A Rheumatoid Arthritis Study in Participants | NCT01202760 | Trialant
NCT01202760
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 25, 2018Actual
Enrollment
1,004Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
LY2127399
Placebo
Countries
United States
Argentina
Australia
Bulgaria
Colombia
Croatia
Hungary
India
Japan
Lithuania
Malaysia
Mexico
New Zealand
Poland
Romania
Russia
Slovakia
South Africa
South Korea
Sri Lanka
Taiwan
Ukraine
Protocol Section
Identification Module
NCT ID
NCT01202760
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12978
Secondary IDs
ID
Type
Description
Link
H9B-MC-BCDO
Other Identifier
Eli Lilly and Company
CTRI/2011/07/001867
Registry Identifier
Clinical Trials Registry India
Brief Title
A Rheumatoid Arthritis Study in Participants
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
Acronym
FLEX O
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2011
Primary Completion Date
Dec 2012Actual
Completion Date
Jul 2013Actual
First Submitted Date
Sep 14, 2010
First Submission Date that Met QC Criteria
Sep 14, 2010
First Posted Date
Sep 16, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2018
Results First Submitted that Met QC Criteria
Mar 24, 2018
Results First Posted Date
Apr 25, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 30, 2013
Certification/Extension First Submitted that Passed QC Review
Apr 30, 2013
Certification/Extension First Posted Date
May 8, 2013Estimated
Last Update Submitted Date
Mar 24, 2018
Last Update Posted Date
Apr 25, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.
This study is comprised of 2 periods:
Period 1 - 24-week blinded treatment
Period 2 - 48-week post-treatment follow-up
Detailed Description
In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with <20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,004Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
120 mg LY2127399
Experimental
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Drug: LY2127399
Drug: Placebo
90 mg LY2127399
Experimental
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Drug: LY2127399
Placebo
Placebo Comparator
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Drug: LY2127399
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2127399
Drug
120 mg LY2127399
90 mg LY2127399
Placebo
Tabalumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >=20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
Up to 24 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had >=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and >=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)*100. ACR70 Responder: had >=70% improvement from baseline in both TJ and SJ counts and >=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
Women must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria:
Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
Steroid injection or intravenous (IV) infusion in the last 6 weeks
Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
Use of biologic DMARD concurrently or recently
History of a serious reaction to other biological DMARDs
Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study
Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
Received a live vaccine within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
Hepatitis or human immunodeficiency virus (HIV)
A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
Symptoms of herpes zoster or herpes simplex within the last month
Active or latent tuberculosis (TB)
Current symptoms of a serious disorder or illness
Use of an investigational drug within the last month
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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 Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
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.
Birmingham
Alabama
35216
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Peru
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Placebo
Drug
120 mg LY2127399
Placebo
Up to 24 weeks
Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If >=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.
Up to 24 weeks
Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)
Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)
Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)
Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)
Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Time to American College of Rheumatology 20% (ACR20) Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
Baseline through 24 weeks
Probability of an ACR20 Response by 24 Weeks
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
Baseline through 24 weeks
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response
EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP <=5.1 and DAS28-CRP change <-0.6; or DAS28-CRP >5.1 and DAS28-CRP change <-1.2. EULAR28 responder index is defined as good response: DAS28-CRP <=3.2 and DAS28-CRP change <-1.2; moderate response: DAS28-CRP change <-1.2 except cases defined in good response; or DAS28-CRP <=5.1 and DAS28-CRP change <-0.6 and >-1.2. EULAR Remission is defined as a DAS28-CRP score of <2.6.
Up to 24 weeks
Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical health [PCS]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint
CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
Baseline, up to 24 weeks
Population Pharmacokinetics (PK)
Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.
Baseline through 24 weeks
Percentage of Participants Developing Anti-LY2127399 Antibodies
LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Baseline through 24 weeks
United States
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.
Paradise Valley
Arizona
85253
United States
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.
Peoria
Arizona
85381
United States
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.
Phoenix
Arizona
85018
United States
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.
Scottsdale
Arizona
85251
United States
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Tucson
Arizona
85704
United States
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Hot Springs
Arkansas
71913
United States
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Little Rock
Arkansas
72205
United States
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San Diego
California
92103
United States
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.
Torrance
California
90505
United States
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.
