A Study in Participants With Rheumatoid Arthritis | NCT01202773 | Trialant
NCT01202773
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
May 14, 2018Actual
Enrollment
456Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
LY2127399
Placebo Q4W
Placebo Q2W
Countries
United States
Argentina
Australia
Brazil
Colombia
France
Germany
Greece
Italy
Japan
Malaysia
Mexico
New Zealand
Poland
Russia
South Africa
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01202773
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13732
Secondary IDs
ID
Type
Description
Link
H9B-MC-BCDV
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Participants With Rheumatoid Arthritis
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)
Acronym
FLEX V
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
May 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Terminated not based on safety concerns, but due to insufficient efficacy.
Expanded Access Info
No
Start Date
Jan 2011
Primary Completion Date
Mar 2013Actual
Completion Date
Jan 2014Actual
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
May 11, 2018
Results First Posted Date
May 14, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 14, 2014
Certification/Extension First Submitted that Passed QC Review
Apr 14, 2014
Certification/Extension First Posted Date
May 7, 2014Estimated
Last Update Submitted Date
May 11, 2018
Last Update Posted Date
May 14, 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 in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.
This study is comprised of 2 periods:
Period 1: 24-week blinded treatment
Period 2: 48-week post-treatment follow-up
Detailed Description
Not provided
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
456Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
120 milligrams (mg) LY2127399
Experimental
Given every 4 weeks (Q4W) for 24 weeks. Participants receive a 240-mg loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period.
At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Drug: LY2127399
Drug: Placebo Q4W
90 mg LY2127399
Experimental
Given Q2W for 24 weeks. Participants receive a 180-mg loading dose when initiating treatment.
At Week 16, both responders and NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Drug: LY2127399
Placebo
Placebo Comparator
Given Q2W for 24 weeks. Participants receive 2 injections of placebo when initiating treatment.
At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR will receive a 180-mg loading dose of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Drug: LY2127399
Drug: Placebo Q2W
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2127399
Drug
Administered Subcutaneously (SC)
120 milligrams (mg) LY2127399
90 mg LY2127399
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥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 NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Baseline through Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a ≥50% improvement from baseline in both 68 TJC and 66 SJC and a ≥50% improvement in at least 3 of 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 a ≥70% improvement from baseline in both TJC and SJC and a ≥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 NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA of more than 6 months and less than 15 years
At least 8 tender and swollen joints
An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
Woman must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria:
Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks
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 ago, 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 received 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.
Schiff M, Combe B, Dorner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study had a treatment period (Weeks 0-24) and a post-treatment follow-up period (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
120 mg LY2127399
A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W) for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W 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
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
Not provided
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 Q4W
Drug
Administered SC
120 milligrams (mg) LY2127399
Placebo Q2W
Drug
Administered SC
Placebo
Baseline through Week 24
American College of Rheumatology Percent Improvement (ACR-N)
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change 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. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.
Baseline through Week 24
Change From Baseline to Week 24 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 was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Participant's assessment of their current arthritis pain using 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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)
Participant's assessment of their current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)
Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (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), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). 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 from 1.0 to 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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) * 100.
Baseline through Week 24
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
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, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If < 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)
The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Time to ACR20 Response
Baseline through Week 24
Change From Baseline to Week 24 in Absolute 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 the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
Immunoglobulin (Ig), 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 in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Baseline, Week 24
Population Pharmacokinetics (PK): Constant Clearance
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Baseline through Week 24
Percentage of Participants Developing Anti-LY2127399 Antibodies
Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
Baseline through Week 24
Change From Baseline to Week 24 in CRP
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 and region as fixed factors and baseline as a covariate.
Baseline, Week 24
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.
Huntsville
Alabama
35810
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.
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
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.
Jonesboro
Arkansas
72401
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.
Little Rock
Arkansas
72205
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.
Escondido
California
92027
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.
Fresno
California
93720
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.
Hemet
California
92543
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.
Huntington Beach
California
92646
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.
La Mesa
California
91942
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.
Loma Linda
California
92354
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.
Long Beach
California
90808
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.
Los Angeles
California
90022
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.
San Diego
California
92108
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.
Santa Monica
California
90404
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
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.
Upland
California
91786
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.
