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    Clinical Trial Results:
    Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

    Summary
    EudraCT number
    		 2013-002622-23
    Trial protocol
    		 NL   PT   BG   BE   DE   HU   ES   GR  
    Global end of trial date
    08 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2017
    First version publication date
    12 Nov 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1301.4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01955733
    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, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 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
    13 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To evaluate the long-term safety of BI 695500 in adult patients with moderate to severe active Rheumatoid Arthritis [RA] who have successfully completed treatment in Trial 1301.1. Secondary objective: To assess the long-term efficacy of BI 695500 in patients with moderately to severely active RA. These analyses will be displayed by the groups the patients were randomized in Trial 1301.1 as well as overall.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects 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
    02 Oct 2013
    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: 3
    Country: Number of subjects enrolled
    United States: 63
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Portugal: 3
    Worldwide total number of subjects
    97
    EEA total number of subjects
    23
    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)
    75
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 97 subjects were screened for eligibility to participate in this extension trial. 91 subjects met all inclusion and exclusion criteria and were assigned to receive treatment.

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they [the subjects] met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 695500
    Arm description
    		 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by Intravenous Infusion [IV]. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 695500
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by IV infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.

    Arm title
    		 Rituxan from 1301.1
    Arm description
    		 The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituxan from 1301.1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Arm title
    		 MabThera from 1301.1
    Arm description
    		 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MabThera from 1301.1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Number of subjects in period 1
    		BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Started
    33
    29
    29
    Completed
    32
    29
    29
    Not completed
    1
    0
    0
         Lost to follow-up
    1
    -
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 695500
    Arm description
    		 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by Intravenous Infusion [IV]. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 695500
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by IV infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.

    Arm title
    		 Rituxan from 1301.1
    Arm description
    		 The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituxan from 1301.1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Arm title
    		 MabThera from 1301.1
    Arm description
    		 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MabThera from 1301.1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The results presented in the outcome measures are based on period 2. Thus, period 2 is selected as the baseline period.
    Number of subjects in period 2 [2] [3]
    		BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Started
    30
    29
    29
    Completed
    18
    10
    8
    Not completed
    12
    19
    21
         Consent withdrawn by subject
    1
    3
    2
         Other not defined above
    -
    2
    2
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    -
         Study terminated by sponsor
    8
    14
    15
         Lost to follow-up
    2
    -
    1
    Notes
    [2] - 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 of the trial medications.
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 2 subjects from 1301.1 safety run-in who also received treatment in 1301.4. Thus, the number of subjects in period 2 is 88.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 2
    Reporting group description
    		 -

    Reporting group values
    		 Period 2 Total
    Number of subjects
    		 88
    Age categorical
    Units: Subjects
    Age Continuous
    Safety Randomized Analysis Set [SAFRD]: All subjects randomized in 1301.1 [excluding open-label safety run-in subjects of trial 1301.1] who receive at least one dose of trial medication and subjects will be classified according to treatment received in trial 1301.1. 2 subjects from 1301.1 safety run-in also received treatment in 1301.4, thus 88.
    Units: years
        arithmetic mean (standard deviation)
    		 55.9 ( 10.38 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 67 67
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    BI 695500
    Reporting group description
    		 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by Intravenous Infusion [IV]. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.

    Reporting group title
    Rituxan from 1301.1
    Reporting group description
    		 The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Reporting group title
    MabThera from 1301.1
    Reporting group description
    		 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
    Reporting group title
    BI 695500
    Reporting group description
    		 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by Intravenous Infusion [IV]. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.

    Reporting group title
    Rituxan from 1301.1
    Reporting group description
    		 The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Reporting group title
    MabThera from 1301.1
    Reporting group description
    		 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Primary: The percentage of patients with drug related adverse events during the treatment phase

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    End point title
    		 The percentage of patients with drug related adverse events during the treatment phase [1]
    End point description
    This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events [TEAEs] were defined as AEs that started or worsened in severity on or after the first dose of trial medication in this extension study [1301.4] and prior to the last date of trial medication + 180 days [inclusive]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
    End point type
    Primary
    End point timeframe
    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: Statistical analysis evaluating this endpoint was purely for exploratory purposes.
    End point values
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Number of subjects analysed
    30 [2]
    29 [3]
    29 [4]
    Units: Percentage of patients
        number (not applicable)
    16.7
    6.9
    3.4
    Notes
    [2] - SAFRD.
    [3] - SAFRD.
    [4] - SAFRD.
    No statistical analyses for this end point