Tustin
California
92780
United States
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Whittier
California
90606
United States
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Wildomar
California
92595
United States
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Colorado Springs
Colorado
80910
United States
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Lewes
Delaware
19958
United States
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Aventura
Florida
33180
United States
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DeBary
Florida
32713
United States
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Palm Harbor
Florida
34684
United States
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Pinellas Park
Florida
33781
United States
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St. Petersburg
Florida
33716
United States
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Tamarac
Florida
33321
United States
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Venice
Florida
34292
United States
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Zephyrhills
Florida
33542
United States
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Decatur
Georgia
30033
United States
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Gainesville
Georgia
30501
United States
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Lawrenceville
Georgia
30045
United States
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Marietta
Georgia
30060
United States
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Savannah
Georgia
31405
United States
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Eagle
Idaho
83616
United States
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Morton Grove
Illinois
60053
United States
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Rockford
Illinois
61103
United States
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Indianapolis
Indiana
46227
United States
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Wichita
Kansas
67208
United States
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Cumberland
Maryland
21502
United States
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Hyannis
Massachusetts
02601
United States
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Worcester
Massachusetts
01605
United States
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Bingham Farms
Michigan
48025
United States
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Saint Clair Shores
Michigan
48081
United States
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Flowood
Mississippi
39232
United States
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Jackson
Mississippi
39202
United States
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St Louis
Missouri
63131
United States
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Lincoln
Nebraska
68516
United States
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Omaha
Nebraska
68134
United States
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Las Vegas
Nevada
89123
United States
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Albuquerque
New Mexico
87108
United States
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Brooklyn
New York
11201
United States
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Roslyn
New York
11576
United States
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Syracuse
New York
13210
United States
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Charlotte
North Carolina
28210
United States
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Hickory
North Carolina
28601
United States
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Raleigh
North Carolina
27609
United States
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Cincinnati
Ohio
45242
United States
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Oklahoma City
Oklahoma
73103
United States
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Tulsa
Oklahoma
74135
United States
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Bend
Oregon
97701
United States
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Bethlehem
Pennsylvania
18017
United States
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Limerick
Pennsylvania
19468
United States
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Philadelphia
Pennsylvania
19152
United States
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Pottstown
Pennsylvania
19464
United States
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Columbia
South Carolina
29204
United States
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Greenville
South Carolina
29601
United States
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Greer
South Carolina
29650
United States
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Myrtle Beach
South Carolina
29572
United States
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North Charleston
South Carolina
29406
United States
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Knoxville
Tennessee
37909
United States
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Memphis
Tennessee
38119
United States
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Nashville
Tennessee
37205
United States
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Austin
Texas
78731
United States
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Dallas
Texas
75231
United States
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Lake Jackson
Texas
77566
United States
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Lubbock
Texas
79424
United States
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Mesquite
Texas
75150
United States
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Nassau Bay
Texas
77058
United States
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North Richland Hills
Texas
76180
United States
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San Antonio
Texas
78217
United States
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Sugar Land
Texas
77478
United States
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Spokane
Washington
99204
United States
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Buenos Aires
C1280AEB
Argentina
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Córdoba
X5016KEH
Argentina
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Mar del Plata
B7600FZN
Argentina
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Rosario
2000
Argentina
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San Juan
5400
Argentina
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San Miguel de Tucumán
4000
Argentina
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Kogarah
New South Wales
04266-010
Australia
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Herston
Queensland
4029
Australia
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Malvern East
3145
Australia
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Burgas
8000
Bulgaria
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Pleven
5800
Bulgaria
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Plovdiv
4003
Bulgaria
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Rousse
7002
Bulgaria
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Sevlievo
5400
Bulgaria
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Sofia
1784
Bulgaria
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Varna
9000
Bulgaria
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Bogotá
Colombia
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Medellín
Colombia
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Opatija
51410
Croatia
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Rijeka
HR-51000
Croatia
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Split
21000
Croatia
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Budapest
1036
Hungary
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Debrecen
4032
Hungary
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Kiskunhalas
6400
Hungary
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Nyíregyháza
4400
Hungary
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Sátoraljaújhely
3980
Hungary
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Szikszó
3800
Hungary
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Veszprém
8200
Hungary
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Ahmedabad
3800015
India
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Bangalore
5600092
India
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Chennai
600100
India
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Hyderabaad
500033
India
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Jaipur
302023
India
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Mysore
570023
India
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Nellore
524003
India
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New Delhi
110 076
India
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Secunderabad
500 003
India
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Surat
560092
India
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Aichi
460-0001
