (Baseline to Week 16)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    CZP and placebo treatments were administered in a double-blind fashion (the sponsor, subject, and blinded site staff remained blinded to treatment assignment during the first 16 weeks of the study). Etanercept treatments were administered in a single-blind fashion (the sponsor and the blinded site staff remained blinded, but the subject and unblinded study staff knew the treatment assignment during the first 16 weeks of the study).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Q2W
    Arm 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.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Arm title
    Etanercept
    Arm description
    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.
    Arm type
    Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    ETN
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 50 mg twice weekly

    Arm title
    CZP 200 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Number of subjects in period 1
    Placebo Q2W Etanercept CZP 200 mg Q2W CZP 400 mg Q2W
    Started
    57
    170
    165
    167
    Completed Week 16
    55
    159
    159
    162
    Finished Wk16 started Maintenance Period
    55
    159
    159
    160
    Completed
    55
    159
    159
    160
    Not completed
    2
    11
    6
    7
         Protocol deviation
    -
    1
    -
    -
         Subject missed 3 visits
    -
    -
    1
    -
         Non-compliance
    -
    1
    -
    1
         Lack of efficacy
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    4
    1
    1
         Consent withdrawn by subject
    1
    2
    3
    2
         Lost to follow-up
    1
    2
    1
    3
    Period 2
    Period 2 title
    Maintenance Period (Week 16 to Week 48)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor, Carer
    Blinding implementation details
    Participants who entered the escape arms of the study received open-label CZP 400 mg every 2 weeks. Participants who relapsed were removed from the placebo-controlled Maintenance Period and entered the OLE Period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Placebo Q2W
    Arm 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).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Arm title
    Etanercept/Placebo Q2W
    Arm description
    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).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    ETN
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 50 mg twice weekly

    Arm title
    Etanercept/CZP 200 mg Q2W
    Arm description
    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).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    ETN
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 50 mg twice weekly

    Arm title
    CZP 200 mg Q2W/Placebo Q2W
    Arm description
    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).
    Arm type
    Placebo

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Arm title
    CZP 200 mg Q2W/CZP 200 mg Q2W
    Arm description
    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).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 200 mg Q2W/CZP 400 mg Q4W
    Arm description
    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).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W/Placebo Q2W
    Arm description
    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).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W/CZP 200 mg Q2W
    Arm description
    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).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W/CZP 400 mg Q2W
    Arm description
    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).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    Placebo Q2W/Escape CZP 400 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Arm title
    Etanercept/Escape CZP 400 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    ETN
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 50 mg twice weekly

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 200 mg Q2W/Escape CZP 400 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W/Escape CZP 400 mg Q2W
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Number of subjects in period 2
    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
    Started
    2
    24
    50
    22
    44
    44
    25
    50
    49
    53
    85
    49
    36
    Completed Maintenance Period
    2
    23
    48
    20
    40
    43
    23
    47
    49
    46
    71
    36
    30
    Finished Wk48 entered Open-label Period
    2
    23
    48
    20
    40
    43
    23
    47
    49
    45
    68
    35
    29
    Completed
    2
    23
    48
    20
    40
    43
    23
    47
    49
    45
    68
    35
    29
    Not completed
    0
    1
    2
    2
    4
    1
    2
    3
    0
    8
    17
    14
    7
         Patient’s decisions
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Moved out of state
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lack of efficacy
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    3
    -
         Patient request due to non-compliance
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Unavailability due to business trip
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Withdrawn by Sponsor
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Did not achieve PASI50
    -
    -
    -
    -
    -
    -
    -
    -
    -
    3
    3
    8
    4
         Adverse event, non-fatal
    -
    -
    -
    1
    2
    -
    -
    -
    -
    1
    4
    1
    2
         Adverse events and alcohol problem
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Sponsor decision due to non-compliance
    -
    -
    -
    -
    1
    -
    -
    1
    -
    1
    1
    -
    -
         Consent withdrawn by subject
    -
    1
    1
    1
    1
    -
    1
    2
    -
    2
    5
    2
    1
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    Period 3
    Period 3 title
    Open-Label Period (Week 48 to Week 144)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/CZP 200 mg Q2W OLE
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 200 mg Q2W/CZP 200 mg Q2W OLE
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q4W/CZP 200 mg Q2W OLE
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    CZP 400 mg Q2W/CZP 200 mg Q2W OLE
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Arm description
    This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    Placebo/CZP 400 mg Q2W OLE
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections every 2 weeks (Q2W)

