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    Clinical Trial Results:
    Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis: an open-label extension trial for patients who have completed Trial 1297.2 and are eligible for long-term treatment with adalimumab.

    Summary
    EudraCT number
    		 2015-002634-41
    Trial protocol
    		 HU   ES   DE   PL   BG  
    Global end of trial date
    01 Nov 2017

    Results information
    Results version number
    		 v1
    This version publication date
    15 Nov 2018
    First version publication date
    15 Nov 2018
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    1297.3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02640612
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.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
    21 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial was to provide long-term safety, efficacy, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via pre-filled syringe in patients with rheumatoid arthritis (RA) who have completed Trial 1297.2 (NCT02137226).
    Protection of trial subjects
    Only patients that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All patients were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all patients was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2016
    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
    Spain: 8
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Ukraine: 94
    Country: Number of subjects enrolled
    United States: 66
    Country: Number of subjects enrolled
    Bulgaria: 52
    Country: Number of subjects enrolled
    Chile: 27
    Country: Number of subjects enrolled
    Estonia: 8
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Malaysia: 2
    Country: Number of subjects enrolled
    Poland: 139
    Country: Number of subjects enrolled
    Russian Federation: 22
    Country: Number of subjects enrolled
    Serbia: 29
    Worldwide total number of subjects
    479
    EEA total number of subjects
    232
    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)
    392
    From 65 to 84 years
    87
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Open-label extension trial in adult patients with moderate to severely active rheumatoid arthritis (RA) who completed Trial NCT02137226 (1297.2), wished to participate in this extension trial and per Investigator’s assessment could benefit from continuing to receive BI 695501 were included in this trial. Out of 479 screened patients 430 entered.

    Pre-assignment
    Screening details
    		 All patients were screened for eligibility to participate in the trial. The trial consisted of a Screening visit 14 days prior to Day 1, a 48-week treatment period and a 10-week safety follow up (SFU) period. The screening visit was the Week 48 visit in Trial 1297.2.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding of BI 695501 was performed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 695501 to BI 695501
    Arm description
    		 Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 695501
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg/0.8 mL every 2 weeks from Day 1 to week 48.

    Arm title
    		 Humira® to Humira®
    Arm description
    		 Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Humira®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg/0.8 mL every 2 weeks from Day 1 to Week 48.

    Arm title
    		 Humira® to BI 695501
    Arm description
    		 Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    BI 695501
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg/0.8 mL every 2 weeks from Day 1 to Week 48.

    Investigational medicinal product name
    Humira®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg/0.8 mL every 2 weeks from Day 1 to Week 48.

    Number of subjects in period 1 [1]
    		BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Started
    225
    103
    102
    Completed
    203
    89
    96
    Not completed
    22
    14
    6
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    10
    3
    3
         Adverse event, non-fatal
    6
    7
    2
         Lost to follow-up
    4
    1
    1
         Lack of efficacy
    1
    1
    -
         Protocol deviation
    -
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BI 695501 to BI 695501
    Reporting group description
    		 Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to Humira®
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to BI 695501
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Reporting group values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501 Total
    Number of subjects
    		 225 103 102 430
    Age categorical
    Units: Subjects
    Age Continuous
    Age of all patients included in the trial. Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
    Units: years
        arithmetic mean (standard deviation)
    		 53.8 ( 11.87 ) 51.7 ( 11.21 ) 54.6 ( 9.90 ) -
    Sex: Female, Male
    Gender distribution of all patients included in the trial. Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
    Units: Subjects
        Female
    		 188 88 84 360
        Male
    		 37 15 18 70
    Race (NIH/OMB)
    Race of all patients included in the trial. Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 7 2 0 9
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 3 0 2 5
        White
    		 215 100 100 415
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 1 0 1
    Ethnicity (NIH/OMB)
    Ethnicity of all patients included in the trial. Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
    Units: Subjects
        Hispanic or Latino
    		 23 8 10 41
        Not Hispanic or Latino
    		 199 94 92 385
        Unknown or Not Reported
    		 3 1 0 4

    End points

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    End points reporting groups
    Reporting group title
    BI 695501 to BI 695501
    Reporting group description
    		 Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to Humira®
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to BI 695501
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Primary: Percentage of patients with drug-related Adverse Events (AEs) during the treatment phase

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    End point title
    		 Percentage of patients with drug-related Adverse Events (AEs) during the treatment phase [1]
    End point description
    The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked “yes” according to the Investigator. Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
    End point type
    Primary
    End point timeframe
    From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.
    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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    End point values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Number of subjects analysed
    225 [2]
    103 [3]
    102 [4]
    Units: Percentage of patients (%)
        number (not applicable)
    21.3
    20.4
    17.6
    Notes
    [2] - SAF
    [3] - SAF
    [4] - SAF
    No statistical analyses for this end point

    Secondary: Change from Baseline in Disease Activity Score in 28 joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at week 48

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    End point title
    		 Change from Baseline in Disease Activity Score in 28 joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at week 48
    End point description
    The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component ofthe DAS (patient’s global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of1297.2.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48.
    End point values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Number of subjects analysed
    225 [5]
    103 [6]
    101 [7]
    Units: Unit on scale
        arithmetic mean (standard deviation)
    -3.01 ( 1.385 )
    -2.91 ( 1.323 )
    -2.98 ( 1.218 )
    Notes
    [5] - FAS
    [6] - FAS
    [7] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of patients meeting American College of Rheumatology (ACR) 20% response criteria at Week 48