Japan
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Fukuoka
820-8505
Japan
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Gunma
370-0053
Japan
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Hokkaido
063-0811
Japan
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Hyōgo
650-0017
Japan
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Ibaraki
316-0035
Japan
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Kanagawa
252-0392
Japan
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Kumamoto
861-8520
Japan
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Mie
514-1101
Japan
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Miyagi
982-0032
Japan
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Nagano
390-8601
Japan
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Nagasaki
857-1195
Japan
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Nara
634-0007
Japan
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Ohita
874-0011
Japan
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Okayama
712-8044
Japan
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Osaka
586-8521
Japan
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Saga
843-0393
Japan
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Saitama
337-0012
Japan
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Sapporo
060-8648
Japan
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Shizuoka
420-8623
Japan
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Tokyo
185-0012
Japan
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Tomakomai
053-8567
Japan
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Alytus
62114
Lithuania
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Kaunas
49475
Lithuania
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Klaipedos
92288
Lithuania
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Šiauliai
73231
Lithuania
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Vilnius
LT-08661
Lithuania
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Batu Caves
68100
Malaysia
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Kuantan Pahang
25100
Malaysia
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Perak
30990
Malaysia
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Sarawak
93586
Malaysia
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Aguascalientes
20203
Mexico
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Chihuahua City
31000
Mexico
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Guadalajara
44690
Mexico
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Mexicali
21100
Mexico
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Mexico City
06100
Mexico
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Monterrey
64000
Mexico
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Morelia
58070
Mexico
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Querétaro
76000
Mexico
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San Luis Potosí City
78200
Mexico
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Tijuana
22010
Mexico
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Tlalpan
14080
Mexico
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Hamilton
3204
New Zealand
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Rotorua
3010
New Zealand
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Tauranga
3140
New Zealand
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Timaru
New Zealand
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Bydgoszcz
85-168
Poland
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Elblag
82-300
Poland
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Gdynia
81-384
Poland
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Krakow
30-510
Poland
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Lublin
20-607
Poland
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Torun
87-100
Poland
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Warsaw
01-192
Poland
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Brasov
500365
Romania
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Cluj-Napoca
400130
Romania
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Iași
700656
Romania
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Ploieşti
100337
Romania
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Barnaul
656038
Russia
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Kemerovo
650066
Russia
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Kursk
305007
Russia
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Moscow
111539
Russia
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Nizhny Novgorod
603005
Russia
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Novosibirsk
630047
Russia
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Ryazan
390026
Russia
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Saint Petersburg
197022
Russia
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Stavropol
355017
Russia
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Bratislava
84231
Slovakia
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Piešťany
921 12
Slovakia
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Benoni
1500
South Africa
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Bloemfontein
9301
South Africa
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Breyten
2330
South Africa
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Cape Town
7925
South Africa
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Durban
4092
South Africa
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Limpopo
0380
South Africa
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Pretoria
0184
South Africa
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Somerset West
7130
South Africa
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Stellenbosch
7600
South Africa
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Westville
3630
South Africa
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Busan
602-715
South Korea
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Daegu
700-721
South Korea
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Seoul
134-727
South Korea
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Colombo
Sri Lanka
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Galle
Sri Lanka
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Kalubowila
Sri Lanka
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Nugegoda
Sri Lanka
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Keelong
333
Taiwan
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Kuei Shan Hsiang
33305
Taiwan
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Taichung
407
Taiwan
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Taipei
112
Taiwan
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Dnipropetrovsk
49008
Ukraine
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Donetsk
83045
Ukraine
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Kharkiv
61178
Ukraine
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Kiev
04114
Ukraine
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Kyiv
03151
Ukraine
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Odesa
65026
Ukraine
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Poltava
36038
Ukraine
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Simferopol
95017
Ukraine
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Vinnytsia
21018
Ukraine
FG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
FG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
FG000379 subjects
FG001374 subjects
FG002251 subjects
Received at Least One Dose of Study Drug
FG000379 subjects
FG001371 subjects
FG002250 subjects
COMPLETED
FG000332 subjects
FG001322 subjects
FG002216 subjects
NOT COMPLETED
FG00047 subjects
FG00152 subjects
FG00235 subjects
Type
Comment
Reasons
Entry Criteria Not Met
FG0000 subjects
FG0013 subjects
FG0021 subjects
Adverse Event
FG00011 subjects
FG0019 subjects
FG00210 subjects
Death
FG0002 subjects
FG0011 subjects
FG0020 subjects
Lack of Efficacy
FG0006 subjects
FG0018 subjects
FG0027 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
Parent / Caregiver Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG00017 subjects
FG00118 subjects
FG00214 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
Protocol Violation
FG0007 subjects
FG0015 subjects
FG0022 subjects
Sponsor Decision
FG0004 subjects
FG0014 subjects
FG0020 subjects
All randomized participants, including participants who did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
BG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
BG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000379
BG001374
BG002251
BG0031004
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.4± 11.2
BG00150.6± 12.2
BG00251.0± 12.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000293
BG001295
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00038
BG00147
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00013
BG00121
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG000126
BG001125
BG002
Tender Joint Count (68 Count)
Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.