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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Denver
Colorado
80209
United States
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Lewes
Delaware
19958
United States
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Aventura
Florida
33180
United States
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Boca Raton
Florida
33486
United States
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Boynton Beach
Florida
33472
United States
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DeBary
Florida
32713
United States
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Miami
Florida
33173
United States
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New Port Richey
Florida
34652
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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Tamarac
Florida
33321
United States
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Tampa
Florida
33609
United States
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Venice
Florida
34292
United States
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Vero Beach
Florida
32960
United States
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West Palm Beach
Florida
33401
United States
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Atlanta
Georgia
30342
United States
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Decatur
Georgia
30033
United States
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Dunwoody
Georgia
30338
United States
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Gainesville
Georgia
30501
United States
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Marietta
Georgia
30060
United States
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Stockbridge
Georgia
30281
United States
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Eagle
Idaho
83616
United States
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Idaho Falls
Idaho
83404
United States
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Peoria
Illinois
61636
United States
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Rock Island
Illinois
61201
United States
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Brownsburg
Indiana
46112
United States
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Evansville
Indiana
47714
United States
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Indianapolis
Indiana
46227
United States
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Kansas City
Kansas
66160
United States
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Bowling Green
Kentucky
42101
United States
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Lexington
Kentucky
40504
United States
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Owensboro
Kentucky
42303
United States
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Monroe
Louisiana
71203
United States
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Wheaton
Maryland
20902
United States
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Haverhill
Massachusetts
01830
United States
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Worcester
Massachusetts
01605
United States
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Saint Clair Shores
Michigan
48081
United States
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Edina
Minnesota
55435
United States
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Flowood
Mississippi
39232
United States
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Jackson
Mississippi
39202
United States
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Cape Girardeau
Missouri
63703
United States
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Florissant
Missouri
63031
United States
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St Louis
Missouri
63131
United States
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Kalispell
Montana
59901
United States
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Las Vegas
Nevada
89128
United States
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Nashua
New Hampshire
03060
United States
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Berkeley Heights
New Jersey
07922
United States
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Clifton
New Jersey
07012
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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Charlotte
North Carolina
28210
United States
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Greensboro
North Carolina
27408
United States
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Hickory
North Carolina
28601
United States
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Sanford
North Carolina
27330
United States
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Bismarck
North Dakota
58502
United States
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Cincinnati
Ohio
45242
United States
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Cleveland
Ohio
44109
United States
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Oklahoma City
Oklahoma
73104
United States
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Tulsa
Oklahoma
74104
United States
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Bethlehem
Pennsylvania
18017
United States
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Erie
Pennsylvania
16508
United States
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Limerick
Pennsylvania
19468
United States
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Wexford
Pennsylvania
15090
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
29651
United States
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Myrtle Beach
South Carolina
29572
United States
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Taylors
South Carolina
29687
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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Houston
Texas
77008
United States
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Lubbock
Texas
79424
United States
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Mesquite
Texas
75150
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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Burlington
Vermont
05401
United States
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Chesapeake
Virginia
23320
United States
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Danville
Virginia
24541
United States
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Richmond
Virginia
23225
United States
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Spokane
Washington
99204
United States
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Tacoma
Washington
98405
United States
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Wenatchee
Washington
98801
United States
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Clarksburg
West Virginia
26301
United States
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Milwaukee
Wisconsin
53226
United States
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Racine
Wisconsin
53406
United States
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Buenos Aires
C1280AEB
Argentina
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Córdoba
X5016KEH
Argentina
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Luján
6700
Argentina
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Mar del Plata
B7600FZN
Argentina
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Quilmes
B1878DVC
Argentina
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San Isidro
B1642AKG
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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Campinas
13059-000
Brazil
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Goiânia
74110-120
Brazil
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Juiz de Fora
36010-570
Brazil
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São Paulo
04266-010
Brazil
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Bogotá
Colombia
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Medellín
Colombia
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Montpellier
34295
France
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Nice
06202
France