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Arm title
    Any CZP/CZP 400 mg Q2W OLE
    Arm description
    This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg every 2 weeks (Q2W) or 400 mg Q2W

    Number of subjects in period 3
    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
    Started
    34
    122
    41
    48
    177
    34
    16
    Completed
    31
    105
    34
    45
    146
    27
    8
    Not completed
    3
    17
    7
    3
    31
    7
    8
         Protocol deviation
    -
    -
    -
    -
    1
    -
    -
         Lack of efficacy
    -
    1
    -
    -
    1
    -
    -
         Adverse event, serious fatal
    -
    1
    1
    -
    1
    -
    -
         No efficacy of study medication
    -
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    6
    2
    3
    13
    3
    3
         Consent withdrawn by subject
    -
    4
    1
    -
    10
    1
    1
         No PASI50 response
    -
    2
    -
    -
    4
    2
    3
         Lost to follow-up
    2
    2
    3
    -
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Q2W
    Reporting 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.

    Reporting group title
    Etanercept
    Reporting group description
    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.

    Reporting group title
    CZP 200 mg Q2W
    Reporting group description
    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.

    Reporting group title
    CZP 400 mg Q2W
    Reporting group description
    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.

    Reporting group values
    Placebo Q2W Etanercept CZP 200 mg Q2W CZP 400 mg Q2W Total
    Number of subjects
    57 170 165 167 559
    Age categorical
    Units: Subjects
        <=18 years
    0 1 0 2 3
        Between 18 and 65 years
    53 156 153 154 516
        >=65 years
    4 13 12 11 40
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.5 ± 12.5 44.6 ± 14.1 46.7 ± 13.5 45.4 ± 12.4 -
    Gender categorical
    Units: Subjects
        Female
    23 43 52 60 178
        Male
    34 127 113 107 381
    Subject analysis sets

    Subject analysis set title
    Placebo Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set 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).

    Subject analysis set title
    Etanercept (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    Placebo/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set 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).

    Subject analysis set title
    Etanercept/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    Etanercept/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Subject analysis set title
    CZP 400 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Subject analysis sets values
    Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS) 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) CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Number of subjects
    57
    170
    165
    167
    2
    24
    50
    22
    44
    44
    25
    50
    49
    373
    412
    Age categorical
    Units: Subjects
        <=18 years
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    3
        Between 18 and 65 years
    53
    156
    153
    154
    2
    24
    47
    21
    43
    38
    24
    45
    45
    346
    377
        >=65 years
    4
    13
    12
    11
    0
    0
    3
    1
    1
    6
    0
    4
    4
    25
    32
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.5 ± 12.5
    44.6 ± 14.1
    46.7 ± 13.5
    45.4 ± 12.4
    41.5 ± 26.2
    47.2 ± 13.5
    43.3 ± 12.9
    47.3 ± 14.9
    43.2 ± 12.4
    49.4 ± 15.1
    42.9 ± 9.7
    43.3 ± 11.9
    44.6 ± 13.0
    45.3 ± 13.0
    45.8 ± 13.2
    Gender categorical
    Units: Subjects
        Female
    23
    43
    52
    60
    2
    6
    13
    7
    14
    14
    11
    18
    17
    115
    131
        Male
    34
    127
    113
    107
    0
    18
    37
    15
    30
    30
    14
    32
    32
    258
    281

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q2W
    Reporting 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.

    Reporting group title
    Etanercept
    Reporting group description
    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.