Mean
Standard Deviation
joint count
Title
Denominators
Categories
Title
Measurements
BG00022.8± 15.5
BG001
Swollen Joint Count (66 Count)
Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
Mean
Standard Deviation
joint count
Title
Denominators
Categories
Title
Measurements
BG00014.8± 11.6
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >=20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable ACR20 data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.
Posted
Number
percentage of participants
Up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000320
OG001316
OG002213
Title
Denominators
Categories
Title
Measurements
OG00034.4
OG00133.5
OG00231.5
Secondary
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had >=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and >=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)*100. ACR70 Responder: had >=70% improvement from baseline in both TJ and SJ counts and >=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
All randomized participants with at least 5/68 TJ and 5/66 SJ at baseline and with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.
Posted
Number
percentage of participants
Up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
Secondary
Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If >=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR-N data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)
Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable tender joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
joint count
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)
Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable swollen joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
joint count
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Secondary
Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)
Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant's assessment of pain data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
millimeters
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant's global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
millimeters
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)
Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable physician's global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
millimeters
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants, even if participant did not take assigned treatment, did not receive correct treatment, or otherwise did not follow protocol, with evaluable DAS28-CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable HAQ-DI data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
Secondary
Time to American College of Rheumatology 20% (ACR20) Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.
Posted
Median
95% Confidence Interval
weeks
Baseline through 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
Secondary
Probability of an ACR20 Response by 24 Weeks
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.
Posted
Number
probability of response
Baseline through 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
Secondary
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response
EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP <=5.1 and DAS28-CRP change <-0.6; or DAS28-CRP >5.1 and DAS28-CRP change <-1.2. EULAR28 responder index is defined as good response: DAS28-CRP <=3.2 and DAS28-CRP change <-1.2; moderate response: DAS28-CRP change <-1.2 except cases defined in good response; or DAS28-CRP <=5.1 and DAS28-CRP change <-0.6 and >-1.2. EULAR Remission is defined as a DAS28-CRP score of <2.6.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Number
percentage of participants
Up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical health [PCS]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable SF-36 domain and summary scores. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint
CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
milligrams per liter (mg/L)
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Secondary
Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants who received at least 1 dose of study treatment with evaluable absolute B-cell data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.
Posted
Least Squares Mean
Standard Error
cells per microliter
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
Secondary
Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
All randomized participants who received at least 1 dose of study treatment with evaluable serum immunoglobulin (Ig) data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values.
Posted
Least Squares Mean
Standard Error
grams per liter (g/L)
Baseline, up to 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
Secondary
Population Pharmacokinetics (PK)
Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.
Participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.
Posted
Mean
95% Confidence Interval
milliliter per hour (mL/h)
Baseline through 24 weeks
ID
Title
Description
OG000
LY2127399
120 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
90 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Developing Anti-LY2127399 Antibodies
LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
All randomized participants who received at least 1 dose of study treatment.
Posted
Number
percentage of participants
Baseline through 24 weeks
ID
Title
Description
OG000
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
120 mg LY2127399, Randomized Treatment Period
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.
The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.
14
379
174
379
EG001
90 mg LY2127399, Randomized Treatment Period
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.
8
371
154
371
EG002
Placebo, Randomized Treatment Period
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
The Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.
7
250
98
250
EG003
120 mg LY2127399, Rescue Period
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.
