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    Clinical Trial Results:
    A Multicenter Open-Label Extension Study for Subjects Who Participated in Study B0151003 (Andante II)

    Summary
    EudraCT number
    2011-000722-30
    Trial protocol
    GB   IE   GR   BE   DK   HU   IT   CZ   AT   SE  
    Global end of trial date
    01 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Feb 2017
    First version publication date
    15 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B0151005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    24 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the long term safety, tolerability, and immunogenicity of PF-04236921.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    7 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 6
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 63
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Ireland: 5
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    New Zealand: 4
    Worldwide total number of subjects
    191
    EEA total number of subjects
    80
    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)
    186
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 191 subjects were assigned to study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    PF-04236921
    Arm description
    All subjects entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The subjects were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if subjects experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-04236921
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Doses of PF-04236921 (50 mg [and 100 mg, if dose was escalated]) were administered SC at baseline and then every 8 weeks through Week 40.

    Number of subjects in period 1
    PF-04236921
    Started
    191
    Completed
    111
    Not completed
    80
         Protocol deviation
    1
         Lack of efficacy
    17
         Adverse event, non-fatal
    16
         Consent withdrawn by subject
    41
         Unspecified
    3
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-04236921
    Reporting group description
    All subjects entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The subjects were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if subjects experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.

    Reporting group values
    PF-04236921 Total
    Number of subjects
    191 191
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    186 186
        From 65-84 years
    5 5
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.1 ± 12.9 -
    Gender, Male/Female
    Units: Subjects
        FEMALE
    108 108
        MALE
    83 83

    End points

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    End points reporting groups
    Reporting group title
    PF-04236921
    Reporting group description
    All subjects entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The subjects were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if subjects experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.

    Primary: Number of Subjects with On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs

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    End point title
    Number of Subjects with On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs [1]
    End point description
    An AE was any untoward medical occurrence without regard to causality in a subject who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a subject on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 48
    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 statistical analysis was planned for this primary end point.
    End point values
    PF-04236921
    Number of subjects analysed
    191
    Units: subjects
        Subjects with AEs
    171
        Subjects with SAEs
    58
        Subjects discontinued due to AEs
    54
    No statistical analyses for this end point

    Primary: Percentage of Subjects Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

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    End point title
    Percentage of Subjects Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [2]
    End point description
    Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.
    End point type
    Primary
    End point timeframe
    At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
    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: No statistical analysis was planned for this primary end point.
    End point values
    PF-04236921
    Number of subjects analysed
    191
    Units: percentage of subjects
    number (not applicable)
        ADA positive
    0.52
        NAb positive
    0.52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 76
    Adverse event reporting additional description
    The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject might have experienced both a serious and non-serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    PF-04236921
    Reporting group description
    All subjects entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The subjects were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if subjects experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.

    Serious adverse events
    PF-04236921
    Total subjects affected by serious adverse events
         subjects affected / exposed
    79 / 191 (41.36%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oncocytoma
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion missed
         subjects affected / exposed [1]
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic fistula
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Procedural complication
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Ulcerative keratitis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal fistula
         subjects affected / exposed
    4 / 191 (2.09%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Anorectal disorder
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    41 / 191 (21.47%)
         occurrences causally related to treatment / all
    5 / 44
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fistula of small intestine
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    3 / 191 (1.57%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholangitis sclerosing
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    4 / 191 (2.09%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Bartholin's abscess
         subjects affected / exposed [2]
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Latent tuberculosis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mesenteric abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Percentage of gender specific events were calculated using the corresponding gender count as denominator.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Percentage of gender specific events were calculated using the corresponding gender count as denominator.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PF-04236921
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    150 / 191 (78.53%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 191 (6.81%)
         occurrences all number
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 191 (7.85%)
         occurrences all number
    16
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 191 (12.04%)
         occurrences all number
    32
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    14 / 191 (7.33%)
         occurrences all number
    17
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 191 (5.24%)
         occurrences all number
    10
    Insomnia
         subjects affected / exposed
    11 / 191 (5.76%)
         occurrences all number
    11
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    39 / 191 (20.42%)
         occurrences all number
    49
    Crohn's disease
         subjects affected / exposed
    45 / 191 (23.56%)
         occurrences all number
    57
    Nausea
         subjects affected / exposed
    21 / 191 (10.99%)
         occurrences all number
    29
    Diarrhoea
         subjects affected / exposed
    20 / 191 (10.47%)
         occurrences all number
    25
    Vomiting
         subjects affected / exposed
    22 / 191 (11.52%)
         occurrences all number
    26
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    14 / 191 (7.33%)
         occurrences all number
    16
    Rash
         subjects affected / exposed
    18 / 191 (9.42%)
         occurrences all number
    20
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 191 (6.28%)
         occurrences all number
    12
    Arthralgia
         subjects affected / exposed
    23 / 191 (12.04%)
         occurrences all number
    33
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    12 / 191 (6.28%)
         occurrences all number
    13
    Gastroenteritis
         subjects affected / exposed
    11 / 191 (5.76%)
         occurrences all number
    12
    Nasopharyngitis
         subjects affected / exposed
    31 / 191 (16.23%)
         occurrences all number
    40
    Urinary tract infection
         subjects affected / exposed
    16 / 191 (8.38%)
         occurrences all number
    18
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 191 (5.76%)
         occurrences all number
    13

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2011
    Harvey-Bradshaw Index category was changed from Health Outcomes Endpoint to Clinical Efficacy Assessment. The last injection site reaction assessment during the treatment period was moved from Week 44 to Week 48. An injection site reaction assessment was also added at the Early Withdrawal Visit.
    14 Jun 2011
    Specified that blood chemistry, hematology, urinalysis, autoantibodies, homocysteine, lipid profile, urine pregnancy test, and serum anti-PF-04236921 antibodies were only collected at Post Withdrawal Visits 2, 4, 6, and 8.
    03 Jul 2012
    In Pharmacokinetics/Pharmacodynamics (PK/PD) Section, updated to add flexibility in analyzing the Interleukin-6 (IL-6) samples and specified that the analysis might have been performed separately from the clinical study report, but the data listings would be included. Added exacerbation of Crohn’s Disease as an expected SAE and added additional information for medically important events into Protocol-Specified Serious and Non-Serious Adverse Events Section.
    27 Feb 2013
    Primarily addressed the changes in tuberculosis (TB) testing as a result of a special safety concern that occurred in the B0151006 study investigating PF-04236921 for the indication of systemic lupus erythematosus (SLE).

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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