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Orléans
45000
France
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Paris
75018
France
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Saint-Etienne
42055
France
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Strasbourg
67 098
France
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Toulouse
31059
France
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Bad Doberan
18209
Germany
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Bad Nauheim
61231
Germany
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Baden-Baden
76530
Germany
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Berlin
14059
Germany
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Cologne
50924
Germany
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Dresden
01307
Germany
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Erlangen
91054
Germany
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Frankfurt
60590
Germany
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Göttingen
37075
Germany
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Munich
80639
Germany
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Haidari/Athens
12462
Greece
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Heraklion
71110
Greece
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Larissa
411 10
Greece
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Thessaloniki
54642
Greece
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Arenzano
16011
Italy
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Fukuoka
807-8555
Japan
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Gunma
370-0053
Japan
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Hyōgo
673-1462
Japan
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Kanagawa
216-8511
Japan
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Miyazaki
880-0122
Japan
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Nagasaki
852-8501
Japan
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Okayama
700-8558
Japan
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Tokyo
162
Japan
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Perak
30990
Malaysia
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Putrajaya
62250
Malaysia
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Sarawak
93586
Malaysia
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Chihuahua City
31000
Mexico
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Col Centro
80000
Mexico
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Guadalajara
44620
Mexico
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Mexico City
03720
Mexico
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Monterrey
64000
Mexico
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Querétaro
76000
Mexico
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San Luis Potosí City
78200
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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Lublin
20-607
Poland
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Płock
09-400
Poland
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Torun
87-100
Poland
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Warsaw
02-118
Poland
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Kazan'
420029
Russia
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Khanty-Mansiysk
628012
Russia
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Kursk
305007
Russia
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Moscow
115093
Russia
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Nizhny Novgorod
603005
Russia
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Petrozavodsk
185019
Russia
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Saint Petersburg
191104
Russia
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Stavropol
355017
Russia
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Voronezh
394066
Russia
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Benoni
1500
South Africa
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Bloemfontein
9301
South Africa
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Limpopo
0380
South Africa
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Incheon
400-711
South Korea
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Seoul
150-713
South Korea
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Suwon
442-721
South Korea
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A Coruña
15006
Spain
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Barcelona
08034
Spain
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Bilboa
48013
Spain
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Madrid
28046
Spain
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Manises
46940
Spain
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Santiago de Compostela
15706
Spain
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Keelung
204
Taiwan
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Taichung
40705
Taiwan
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Taipei
112
Taiwan
FG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.
At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
FG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
FG000153 subjects
FG001148 subjects
FG002155 subjects
Received at Least 1 Dose of Study Drug
FG000153 subjects
FG001147 subjects
FG002154 subjects
Week 16 NR
FG00023 subjects
FG00133 subjects
FG00237 subjects
Post-Treatment Follow-Up Population
FG00046 subjects
FG00136 subjects
FG00251 subjects
COMPLETED
FG00096 subjectsThose who completed 24-week treatment period including both Week 16 responders and NR.
FG001105 subjectsThose who completed 24-week treatment period including both Week 16 responders and NR.
FG002100 subjectsThose who completed 24-week treatment period including both Week 16 responders and NR.
NOT COMPLETED
FG00057 subjects
FG00143 subjects
FG00255 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0015 subjects
FG0025 subjects
Lack of Efficacy
FG0005 subjects
FG0014 subjects
FG0029 subjects
Entry Criteria Not Met
FG0002 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0022 subjects
Withdrawal by Subject
FG00013 subjects
FG0016 subjects
FG0025 subjects
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
Protocol Violation
FG00011 subjects
FG0016 subjects
FG00210 subjects
Sponsor Decision
FG00019 subjects
FG00120 subjects
FG00223 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
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
BG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.
At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
BG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000153
BG001148
BG002155
BG003456
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
BG00054.2± 11.6
BG00151.3± 11.7
BG00254.0± 11.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000124
BG001126
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00039
BG00136
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0008
BG0019
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00089
BG00190
BG002
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
ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥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 NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.
Posted
Number
percentage of participants
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001148
OG002155
Title
Denominators
Categories
Title
Measurements
OG00017.6
OG00124.3
OG00220.0
Secondary
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a ≥50% improvement from baseline in both 68 TJC and 66 SJC and a ≥50% improvement in at least 3 of 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 a ≥70% improvement from baseline in both TJC and SJC and a ≥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 NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.
Posted
Number
percentage of participants
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
American College of Rheumatology Percent Improvement (ACR-N)
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change 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. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.