5
81
23
81
EG004
90 mg LY2127399, Rescue Period
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.
0
72
16
72
EG005
Placebo, Rescue Period
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.
0
56
9
56
EG006
120 mg LY2127399, Follow-up Period
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
0
40
12
40
EG007
90 mg LY2127399, Follow-up Period
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
4
45
17
45
EG008
Placebo, Follow-up Period
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
3
37
13
37
EG009
120 mg LY2127399 to 90 mg LY212739 (Week 16), Follow-up Period
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
1
7
5
7
EG010
Placebo to 90 mg LY2127399 (Week 16), Follow-up Period
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
2
12
2
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected72 at risk
EG0050 events0 affected56 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected45 at risk
EG0080 events0 affected37 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected12 at risk
Atrioventricular block complete
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Device related infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Joint dislocation postoperative
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Juvenile arthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0010 events0 affected371 at risk
EG0023 events3 affected250 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Spindle cell sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Peripheral sensorimotor neuropathy
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0011 events1 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Dysfunctional uterine bleeding
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0010 events0 affected292 at risk
EG0021 events1 affected208 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected379 at risk
EG0014 events4 affected371 at risk
EG0021 events1 affected250 at risk
EG0032 events2 affected81 at risk
EG0042 events2 affected72 at risk
EG0050 events0 affected56 at risk
EG0060 events0 affected40 at risk
EG0071 events1 affected45 at risk
EG0080 events0 affected37 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected12 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Mitral valve prolapse
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0010 events0 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Macular pigmentation
Eye disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected379 at risk
EG0017 events6 affected371 at risk
EG0023 events2 affected250 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0016 events5 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0010 events0 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0008 events8 affected379 at risk
EG00110 events8 affected371 at risk
EG0024 events3 affected250 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0011 events1 affected371 at risk
EG0023 events3 affected250 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0009 events9 affected379 at risk
EG00110 events8 affected371 at risk
EG0028 events6 affected250 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0013 events3 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0004 events4 affected379 at risk
EG0013 events3 affected371 at risk
EG0023 events3 affected250 at risk
EG003
Fatigue
General disorders
MedDRA 15.1
Systematic Assessment
EG0005 events5 affected379 at risk
EG0015 events5 affected371 at risk
EG0027 events7 affected250 at risk
EG003
Injection site erythema
General disorders
MedDRA 15.1
Systematic Assessment
EG0009 events4 affected379 at risk
EG00127 events10 affected371 at risk
EG0023 events2 affected250 at risk
EG003
Injection site reaction
General disorders
MedDRA 15.1
Systematic Assessment
EG00010 events8 affected379 at risk
EG00134 events11 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Pyrexia
General disorders
MedDRA 15.1
Systematic Assessment
EG0007 events7 affected379 at risk
EG00110 events10 affected371 at risk
EG0026 events5 affected250 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG00014 events14 affected379 at risk
EG0019 events9 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0013 events2 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0014 events4 affected371 at risk
EG0024 events4 affected250 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0012 events2 affected371 at risk
EG0023 events2 affected250 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG00020 events17 affected379 at risk
EG00116 events14 affected371 at risk
EG00210 events9 affected250 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0005 events5 affected379 at risk
EG0012 events2 affected371 at risk
EG0024 events3 affected250 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0006 events6 affected379 at risk
EG00112 events11 affected371 at risk
