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    Clinical Trial Results:
    Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.

    Summary
    EudraCT number
    		 2012-001618-40
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    19 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2018
    First version publication date
    09 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H9B-MC-BCEF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01676701
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14598
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    19 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study was to include a 12-week treatment period, optional 40-week safety extension, and post-treatment follow-up (at least 24 weeks). At the time of early study termination, all participants who had received tabalumab discontinued dosing and then completed the post-treatment follow-up period. No one entered the 40-week safety extension period. This study has been terminated not based on safety concerns, but due to insufficient efficacy.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    29
    EEA total number of subjects
    3
    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)
    22
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered.

    Pre-assignment
    Screening details
    		 No text entered.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tabalumab Auto-Injector
    Arm description
    		 Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tabalumab Auto-Injector
    Investigational medicinal product code
    Other name
    LY2127399
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.

    Arm title
    		 Tabalumab Prefilled Syringe
    Arm description
    		 Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tabalumab Prefilled Syringe
    Investigational medicinal product code
    Other name
    LY2127399
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.

    Number of subjects in period 1 [1]
    		Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Started
    4
    4
    Received at Least 1 Dose of Study Drug
    4
    4
    Completed Post-Treatment Follow-Up
    4
    4
    Completed
    0
    0
    Not completed
    4
    4
         Sponsor Decision
    3
    4
         Protocol deviation
    1
    -
    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: The number of participants entered trial are 29 and the number of participants entered treatment are 4.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tabalumab Auto-Injector
    Reporting group description
    		 Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).

    Reporting group title
    Tabalumab Prefilled Syringe
    Reporting group description
    		 Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

    Reporting group values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe Total
    Number of subjects
    		 4 4 8
    Age categorical
    Units: Subjects
        43.3 to 65.4 years
    		 4 4 8
    Gender categorical
    Units: Subjects
        Female
    		 3 3 6
        Male
    		 1 1 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 4 3 7
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 4 3 7
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 4 4 8

    End points

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    End points reporting groups
    Reporting group title
    Tabalumab Auto-Injector
    Reporting group description
    		 Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).

    Reporting group title
    Tabalumab Prefilled Syringe
    Reporting group description
    		 Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

    Primary: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose

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    End point title
    		 Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose [1]
    End point description
    No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Primary
    End point timeframe
    Days 4, 7, 9, 11, and 14 after loading dose administered
    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 end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: insufficient sample size
    Notes
    [2] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [3] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]

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    End point title
    		 PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Days 4, 7, 9, 11, and 14 after loading dose administered
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: insufficient sample size.
    Notes
    [4] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [5] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set

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    End point title
    		 Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: insufficient sample size.
    Notes
    [6] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [7] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ACR Response

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    End point title
    		 Percentage of Participants Achieving ACR Response
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: insufficient sample size
    Notes
    [8] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [9] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index

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    End point title
    		 Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: insufficient sample size
    Notes
    [10] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [11] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level

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    End point title
    		 Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: insufficient sample size
    Notes
    [12] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [13] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)

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    End point title
    		 Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: insufficient sample size
    Notes
    [14] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [15] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Number of Participants Developing Anti-Tabalumab Antibodies

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    End point title
    		 Number of Participants Developing Anti-Tabalumab Antibodies
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: insufficient sample size
    Notes
    [16] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [17] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Number of Operation Failures

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    End point title
    		 Number of Operation Failures
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: insufficient sample size
    Notes
    [18] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [19] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Secondary: Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)

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    End point title
    		 Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)
    End point description
    No end point data analyzed due to the termination of the trial and an insufficient sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4 and 8
    End point values
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: insufficient sample size
    Notes
    [20] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    [21] - No end point data analyzed due to the termination of the trial and an insufficient sample size.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H9B-MC-BCEF
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Tabalumab Auto-Injector
    Reporting group description
    		 -

    Reporting group title
    Tabalumab Prefilled Syringe
    Reporting group description
    		 -

    Serious adverse events
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tabalumab Auto-Injector Tabalumab Prefilled Syringe
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    Infections and infestations
    Gastric Infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to early termination of the trial, no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.
    For support, Contact us.
    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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