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A Study of Japanese Rheumatoid Arthritis Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01253291
Collaborator
(none)
26
Enrollment
9
Locations
2
Arms
46
Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 30mg/120 mg LY2127399

Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.

Drug: LY2127399
Administered subcutaneously every 4 weeks for 48 weeks
Other Names:
  • tabalumab

    		•
    Experimental: 120 mg LY2127399

    Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.

    Drug: LY2127399
    Administered subcutaneously every 4 weeks for 48 weeks
    Other Names:
  • tabalumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline up to 72 weeks]

      Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.

    Secondary Outcome Measures

    1. Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Baseline and Weeks 12, 24, 36, 52, and 72]

      Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.

    2. Percent Change From Baseline in Rheumatoid Factor (RF) [Baseline and Weeks 12, 24, 36, 52, and 72]

      RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.

    3. Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA] [Baseline and Weeks 12, 24, 36, 52, and 72]

      IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.

    4. Percent Change From Baseline in CD20+ B-cell Count [Baseline and Weeks 12, 24, 36, 52, and 72]

      CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.

    5. Percent Change From Baseline in Peripheral B-cell Subsets [Baseline and Weeks 12, 24, 36, 52, and 72]

      Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.

    6. Percent Change From Baseline in C-Reactive Protein (CRP) [Baseline and Weeks 12, 24, 36, 52, and 72]

      CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.

    7. Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Baseline and Weeks 12, 24, 36, 52, and 72]

      ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • Have given written informed consent

    • Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation

    • Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)]

    Exclusion criteria

    • Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in

    • Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aichi Japan 460-0001
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chiba Japan 2892511
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fukui Japan 910-0067
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gunma Japan 370-0053
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hyogo Japan 673-1462
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ibaragi Japan 311-3516
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kanagawa Japan 252-0392
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miyagi Japan 982-0032
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tokyo Japan 152-8902

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST ), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01253291
    Other Study ID Numbers:
    • 13417
    • H9B-JE-BCDL
    First Posted:
    Dec 3, 2010
    Last Update Posted:
    Mar 1, 2019
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants who completed NCT01253226 [Study H9B-JE-BCDK (BCDK)] were enrolled into open-label study NCT01253291 [H9B-JE-BCDL (BCDL]).
    Arm/Group Title Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Arm/Group Description Participants who previously received placebo in Study BCDK were assigned to receive 120 milligrams (mg) of LY2127399 administered subcutaneously (SC) once every 4 weeks (Q4W) for 48 weeks. Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg of LY2127399 every 2 weeks (Q2W) in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Period Title: Overall Study
    STARTED 6 6 4 5 5
    Received Study Drug During BCDL 6 6 4 5 5
    COMPLETED 2 4 4 5 3
    NOT COMPLETED 4 2 0 0 2

    Baseline Characteristics

    Arm/Group Title Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W Total
    Arm/Group Description Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg of LY2127399 Q2W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Total of all reporting groups
    Overall Participants 6 6 4 5 5 26
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.7
    (17.4)
    66.5
    (5.7)
    47.8
    (16.9)
    53.8
    (14.1)
    55.8
    (8.6)
    56.4
    (13.5)
    Sex: Female, Male (Count of Participants)
    Female
    5
    83.3%
    6
    100%
    2
    50%
    3
    60%
    4
    80%
    20
    76.9%
    Male
    1
    16.7%
    0
    0%
    2
    50%
    2
    40%
    1
    20%
    6
    23.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    6
    100%
    6
    100%
    4
    100%
    5
    100%
    5
    100%
    26
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    6
    100%
    6
    100%
    4
    100%
    5
    100%
    5
    100%
    26
    100%
    Region of Enrollment (Count of Participants)
    Japan
    6
    100%
    6
    100%
    4
    100%
    5
    100%
    5
    100%
    26
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    Description Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
    Time Frame Baseline up to 72 weeks