All randomized participants with evaluable ACR-N data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
percentage of improvement
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
Change From Baseline to Week 24 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 was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
joint counts
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
joint counts
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Participant's assessment of their current arthritis pain using 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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
mm
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)
Participant's assessment of their current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
mm
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)
Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
mm
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
Secondary
Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (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), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). 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 from 1.0 to 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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
Secondary
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) * 100.
All randomized participants with evaluable EULAR response data. Modified Last Observation Carried Forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Number
percentage of participants
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
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, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If < 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
Secondary
Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)
The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Time to ACR20 Response
Zero participants analyzed. Time to ACR20 data not collected for analysis.
Posted
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in Absolute 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 the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
cells/microliter (cells/µL)
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
Immunoglobulin (Ig), 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 in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
grams/liter (g/L)
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Population Pharmacokinetics (PK): Constant Clearance
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.
Posted
Mean
Standard Error
milliliters/hour (mL/h)
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Developing Anti-LY2127399 Antibodies
Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.
Posted
Number
percentage of participants
Baseline through Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Secondary
Change From Baseline to Week 24 in CRP
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 and region as fixed factors and baseline as a covariate.
All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Posted
Least Squares Mean
Standard Error
milligrams/liter (mg/L)
Baseline, Week 24
ID
Title
Description
OG000
120 mg LY2127399
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
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
LY 120 mg Q4W, Randomized Treatment Period
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
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 NR.
7
153
71
153
EG001
LY 90 mg Q2W, Randomized Treatment Period
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
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 NR.
6
147
51
147
EG002
Placebo, Randomized Treatment Period
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
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 NR.
6
154
61
154
EG003
LY 120 mg Q4W, Rescue Period
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W 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 NR.
1
23
10
23
EG004
LY 90 mg Q2W, Rescue Period
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W 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 NR.
2
33
11
33
EG005
Placebo, Rescue Period
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W 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 NR.
1
37
16
37
EG006
LY 120 mg Q4W, Follow-up Period
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
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
43
6
43
EG007
LY 90 mg Q2W, Follow-up Period
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W 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
36
11
36
EG008
Placebo, Follow-up Period
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W 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.
3
44
14
44
EG009
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W 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.
0
3
0
3
EG010
Placebo to LY 90 mg Q2W (Week 16), Follow-up Period
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W 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.
0
7
1
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected37 at risk
EG0060 events0 affected43 at risk
EG0070 events0 affected36 at risk
EG0080 events0 affected44 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Abscess
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Device related infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Pyomyositis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Somatoform disorder
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0012 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Hypotension
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0022 events2 affected154 at risk
EG0031 events1 affected23 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected37 at risk
EG0061 events1 affected43 at risk
EG0070 events0 affected36 at risk
EG0081 events1 affected44 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0012 events2 affected147 at risk
EG0023 events3 affected154 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected153 at risk
EG0011 events1 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Oedema mouth
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Asthenia
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Chest pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Chills
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Injection site erythema
General disorders
MedDRA 16.0
Systematic Assessment
EG0002 events1 affected153 at risk
EG0013 events3 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Injection site pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0006 events2 affected153 at risk
EG00118 events5 affected147 at risk
EG00221 events4 affected154 at risk
EG003
Injection site reaction
General disorders
MedDRA 16.0
Systematic Assessment
EG0006 events4 affected153 at risk
EG00119 events7 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0014 events4 affected147 at risk
EG0023 events2 affected154 at risk
EG003
Pyrexia
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0011 events1 affected147 at risk
EG0023 events2 affected154 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Adenoiditis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0013 events3 affected147 at risk
EG0023 events3 affected154 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0013 events3 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected153 at risk
EG0012 events2 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0006 events5 affected153 at risk
EG0012 events2 affected147 at risk
EG0027 events7 affected154 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00010 events9 affected153 at risk
EG0017 events7 affected147 at risk
EG00211 events9 affected154 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 events5 affected153 at risk
EG0016 events6 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Lipase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Weight decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
White blood cell count increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected153 at risk
EG0013 events3 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0012 events2 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0011 events1 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0025 events4 affected154 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0009 events8 affected153 at risk
EG0017 events7 affected147 at risk
EG00213 events11 affected154 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0021 events1 affected154 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0011 events1 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Neoplasm prostate
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected29 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected153 at risk
EG0011 events1 affected147 at risk
EG0022 events2 affected154 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0008 events7 affected153 at risk
EG0012 events2 affected147 at risk
EG0025 events5 affected154 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0010 events0 affected147 at risk
EG0024 events4 affected154 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected124 at risk
EG0010 events0 affected125 at risk
EG0020 events0 affected130 at risk
EG003
Allergic cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected153 at risk
EG0011 events1 affected147 at risk
EG0023 events3 affected154 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected153 at risk
EG0011 events1 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected153 at risk
EG0011 events1 affected147 at risk
EG0024 events4 affected154 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected153 at risk
EG0010 events0 affected147 at risk
EG0020 events0 affected154 at risk
EG003
This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.