    Reporting group title
    CZP 200 mg Q2W
    Reporting group description
    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.

    Reporting group title
    CZP 400 mg Q2W
    Reporting group description
    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.
    Reporting group title
    Placebo/Placebo Q2W
    Reporting 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).

    Reporting group title
    Etanercept/Placebo Q2W
    Reporting group description
    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).

    Reporting group title
    Etanercept/CZP 200 mg Q2W
    Reporting group description
    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).

    Reporting group title
    CZP 200 mg Q2W/Placebo Q2W
    Reporting group description
    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).

    Reporting group title
    CZP 200 mg Q2W/CZP 200 mg Q2W
    Reporting group description
    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).

    Reporting group title
    CZP 200 mg Q2W/CZP 400 mg Q4W
    Reporting group description
    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).

    Reporting group title
    CZP 400 mg Q2W/Placebo Q2W
    Reporting group description
    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).

    Reporting group title
    CZP 400 mg Q2W/CZP 200 mg Q2W
    Reporting group description
    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).

    Reporting group title
    CZP 400 mg Q2W/CZP 400 mg Q2W
    Reporting group description
    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).

    Reporting group title
    Placebo Q2W/Escape CZP 400 mg Q2W
    Reporting group description
    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.

    Reporting group title
    Etanercept/Escape CZP 400 mg Q2W
    Reporting group description
    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.

    Reporting group title
    CZP 200 mg Q2W/Escape CZP 400 mg Q2W
    Reporting group description
    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.

    Reporting group title
    CZP 400 mg Q2W/Escape CZP 400 mg Q2W
    Reporting group description
    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.
    Reporting group title
    Placebo/CZP 200 mg Q2W OLE
    Reporting group description
    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.

    Reporting group title
    CZP 200 mg Q2W/CZP 200 mg Q2W OLE
    Reporting group description
    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.

    Reporting group title
    CZP 400 mg Q4W/CZP 200 mg Q2W OLE
    Reporting group description
    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.

    Reporting group title
    CZP 400 mg Q2W/CZP 200 mg Q2W OLE
    Reporting group description
    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.

    Reporting group title
    Esc CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.

    Reporting group title
    Placebo/CZP 400 mg Q2W OLE
    Reporting group description
    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.

    Reporting group title
    Any CZP/CZP 400 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who relapsed on CZP 200 mg Q2W, CZP 400 mg Q4W and 400 mg Q2W.

    Subject analysis set title
    Placebo Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set 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).

    Subject analysis set title
    Etanercept (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    Placebo/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set 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).

    Subject analysis set title
    Etanercept/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    Etanercept/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/Placebo Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    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).

    Subject analysis set title
    CZP 200 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Subject analysis set title
    CZP 400 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 12

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    End point title
    Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 12
    End point 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.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    170
    165
    167
    Units: percentage of participants
        number (not applicable)
    5.0
    53.3
    61.3
    66.7
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    61.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.1
         upper limit
    71.2
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    56.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.4
         upper limit
    66
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [1]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    37.988
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.312
         upper limit
    127.576
    Notes
    [1] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    30.023
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.971
         upper limit
    100.481
    Notes
    [2] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.
    Statistical analysis title
    Statistical Analysis 5
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Etanercept (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    13.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.7
         upper limit
    24.1
    Statistical analysis title
    Statistical Analysis 6
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Etanercept (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    18.9
    Statistical analysis title
    Statistical Analysis 7
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Etanercept (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0152 [3]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.756
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.114
         upper limit
    2.768
    Notes
    [3] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.
    Statistical analysis title
    Statistical Analysis 8
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Etanercept (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1523 [4]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.388
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.886
         upper limit
    2.175
    Notes
    [4] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN