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    End point title
    		 Percentage of patients meeting American College of Rheumatology (ACR) 20% response criteria at Week 48
    End point description
    The percentage of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient’s assessment of pain, Patient’s global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician’s global assessment of disease activity, Patient’s assessment of physical function, as measured by the Health Assessment Questionnaire – Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).
    End point type
    Secondary
    End point timeframe
    Week 48.
    End point values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Number of subjects analysed
    225 [8]
    103 [9]
    101 [10]
    Units: Percentage of patients (%)
        number (not applicable)
    76.9
    76.7
    73.3
    Notes
    [8] - FAS (NRI)
    [9] - FAS (NRI)
    [10] - FAS (NRI)
    No statistical analyses for this end point

    Secondary: Percentage of patients who meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) definition of remission at Week 48

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    End point title
    		 Percentage of patients who meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) definition of remission at Week 48
    End point description
    The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following: • Tender joint count (TJC) ≤ 1 • Swollen joint count (SJC) ≤ 1 • C-reactive protein (CRP) ≤ 1 milligram/decilitre (mg/dL) • Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale). For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission.
    End point type
    Secondary
    End point timeframe
    Week 48.
    End point values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Number of subjects analysed
    225 [11]
    103 [12]
    101 [13]
    Units: Percentage of patients (%)
        number (not applicable)
    8.4
    9.7
    6.9
    Notes
    [11] - FAS
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) at Week 48

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    End point title
    		 Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) at Week 48
    End point description
    Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 (w48) for assessment of this outcome measure. No response: If improvement in DAS28 (ESR) at w48 <=0.6, or if DAS28(ESR) at w48 >5.1 and improvement is in range >0.6 to <1.2. Moderate response: If DAS28(ESR) at w48 <=5.1 and improvement is in range >0.6 to <1.2, or, DAS28(ESR) at w48 >3.2 and improvement is in range >=1.2. Good response: If DAS28(ESR) at w48 <=3.2 and improvement >=1.2.
    End point type
    Secondary
    End point timeframe
    Week 48.
    End point values
    		 BI 695501 to BI 695501 Humira® to Humira® Humira® to BI 695501
    Number of subjects analysed
    225 [14]
    103 [15]
    101 [16]
    Units: Percentage of patients (%)
    number (not applicable)
        Good Response|
    37.8
    37.9
    41.6
        Moderate Response|
    49.8
    54.4
    51.5
        No Response|
    9.3
    5.8
    3.0
    Notes
    [14] - FAS
    [15] - FAS
    [16] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.
    Adverse event reporting additional description
    An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. SAF was used for AE assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    BI 695501 to BI 695501
    Reporting group description
    		 Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to BI 695501
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Reporting group title
    Humira® to Humira®
    Reporting group description
    		 Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.

    Serious adverse events
    		 BI 695501 to BI 695501 Humira® to BI 695501 Humira® to Humira®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 225 (6.22%)
    4 / 102 (3.92%)
    8 / 103 (7.77%)
         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)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Basal cell carcinoma
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign soft tissue neoplasm
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (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
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Abdominal pain upper
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Small intestinal obstruction
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Umbilical hernia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Uterine polyp
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (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
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Interstitial lung disease
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         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
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Otitis media
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Pneumonia
         subjects affected / exposed
    4 / 225 (1.78%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Sepsis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 102 (0.00%)
    0 / 103 (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
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         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
    		 BI 695501 to BI 695501 Humira® to BI 695501 Humira® to Humira®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 225 (4.00%)
    2 / 102 (1.96%)
    6 / 103 (5.83%)
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 225 (4.00%)
    2 / 102 (1.96%)
    6 / 103 (5.83%)
         occurrences all number
    10
    3
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2016
    The details of the Trial Clinical Monitor were updated. The permitted visit window for the Screening visit was changed on the trial flowchart from ± 1 day to ± 3 days to align with Trial 1297.2. Footnotes in the trial flow chart were updated to specify that Visual analogue scale (VAS) assessments and completion of the Health Assessment Questionnaire – Disability Index (HAQ-DI) and 36-item Short Form Health Survey version 2 (SF-36 v2) questionnaires must be done prior to any visit procedures to avoid bias and that questionnaires completed for Trial 1297.2 would be used as baseline for Trial 1297.3. Footnotes in the trial flow chart were updated to specify that 2 consecutive Electrocardiogram (ECG) recordings needed to be taken. The requirement for patients with major protocol deviations in Trial 1297.2 was removed. Patients with major protocol deviations related to safety would still be excluded from Trial 1297.3 based on other specific exclusion criteria. Text was corrected regarding training of the independent joint assessor and for storage of Pharmacokinetic (PK) samples was revised in accordance with local regulation. The wording of information for storage of Anti-drug antibody (ADA) samples was revised as for the PK samples. Patient incidence was corrected from 100 patient-years to 1000 patient-years. References to off-treatment efficacy assessments were removed, as no off-treatment efficacy data was to be collected.

    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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