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
53.2
± 11.5
131
BG003381
Male
BG00029
BG00122
BG00224
BG00375
33
BG003108
Not Hispanic or Latino
BG00093
BG00195
BG002101
BG003289
Unknown or Not Reported
BG00021
BG00117
BG00221
BG00359
6
BG00323
Asian
BG00010
BG0019
BG00213
BG00332
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG00014
BG00116
BG00218
BG00348
White
BG000119
BG001108
BG002112
BG003339
More than one race
BG0000
BG0014
BG0022
BG0036
Unknown or Not Reported
BG0002
BG0012
BG0024
BG0038
89
BG003268
Taiwan
Title
Measurements
BG0000
BG0010
BG0021
BG0031
Greece
Title
Measurements
BG0002
BG0011
BG0021
BG0034
Spain
Title
Measurements
BG0002
BG0012
BG0022
BG0036
Russia
Title
Measurements
BG0006
BG0014
BG0024
BG00314
Colombia
Title
Measurements
BG00010
BG0017
BG00212
BG00329
France
Title
Measurements
BG0001
BG0011
BG0021
BG0033
Mexico
Title
Measurements
BG0003
BG0013
BG0022
BG0038
Argentina
Title
Measurements
BG0005
BG0014
BG0024
BG00313
Malaysia
Title
Measurements
BG0000
BG0010
BG0021
BG0031
Brazil
Title
Measurements
BG0007
BG0017
BG0027
BG00321
Poland
Title
Measurements
BG00014
BG00114
BG00214
BG00342
Australia
Title
Measurements
BG0000
BG0011
BG0022
BG0033
South Africa
Title
Measurements
BG0000
BG0010
BG0021
BG0031
Germany
Title
Measurements
BG0003
BG0014
BG0023
BG00310
New Zealand
Title
Measurements
BG0002
BG0012
BG0021
BG0035
Japan
Title
Measurements
BG0006
BG0016
BG0026
BG00318
South Korea
Title
Measurements
BG0003
BG0012
BG0024
BG0039
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001148
OG002155
Title
Denominators
Categories
ACR50
Title
Measurements
OG0007.2
OG0015.4
OG0023.9
ACR70
Title
Measurements
OG0002.6
OG0012.0
OG0020.6
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001146
OG002153
Title
Denominators
Categories
Title
Measurements
OG000-9.03± 4.00
OG001-8.03± 4.11
OG002-12.72± 4.00
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001147
OG002154
Title
Denominators
Categories
Title
Measurements
OG000-6.37± 1.40
OG001-6.08± 1.42
OG002-6.56± 1.38
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001147
OG002154
Title
Denominators
Categories
Title
Measurements
OG000-6.02± 0.98
OG001-5.64± 1.00
OG002-5.41± 0.98
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001146
OG002153
Title
Denominators
Categories
Title
Measurements
OG000-9.89± 2.10
OG001-9.15± 2.15
OG002-5.76± 2.10
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001146
OG002153
Title
Denominators
Categories
Title
Measurements
OG000-11.29± 2.14
OG001-8.72± 2.19
OG002-7.12± 2.13
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000147
OG001140
OG002150
Title
Denominators
Categories
Title
Measurements
OG000-15.90± 2.16
OG001-16.38± 2.23
OG002-13.17± 2.13
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001146
OG002153
Title
Denominators
Categories
Title
Measurements
OG000-0.13± 0.05
OG001-0.09± 0.05
OG002-0.08± 0.05
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000152
OG001146
OG002152
Title
Denominators
Categories
Title
Measurements
OG000-0.76± 0.12
OG001-0.79± 0.13
OG002-0.72± 0.12
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000152
OG001146
OG002152
Title
Denominators
Categories
Good
Title
Measurements
OG00011.8
OG0019.6
OG0028.6
Moderate
Title
Measurements
OG00036.2
OG00136.3
OG00236.2
No response
Title
Measurements
OG00052.0
OG00154.1
OG00255.3