    Secondary: 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

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    End point 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
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    170
    165
    167
    Units: percentage of participants
        number (not applicable)
    1.9
    39.2
    39.8
    50.3
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    48.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    39.33
         upper limit
    57.63
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    37.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.88
         upper limit
    46.96
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [5]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    56.129
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.787
         upper limit
    404.555
    Notes
    [5] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0004 [6]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    36.566
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.061
         upper limit
    264.196
    Notes
    [6] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

    Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 12

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    End point title
    Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 12
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Q2W (RS) Etanercept (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    170
    165
    167
    Units: percentage of participants
        number (not applicable)
    0.2
    27.1
    31.2
    34.0
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    33.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.68
         upper limit
    46.98
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.18
         upper limit
    43.8
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [7]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    39.949
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.407
         upper limit
    189.828
    Notes
    [7] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [8]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    35.084
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.363
         upper limit
    167.179
    Notes
    [8] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

    Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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    End point title
    Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    165
    167
    Units: percentage of participants
        number (not applicable)
    3.8
    68.2
    74.7
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    70.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    62.15
         upper limit
    79.59
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    64.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.12
         upper limit
    73.63
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [9]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    76.277
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.952
         upper limit
    324.094
    Notes
    [9] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [10]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    55.413
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.135
         upper limit
    233.782
    Notes
    [10] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

    Secondary: 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

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    End point 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
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    165
    167
    Units: percentage of participants
        number (not applicable)
    3.4
    48.3
    58.4
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    45.59
         upper limit
    64.35
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    44.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.39
         upper limit
    54.49
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [11]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    40.717
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.741
         upper limit
    170.198
    Notes
    [11] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [12]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    27.165
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.504
         upper limit
    113.453
    Notes
    [12] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

    Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

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    End point title
    Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    57
    165
    167
    Units: percentage of participants
        number (not applicable)
    0.3
    39.8
    49.1
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    48.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.22
         upper limit
    63.41
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    39.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.58
         upper limit
    53.38
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [13]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    72.278
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.65
         upper limit
    356.602
    Notes
    [13] - The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [14]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    49.527
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.002
         upper limit
    245.256
    Notes
    [14] - The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

    Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48 for those achieving PASI75 at Week 16

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    End point title
    Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48 for those achieving PASI75 at Week 16
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    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)
    Number of subjects analysed
    2
    24
    50
    22
    44
    44
    25
    50
    49
    Units: percentage of participants
        number (not applicable)
    100
    8.3
    82.0
    45.5
    79.5
    88.6
    36.0
    80.0
    98.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.
    Adverse event reporting additional description
    At Week 16, most PBO-randomized participants escaped to CZP 400 mg Q2W and all ETN-randomized participants switched to PBO or CZP, leading to a significantly lower exposure in PBO/ETN arms than in CZP arms. Considering the limitations of such comparison, AEs reported while the participants were on PBO or ETN are not included in this summary.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    CZP 200 mg Q2W (TCS)
    Reporting group description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Reporting group title
    CZP 400 mg Q2W (TCS)
    Reporting group description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Serious adverse events
    CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 373 (9.92%)
    51 / 412 (12.38%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anaplastic oligodendroglioma
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    House dust allergy
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion missed
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy with contraceptive
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar I disorder
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical polyp
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 373 (0.27%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cyst
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extradural haematoma
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 373 (0.00%)
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 373 (0.27%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Mycobacterium tuberculosis complex test negative
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Intracardiac mass
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 373 (0.54%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 373 (0.00%)
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary progressive multiple sclerosis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 373 (0.27%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guttate psoriasis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pustular psoriasis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Sacroiliitis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 373 (0.80%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreas infection
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    1 / 373 (0.27%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 373 (0.27%)
    2 / 412 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 373 (0.27%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 373 (0.27%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 373 (0.00%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    150 / 373 (40.21%)
    159 / 412 (38.59%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    20 / 373 (5.36%)
    24 / 412 (5.83%)
         occurrences all number
    21
    24
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    17 / 373 (4.56%)
    18 / 412 (4.37%)
         occurrences all number
    20
    20
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    18 / 373 (4.83%)
    18 / 412 (4.37%)
         occurrences all number
    21
    19
    Upper respiratory tract infection
         subjects affected / exposed
    39 / 373 (10.46%)
    45 / 412 (10.92%)
         occurrences all number
    58
    64
    Nasopharyngitis
         subjects affected / exposed
    57 / 373 (15.28%)
    66 / 412 (16.02%)
         occurrences all number
    84
    83
    Viral upper respiratory tract infection
         subjects affected / exposed
    23 / 373 (6.17%)
    11 / 412 (2.67%)
         occurrences all number
    38
    13