    Secondary: The change from baseline in trial 1301.1 in DAS28 [Disease Activity Score 28][Erythrocyte Sedimentation Rate [ESR] at Week 48 of Trial 1301.4

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    End point title
    		 The change from baseline in trial 1301.1 in DAS28 [Disease Activity Score 28][Erythrocyte Sedimentation Rate [ESR] at Week 48 of Trial 1301.4
    End point description
    This outcome measure presents the change from baseline in trial 1301.1 in DAS28 ESR at Week 48 of Trial 1301.4. Assigned Set [ASD]: All subjects in the Enrolled Set [ENR set][All subjects who provide informed consent for this trial] who were assigned to trial medication in 1301.4 and who were randomized to trial medication in 1301.1 [initial randomization at Day 1] or entered in open-label safety run-in. Abbreviation used: CRP: C-Reactive Protein. ACR20: American College of Rheumatology 20% response criteria. Full Analysis Set [FAS]: Subjects from the ASD by excluding subjects from the open-label safety run-in in trial 1301.1, who received at least one dose of trial medication, and had data recorded for at least one DAS28 [ESR or CRP] or ACR20 during the trial.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Number of subjects analysed
    19 [5]
    19 [6]
    17 [7]
    Units: mm/h
        number (not applicable)
    -2.0
    -2.0
    -1.6
    Notes
    [5] - FAS.
    [6] - FAS.
    [7] - FAS.
    No statistical analyses for this end point

    Secondary: The percentage of patients meeting the ACR20 [based on improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4

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    End point title
    		 The percentage of patients meeting the ACR20 [based on improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4
    End point description
    This outcome measure presents the percentage of patients meeting the 20% ACR20 response criteria [based on improvement since baseline in trial 1301.1] at Week 48 of Trial 1301.4.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Number of subjects analysed
    30 [8]
    26 [9]
    28 [10]
    Units: Percentage of patients
        number (not applicable)
    10.0
    7.7
    7.1
    Notes
    [8] - FAS.
    [9] - FAS.
    [10] - FAS.
    No statistical analyses for this end point

    Secondary: The percentage of patients who meet the ACR/European League Against Rheumatism [EULAR] definition of remission [based on improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4

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    End point title
    		 The percentage of patients who meet the ACR/European League Against Rheumatism [EULAR] definition of remission [based on improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4
    End point description
    This outcome measure presents the percentage of patients who meet the ACR/EULAR definition of remission [based on improvement since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Number of subjects analysed
    30 [11]
    26 [12]
    28 [13]
    Units: Percentage of patients
        number (not applicable)
    0.0
    0.0
    0.0
    Notes
    [11] - FAS.
    [12] - FAS.
    [13] - FAS.
    No statistical analyses for this end point

    Secondary: The percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4

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    End point title
    		 The percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4
    End point description
    This outcome measure presents percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Number of subjects analysed
    30 [14]
    26 [15]
    28 [16]
    Units: Percentage of patients
    number (not applicable)
        Good response
    0.0
    0.0
    0.0
        Moderate response
    3.3
    7.7
    0.0
        No response
    13.3
    15.4
    14.3
        Missing
    43.3
    15.4
    14.3
    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
    Enter time frame here
    Adverse event reporting additional description
    AEs are presented for the Safety Randomised Analysis Set [SAF] which consisted of all randomised subjects who received at least one dose of trial medication in this extension study [1301.4].
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    BI 695500
    Reporting group description
    		 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by Intravenous Infusion [IV]. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.

    Reporting group title
    Rituxan from 1301.1
    Reporting group description
    		 The Rituxan from 1301.1 [ClinicalTrials.gov identifier: NCT01682512] recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Reporting group title
    MabThera from 1301.1
    Reporting group description
    		 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.

    Serious adverse events
    		 BI 695500 Rituxan from 1301.1 MabThera from 1301.1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (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
    Nervous system disorders
    Cerebral microangiopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (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
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         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
    Pulmonary embolism
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (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
    Cellulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 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 695500 Rituxan from 1301.1 MabThera from 1301.1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 30 (23.33%)
    8 / 29 (27.59%)
    9 / 29 (31.03%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    1
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 29 (6.90%)
    4 / 29 (13.79%)
         occurrences all number
    3
    2
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    1
    Insomnia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0

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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.
    Further development of BI 695500 has been stopped and the program was therefore prematurely discontinued on 3SEP2015. The decision was made by the Sponsor based on a strategic review of company’s product portfolio and not due to any safety concern.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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