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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2014-003307-30
    Trial protocol
    		 HU   SK   CZ   GB  
    Global end of trial date
    19 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2018
    First version publication date
    04 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RA0123
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02430909
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Celltech, UK Registered Branch of UCB Pharma SA
    Sponsor organisation address
    208 Bath Road, Slough, Berkshire, United Kingdom, SL1 3WE
    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
    06 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of bimekizumab (UCB4940) as an add-on therapy to certolizumab pegol (CZP) and background conventional disease-modifying anti-rheumatic drugs (DMARDs) compared to placebo plus CZP treatment and background conventional DMARDs and to evaluate the efficacy of bimekizumab as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs at Week 20
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    		 Background therapy as permitted in the protocol.
    Evidence for comparator
    		 No
    Actual start date of recruitment
    05 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Moldova, Republic of: 14
    Country: Number of subjects enrolled
    Poland: 54
    Country: Number of subjects enrolled
    Russian Federation: 73
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    159
    EEA total number of subjects
    72
    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)
    138
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started to enroll patients in May 2015 and concluded in April 2017. 288 subjects were included in the Screening Set. 129 subjects dropped screening and were excluded from the Safety Analysis Set.

    Pre-assignment
    Screening details
    		 The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CZP / CZP + PBO / CZP
    Arm description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18
    Arm type
    		 Placebo

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was supplied as 0.9 % sodium chloride aqueous solution for intravenous infusion from Week 8 to Week 18 in order to maintain the blinding.

    Arm title
    		 CZP / CZP + BKZ / CZP
    Arm description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimekizumab
    Investigational medicinal product code
    UCB4940
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Active investigational product (infusion solution containing 80 mg/mL UCB4940) administered as intravenous (iv) infusion starting at Week 8 with a 240 mg loading dose followed by 120 mg every 2 weeks.

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.

    Arm title
    		 CZP / CZP / CZP
    Arm description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30
    Arm type
    		 only CZP

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.

    Number of subjects in period 1
    		CZP / CZP + PBO / CZP CZP / CZP + BKZ / CZP CZP / CZP / CZP
    Started
    27
    52
    80
    Completed
    23
    43
    66
    Not completed
    4
    9
    14
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    1
    5
    2
         Adverse event, non-fatal
    2
    4
    8
         Pregnancy
    -
    -
    1
         Lost to follow-up
    -
    -
    1
         Sponsor decision
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CZP / CZP + PBO / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18

    Reporting group title
    CZP / CZP + BKZ / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18

    Reporting group title
    CZP / CZP / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30

    Reporting group values
    		 CZP / CZP + PBO / CZP CZP / CZP + BKZ / CZP CZP / CZP / CZP Total
    Number of subjects
    		 27 52 80 159
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 25 47 66 138
        From 65-84 years
    		 2 5 14 21
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ( 9.5 ) 51.7 ( 11.3 ) 55.1 ( 11.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 45 67 135
        Male
    		 4 7 13 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1 2
        Not Hispanic or Latino
    		 27 51 79 157
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 27 52 80 159
        More than one race
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    CZP / CZP + PBO / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18

    Reporting group title
    CZP / CZP + BKZ / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18

    Reporting group title
    CZP / CZP / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30

    Subject analysis set title
    CZP / CZP + PBO / CZP-SS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.

    Subject analysis set title
    CZP / CZP + BKZ / CZP-SS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.

    Subject analysis set title
    CZP / CZP / CZP-SS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.

    Subject analysis set title
    CZP / CZP + PBO / CZP-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.

    Subject analysis set title
    CZP / CZP + BKZ / CZP-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.

    Subject analysis set title
    CZP / CZP / CZP-FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.

    Primary: Incidence of Adverse Events

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    End point title
    		 Incidence of Adverse Events [1]
    End point description
    All adverse events (AEs) are recorded during the entire study period.
    End point type
    Primary
    End point timeframe
    From Baseline (Week 0) until final study visit (Week 44)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    		 CZP / CZP + PBO / CZP-SS CZP / CZP + BKZ / CZP-SS CZP / CZP / CZP-SS
    Number of subjects analysed
    27
    52
    80
    Units: percentage of participants
        number (not applicable)
    70.4
    82.7
    67.5
    No statistical analyses for this end point

    Primary: Change from Baseline 2 to Week 20 in DAS28(CRP)