EG0026 events6 affected250 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG00015 events12 affected379 at risk
EG00129 events28 affected371 at risk
EG00212 events10 affected250 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0008 events7 affected379 at risk
EG0015 events4 affected371 at risk
EG0028 events6 affected250 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected379 at risk
EG0012 events2 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0011 events1 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0006 events6 affected379 at risk
EG0016 events4 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0004 events4 affected379 at risk
EG0014 events3 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0013 events2 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Computerised tomogram abnormal
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 15.1
Systematic Assessment
EG0005 events5 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Vitamin d decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Weight increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG00011 events11 affected379 at risk
EG0016 events6 affected371 at risk
EG0029 events8 affected250 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG00011 events10 affected379 at risk
EG0019 events9 affected371 at risk
EG0023 events3 affected250 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0013 events3 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0012 events2 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0005 events4 affected379 at risk
EG0011 events1 affected371 at risk
EG0026 events6 affected250 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0004 events4 affected379 at risk
EG0013 events2 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG00017 events17 affected379 at risk
EG00112 events10 affected371 at risk
EG00213 events13 affected250 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0011 events1 affected371 at risk
EG0024 events2 affected250 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG00012 events12 affected379 at risk
EG0017 events5 affected371 at risk
EG0023 events3 affected250 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG00017 events16 affected379 at risk
EG00116 events13 affected371 at risk
EG0029 events6 affected250 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected379 at risk
EG0012 events2 affected371 at risk
EG0024 events3 affected250 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0007 events7 affected379 at risk
EG0014 events4 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0005 events5 affected379 at risk
EG00110 events10 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0021 events1 affected250 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Balanitis
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected42 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected293 at risk
EG0010 events0 affected292 at risk
EG0020 events0 affected208 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0004 events4 affected379 at risk
EG0016 events5 affected371 at risk
EG0022 events2 affected250 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected379 at risk
EG0011 events1 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected379 at risk
EG0014 events4 affected371 at risk
EG0026 events6 affected250 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0007 events7 affected379 at risk
EG0018 events8 affected371 at risk
EG0027 events6 affected250 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected379 at risk
EG0010 events0 affected371 at risk
EG0020 events0 affected250 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C575974
tabalumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
51.4
± 11.8
209
BG003797
Male
BG00086
BG00179
BG00242
BG003207
24
BG003109
Not Hispanic or Latino
BG000193
BG001185
BG002133
BG003511
Unknown or Not Reported
BG000148
BG001142
BG00294
BG003384
9
BG00343
Asian
BG00096
BG00193
BG00259
BG003248
Native Hawaiian or Other Pacific Islander
BG0001
BG0011
BG0020
BG0032
Black or African American
BG00012
BG00113
BG00214
BG00339
White
BG000254
BG001235
BG002162
BG003651
More than one race
BG0002
BG0019
BG0026
BG00317
Unknown or Not Reported
BG0001
BG0012
BG0021
BG0034
83
BG003334
Argentina
Title
Measurements
BG0007
BG0016
BG0025
BG00318
Colombia
Title
Measurements
BG0009
BG0019
BG0025
BG00323
Mexico
Title
Measurements
BG00020
BG00125
BG00215
BG00360
Bulgaria
Title
Measurements
BG00013
BG00113
BG00212
BG00338
Croatia
Title
Measurements
BG0002
BG0011
BG0023
BG0036
Hungary
Title
Measurements
BG0003
BG00112
BG0026
BG00321
Lithuania
Title
Measurements
BG00014
BG00110
BG00211
BG00335
Poland
Title
Measurements
BG00027
BG00122
BG00212
BG00361
Romania
Title
Measurements
BG0000
BG0011
BG0023
BG0034
Russia
Title
Measurements
BG00014
BG00113
BG0028
BG00335
Slovakia
Title
Measurements
BG0008
BG0013
BG0022
BG00313