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who received at least 1 dose of study drug during BCDL.
    Arm/Group Title Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Arm/Group Description Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 6 6 4 5 5
    SAEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Treatment Emergent Other Non-Serious AEs
    5
    83.3%
    4
    66.7%
    4
    100%
    3
    60%
    4
    80%
    2. Secondary Outcome
    Title Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
    Description Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with an anti-CCP antibody assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 9
    Anti-CCP Week 12
    19.9
    (54.4)
    Anti-CCP Week 24
    8.5
    (43.8)
    Anti-CCP Week 36
    -1.2
    (19.7)
    Anti-CCP Week 52
    17.4
    (50.7)
    Anti-CCP Week 72
    -4.4
    (31.7)
    3. Secondary Outcome
    Title Percent Change From Baseline in Rheumatoid Factor (RF)
    Description RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who had 1 or more RF assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 20
    RF Week 12
    -2.0
    (67.0)
    RF Week 24
    -9.7
    (47.8)
    RF Week 36
    -7.9
    (57.3)
    RF Week 52
    -2.3
    (63.7)
    RF Week 72
    25.3
    (98.0)
    4. Secondary Outcome
    Title Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
    Description IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with IgG, IgM or IgA assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 26
    IgG Week 12
    -4.4
    (13.0)
    IgG Week 24
    -3.8
    (11.0)
    IgG Week 36
    -5.1
    (12.1)
    IgG Week 52
    -5.1
    (14.2)
    IgG Week 72
    -2.0
    (14.5)
    IgM Week 12
    -7.7
    (11.6)
    IgM Week 24
    -9.3
    (12.4)
    IgM Week 36
    -11.6
    (12.5)
    IgM Week 52
    -12.4
    (15.8)
    IgM Week 72
    -9.0
    (24.9)
    IgA Week 12
    -5.0
    (12.9)
    IgA Week 24
    -6.0
    (14.5)
    IgA Week 36
    -7.2
    (15.4)
    IgA Week 52
    -5.8
    (13.2)
    IgA Week 72
    -2.6
    (20.1)
    5. Secondary Outcome
    Title Percent Change From Baseline in CD20+ B-cell Count
    Description CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with CD20+ B-Cell assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 26
    CD20+ B Week 12
    3.8
    (43.0)
    CD20+ B Week 24
    -17.3
    (31.9)
    CD20+ B Week 36
    -20.8
    (25.6)
    CD20+ B Week 52
    -32.0
    (18.7)
    CD20+ B Week 72
    -44.6
    (30.2)
    6. Secondary Outcome
    Title Percent Change From Baseline in Peripheral B-cell Subsets
    Description Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with Mature Naive B-Cells and Switched Memory B-Cells assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 25
    Mature Naive B-Cell Week 12
    -10.8
    (13.3)
    Mature Naive B-Cell Week 24
    -14.9
    (17.3)
    Mature Naive B-Cell Week 36
    -18.2
    (15.4)
    Mature Naive B-Cell Week 52
    -19.6
    (24.6)
    Mature Naive B-Cell Week 72
    7.6
    (18.5)
    Switched Memory B-Cell Week 12
    12.2
    (54.6)
    Switched Memory B-Cell Week 24
    28.7
    (76.7)
    Switched Memory B-Cell Week 36
    26.1
    (57.3)
    Switched Memory B-Cell Week 52
    50.9
    (106.8)
    Switched Memory B-Cell Week 72
    19.3
    (61.2)
    7. Secondary Outcome
    Title Percent Change From Baseline in C-Reactive Protein (CRP)
    Description CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with a CRP assessment at 1 or more of the specified timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 26
    CRP Week 12
    63.0
    (276.1)
    CRP Week 24
    15.4
    (106.9)
    CRP Week 36
    19.0
    (159.6)
    CRP Week 52
    -4.9
    (107.6)
    CRP Week 72
    7.1
    (110.4)
    8. Secondary Outcome
    Title Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
    Description ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.
    Time Frame Baseline and Weeks 12, 24, 36, 52, and 72

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants with an ESR assessment at 1 or more of the specific timepoints.
    Arm/Group Title 120 mg LY2127399 Q4W
    Arm/Group Description Participants who previously received placebo or 30 mg Q4W up to 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
    Measure Participants 26
    ESR Week 12
    -4.2
    (37.3)
    ESR Week 24
    -7.8
    (38.8)
    ESR Week 36
    -7.3
    (47.6)
    ESR Week 52
    -4.0
    (60.9)
    ESR Week 72
    -5.0
    (64.0)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Arm/Group Description Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks. Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
    All Cause Mortality
    Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/6 (16.7%) 0/6 (0%) 0/4 (0%) 0/5 (0%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo/LY2127399 120 mg Q4W LY2127399 30 mg Q4W/120 mg Q4W LY2127399 60 mg Q4W/120 mg Q4W LY2127399 120 mg Q4W/120 mg Q4W LY2127399 120 mg Q2W/120 mg Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/6 (83.3%) 4/6 (66.7%) 4/4 (100%) 3/5 (60%) 4/5 (80%)
    Ear and labyrinth disorders
    Deafness neurosensory 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Eye disorders
    Conjunctivitis 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Dry eye 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Keratoconjunctivitis sicca 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Gastrointestinal disorders
    Constipation 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Diarrhoea 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Gastritis 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Stomatitis 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    General disorders
    Injection site erythema 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Pyrexia 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/5 (0%) 0
    Hepatobiliary disorders
    Hepatic function abnormal 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/5 (0%) 0
    Infections and infestations
    Bronchitis 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/5 (0%) 0
    Cystitis 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Enteritis infectious 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Gastroenteritis 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/5 (0%) 0
    Herpes simplex 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Influenza 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 1/5 (20%) 1 0/5 (0%) 0
    Mycoplasma infection 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/5 (0%) 0
    Nasopharyngitis 1/6 (16.7%) 1 3/6 (50%) 3 1/4 (25%) 1 0/5 (0%) 0 3/5 (60%) 4
    Upper respiratory tract infection 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Injury, poisoning and procedural complications
    Contusion 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Investigations
    Weight decreased 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/5 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 2/5 (40%) 2 0/5 (0%) 0
    Intervertebral disc protrusion 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/5 (0%) 0
    Pain in extremity 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/5 (0%) 0
    Nervous system disorders
    Headache 1/6 (16.7%) 1 0/6 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/5 (0%) 0
    Reproductive system and breast disorders
    Metrorrhagia 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/5 (0%) 0
    Oropharyngeal pain 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 1/5 (20%) 1 0/5 (0%) 0
    Upper respiratory tract inflammation 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Skin and subcutaneous tissue disorders
    Blood blister 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Eczema 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Eczema asteatotic 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Eczema nummular 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Ingrowing nail 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Nail discolouration 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/5 (20%) 1
    Surgical and medical procedures
    Joint arthroplasty 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Transfusion 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/5 (0%) 0
    Vascular disorders
    Hypertension 0/6 (0%) 0 1/6 (16.7%) 1 1/4 (25%) 1 0/5 (0%) 0 0/5 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01253291
    Other Study ID Numbers:
    • 13417
    • H9B-JE-BCDL
    First Posted:
    Dec 3, 2010
    Last Update Posted:
    Mar 1, 2019
    Last Verified:
    Oct 1, 2018