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    End point title
    		 Change from Baseline 2 to Week 20 in DAS28(CRP) [2]
    End point description
    DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Primary
    End point timeframe
    Week 20
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The Bayesian model uses an informative prior distribution for the PBO+CZP group, vague priors for all other parameters. Fixed effect; treatment. Covariate; DAS28(CRP) at baseline 2. It is a pre-specified superiority analysis. 70 subjects were included in 2 comparison groups [CZP/CZP + PBO/CZP-FAS; CZP/CZP + BKZ/CZP-FAS]. The posterior probability of a difference from Placebo being greater than 0 was 99.4 %. Point estimate (Mean Difference (SD)): 0.58 (0.23); 95% Credible interval: [0.13, 1.05]
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS
    Number of subjects analysed
    24
    46
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.82 ( 0.17 )
    -1.41 ( 0.16 )
    No statistical analyses for this end point

    Secondary: Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2

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    End point title
    		 Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2
    End point description
    ACRn is the percentage improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS
    Number of subjects analysed
    24
    43
    Units: units on a scale
        arithmetic mean (standard deviation)
    17.03 ( 40.94 )
    19.21 ( 60.01 )
    No statistical analyses for this end point

    Secondary: ACR20 response based on Baseline 2

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    End point title
    		 ACR20 response based on Baseline 2
    End point description
    The assessments are based on a 20 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS
    Number of subjects analysed
    24
    43
    Units: percentage of responder
        number (not applicable)
    54.2
    60.5
    No statistical analyses for this end point

    Secondary: ACR50 response based on Baseline 2

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    End point title
    		 ACR50 response based on Baseline 2
    End point description
    The assessments are based on a 50 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS
    Number of subjects analysed
    24
    43
    Units: percentage of responder
        number (not applicable)
    8.3
    34.9
    No statistical analyses for this end point

    Secondary: ACR70 response based on Baseline 2

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    End point title
    		 ACR70 response based on Baseline 2
    End point description
    The assessments are based on a 70 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS
    Number of subjects analysed
    24
    43
    Units: percentage of responder
        number (not applicable)
    0
    14.0
    No statistical analyses for this end point

    Secondary: DAS28(CRP) remission at Week 20

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    End point title
    		 DAS28(CRP) remission at Week 20
    End point description
    DAS28(CRP) remission is defined as DAS28(CRP) < 2.6. DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28) , the C-reactive protein value and the patient global assessment of disease activity.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 CZP / CZP + PBO / CZP-FAS CZP / CZP + BKZ / CZP-FAS CZP / CZP / CZP-FAS
    Number of subjects analysed
    24
    46
    68
    Units: percentage of remitter
        number (not applicable)
    8.3
    26.1
    52.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected during the whole study from Study Start (Day 1) until Safety Follow-Up or Withdrawal Visit (up to Week 44)
    Adverse event reporting additional description
    For the incidence of Treatment-Emergent Adverse Events (TEAEs) by Relationship, related is defined as related to bimekizumab (BKZ)/placebo and/or related to certolizumab pegol (CZP).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    CZP / CZP + PBO / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18

    Reporting group title
    CZP / CZP + BKZ / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18

    Reporting group title
    CZP / CZP / CZP
    Reporting group description
    		 Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30

    Serious adverse events
    		 CZP / CZP + PBO / CZP CZP / CZP + BKZ / CZP CZP / CZP / CZP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 27 (14.81%)
    3 / 52 (5.77%)
    7 / 80 (8.75%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bursitis infective
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CZP / CZP + PBO / CZP CZP / CZP + BKZ / CZP CZP / CZP / CZP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 27 (44.44%)
    23 / 52 (44.23%)
    26 / 80 (32.50%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    6 / 80 (7.50%)
         occurrences all number
    1
    1
    14
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 52 (3.85%)
    4 / 80 (5.00%)
         occurrences all number
    1
    2
    8
    Neutrophil count decreased
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 52 (5.77%)
    0 / 80 (0.00%)
         occurrences all number
    0
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 52 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    3
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 52 (0.00%)
    0 / 80 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 52 (5.77%)
    0 / 80 (0.00%)
         occurrences all number
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 52 (7.69%)
    3 / 80 (3.75%)
         occurrences all number
    0
    4
    4
    Rash
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 52 (1.92%)
    0 / 80 (0.00%)
         occurrences all number
    3
    2
    0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    4 / 27 (14.81%)
    3 / 52 (5.77%)
    5 / 80 (6.25%)
         occurrences all number
    6
    4
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 27 (11.11%)
    5 / 52 (9.62%)
    8 / 80 (10.00%)
         occurrences all number
    4
    5
    8
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 52 (7.69%)
    5 / 80 (6.25%)
         occurrences all number
    3
    5
    8
    Pharyngitis
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    3 / 80 (3.75%)
         occurrences all number
    1
    5
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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