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2015
    Global Protocol Amendment 1 incorporated the country-specific amendments in the UK (Amendments 0.1 and 0.5), the Czech Republic (Amendment 0.2), Germany (Amendment 0.3), and France (Amendment 0.4). In addition, the following changes were made: •Updated study contact information. •The treatment received in Period 3 was based on initial treatment and response to treatment at Week 16. All CZP and Placebo (PBO) treatments were to be administered by dedicated unblinded site personnel at site visits. -Subjects initially randomized to CZP 200 mg Q2W were rerandomized (2:2:1) to receive either CZP 200 mg Q2W or CZP 400 mg Q4W (with PBO administered on alternate dosing weeks to maintain the blind) or PBO •Etanercept (ETN) treatments were allowed to be administered by trained study staff on site or outside of the study center (to allow flexibility around self-administration). If ETN was self-administered, compliance was to be recorded on a drug administration log by the subject and data were to be entered into the electronic Case Report form (eCRF) by study personnel. The percentage of doses missed (2 or more doses changed to 25% or more of the doses) was updated; ETN was administered more frequently than CZP or placebo during the Initial Treatment Period. •The number of planned sites was increased (from 50 to 67) and Australia and Canada were removed. •Exclusion Criterion #6 was clarified to include latex hypersensitivity. •Changes were made to drug accountability to allow for on-site destruction with prior Sponsor approval. •Secukinumab was added as a prohibited concomitant treatment. •Stratification across sites based on prior biologic use was eliminated. •Text describing the modified Nail Psoriasis Severity Index (mNAPSI) was updated. •Elispot testing for tuberculosis was removed. The chest x-ray required at screening was not needed if an x-ray had already been performed within 3 months of screening. •A center-by-treatment interaction analysis was added and described.
    23 Dec 2015
    Global Protocol Amendment 2 included the following changes: •CIMPACT (name of the PS0003 protocol) was added. •Updated study contact information. •Having at least a 90% reduction from Baseline in Psoriasis Area and Severity Index (PASI90) at Weeks 12 and 16 were added as secondary efficacy variables and PASI90 at Week 12 was included in the sequential testing procedure for the efficacy analysis. •Added time to onset of PASI90 as an efficacy variable. Deleted time to loss of PASI75 response at Week 16. Added EQ-5D-Visual Analog Scale (VAS) (inadvertently omitted in previous protocol). •Clarified the dosing period during the Initial Treatment Period, assessments performed, and use of unblinded study staff for drug administration. •Clarified study medication administration in Open-label Extension (OLE) Treatment Period. •Added secukinumab 24 weeks prior to the Baseline Visit as an exclusion for prior treatment. •Clarified the withdrawal criteria and addition of a withdrawal criterion to be consistent with the study population. See Exclusion Criterion #6. •Text was added to clarify that the unblinded team at the site was to transition their activities once the Week 48 visits (blinded Maintenance Treatment Period) were completed. •Clarified prohibited concomitant medications and therapies. •Added a window for the Safety Follow-Up (SFU) Visit (10 weeks after final dose); the visit should have occurred no more than 3 days prior to the scheduled visit date and within 14 days after the scheduled visit date (-3 days/+14 days). •Addition of a “Treated with CZP Set” (TCS) to further assess the safety of CZP in subjects with PSO. Addition of a Maintenance Set (MS) to further assess the efficacy and safety of CZP in long-term treatment of PSO.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29660425
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