Ukraine
Title
Measurements
BG00016
BG00115
BG0026
BG00337
Australia
Title
Measurements
BG0002
BG0013
BG0022
BG0037
India
Title
Measurements
BG00014
BG0019
BG0029
BG00332
Japan
Title
Measurements
BG00044
BG00142
BG00228
BG003114
South Korea
Title
Measurements
BG0007
BG0016
BG0025
BG00318
Malaysia
Title
Measurements
BG0002
BG0014
BG0021
BG0037
New Zealand
Title
Measurements
BG0006
BG0012
BG0026
BG00314
Sri Lanka
Title
Measurements
BG0004
BG0014
BG0022
BG00310
South Africa
Title
Measurements
BG00032
BG00138
BG00224
BG00394
Taiwan
Title
Measurements
BG0009
BG00111
BG0023
BG00323
23.7
± 17.1
BG00222.8± 15.2
BG00323.2± 16.0
15.3
± 11.6
BG00214.3± 10.6
BG00314.8± 11.4
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000320
OG001316
OG002213
Title
Denominators
Categories
ACR50
Title
Measurements
OG00011.6
OG00111.7
OG00212.7
ACR70
Title
Measurements
OG0004.7
OG0016.3
OG0024.7
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000318
OG001314
OG002211
Title
Denominators
Categories
Title
Measurements
OG000-11.5± 4.6
OG001-9.5± 4.6
OG002-11.5± 5.0
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000318
OG001315
OG002211
Title
Denominators
Categories
Title
Measurements
OG000-1.61± 1.30
OG001-1.63± 1.31
OG002-2.11± 1.40
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000318
OG001315
OG002211
Title
Denominators
Categories
Title
Measurements
OG000-2.59± 0.97
OG001-3.18± 0.99
OG002-3.59± 1.05
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000313
OG001312
OG002208
Title
Denominators
Categories
Title
Measurements
OG000-9.0± 2.3
OG001-9.6± 2.4
OG002-6.9± 2.5
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000317
OG001313
OG002211
Title
Denominators
Categories
Title
Measurements
OG000-10.2± 2.3
OG001-10.2± 2.4
OG002-6.9± 2.5
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000308
OG001306
OG002201
Title
Denominators
Categories
Title
Measurements
OG000-10.0± 2.3
OG001-12.4± 2.4
OG002-9.7± 2.5
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000376
OG001369
OG002249
Title
Denominators
Categories
Title
Measurements
OG000-0.42± 0.12
OG001-0.49± 0.12
OG002-0.41± 0.13
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000317
OG001314
OG002211
Title
Denominators
Categories
Title
Measurements
OG000-0.21± 0.05
OG001-0.18± 0.05
OG002-0.15± 0.05
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Units
Counts
Participants
OG000318
OG001315
OG002210
Title
Denominators
Categories
Title
Measurements
OG00016.7(16.1 to 20.1)
OG00116.1(12.1 to 20.1)
OG00216.4(15.9 to 23.6)
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Units
Counts
Participants
OG000318
OG001315
OG002210
Title
Denominators
Categories
Title
Measurements
OG0000.612
OG0010.611
OG0020.608
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000318
OG001314
OG002211
Title
Denominators
Categories
Title
Measurements
OG00050.3
OG00149.7
OG00246.4
OG001
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000311
OG001304
OG002206
Title
Denominators
Categories
Physical functioning domain
Title
Measurements
OG0002.07± 0.84
OG0013.14± 0.85
OG0021.48± 0.91
Bodily pain domain
Title
Measurements
OG0001.62± 0.82
OG0012.08± 0.83
OG0021.34± 0.89
Role limitations due to physical problems domain
Title
Measurements
OG0001.60± 0.83
OG0012.40± 0.84
OG0021.65± 0.91
Role limitations due to emotional problems domain
Title
Measurements
OG0003.30± 1.01
OG0013.23± 1.02
OG0023.11± 1.09
General health perception domain
Title
Measurements
OG0001.93± 0.76
OG0011.99± 0.77
OG0021.81± 0.82
Mental health domain
Title
Measurements
OG0003.09± 0.89
OG0013.00± 0.90
OG0022.31± 0.97
Social function domain
Title
Measurements
OG0001.17± 1.00
OG0011.24± 1.01
OG0020.33± 1.08
Vitality domain
Title
Measurements
OG0002.85± 0.87
OG0012.58± 0.88
OG0022.22± 0.94
Physical component summary score
Title
Measurements
OG0001.19± 0.79
OG0012.10± 0.79
OG0021.14± 0.85
Mental component summary score
Title
Measurements
OG0003.18± 0.95
OG0012.68± 0.96
OG0022.54± 1.03
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000318
OG001315
OG002211
Title
Denominators
Categories
Title
Measurements
OG0002.69± 1.42
OG0011.92± 1.44
OG0021.76± 1.54
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
Units
Counts
Participants
OG000376
OG001370
OG002248
Title
Denominators
Categories
Title
Measurements
OG000-50.5± 19.4
OG001-74.4± 19.3
OG002-0.7± 20.9
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Units
Counts
Participants
OG000374
OG001369
OG002248
Title
Denominators
Categories
Immunoglobulin G
Title
Measurements
OG000-0.813± 0.165
OG001-0.758± 0.165
OG0020.117± 0.178
Immunoglobulin A
Title
Measurements
OG000-0.209± 0.044
OG001-0.224± 0.044
OG0020.139± 0.047
Immunoglobulin M
Title
Measurements
OG000-0.267± 0.026
OG001-0.275± 0.025
OG002-0.049± 0.028
777
Title
Denominators
Categories
Title
Measurements
OG0003.60± 2.54(3.44 to 3.78)
OG002
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.