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000146
OG001138
OG002149
Title
Denominators
Categories
Physical Functioning
Title
Measurements
OG0001.81± 0.78
OG0011.78± 0.82
OG0021.00± 0.77
Bodily Pain
Title
Measurements
OG0002.36± 0.75
OG0012.95± 0.78
OG0021.97± 0.74
Role Limitations due to Physical Problems
Title
Measurements
OG0001.92± 0.72
OG0012.08± 0.75
OG0020.35± 0.72
Role Limitations due to Emotional Problems
Title
Measurements
OG0001.07± 0.97
OG0012.55± 1.01
OG0021.19± 0.96
General Health Perception
Title
Measurements
OG0001.90± 0.64
OG0010.91± 0.67
OG0021.88± 0.64
Mental Health
Title
Measurements
OG0000.83± 0.85
OG0011.57± 0.88
OG0020.98± 0.84
Social Function
Title
Measurements
OG0002.51± 0.87
OG0011.68± 0.91
OG0021.32± 0.86
Vitality
Title
Measurements
OG0002.71± 0.77
OG0012.40± 0.80
OG0022.05± 0.76
PCS
Title
Measurements
OG0002.30± 0.71
OG0011.83± 0.74
OG0021.21± 0.71
MCS
Title
Measurements
OG0001.22± 0.87
OG0011.86± 0.90
OG0021.38± 0.86
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000146
OG001138
OG002149
Title
Denominators
Categories
Fatigue - Now
Title
Measurements
OG000-0.68± 0.12
OG001-0.55± 0.12
OG002-0.60± 0.12
Fatigue - Usual
Title
Measurements
OG000-0.65± 0.11
OG001-0.58± 0.11
OG002-0.56± 0.11
Fatigue - Worst
Title
Measurements
OG000-0.75± 0.12
OG001-0.65± 0.12
OG002-0.72± 0.12
General Activity
Title
Measurements
OG000-0.55± 0.12
OG001-0.50± 0.12
OG002-0.52± 0.12
Mood
Title
Measurements
OG000-0.54± 0.12
OG001-0.35± 0.12
OG002-0.35± 0.12
Walking Ability
Title
Measurements
OG000-0.53± 0.12
OG001-0.38± 0.13
OG002-0.36± 0.12
Normal Work
Title
Measurements
OG000-0.60± 0.12
OG001-0.46± 0.12
OG002-0.42± 0.12
Relations with Other People
Title
Measurements
OG000-0.41± 0.12
OG001-0.43± 0.12
OG002-0.29± 0.12
Enjoyment of Life
Title
Measurements
OG000-0.53± 0.13
OG001-0.55± 0.13
OG002-0.41± 0.13
Fatigue Impact Subscale
Title
Measurements
OG000-0.52± 0.11
OG001-0.43± 0.11
OG002-0.39± 0.11
OG001
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000146
OG001138
OG002149
Title
Denominators
Categories
Pain - Worst
ParticipantsOG000146
ParticipantsOG001138
ParticipantsOG002149
Title
Measurements
OG000-0.9± 0.2
OG001-0.8± 0.2
OG002-0.4± 0.2
Pain - Least
ParticipantsOG000146
ParticipantsOG001138
ParticipantsOG002149
Title
Measurements
OG000
Pain - Average
ParticipantsOG000146
ParticipantsOG001138
ParticipantsOG002149
Title
Measurements
OG000
Pain - Now
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
General Activity
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Mood
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Walking Ability
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Normal Work
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Relations with Other People
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Sleep
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Enjoyment of Life
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
Pain Interference Score
ParticipantsOG000146
ParticipantsOG001137
ParticipantsOG002149
Title
Measurements
OG000
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000141
OG001138
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-20.6± 11.5
OG001-1.0± 11.7
OG002-18.0± 11.9
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000151
OG001147
OG002154
Title
Denominators
Categories
Title
Measurements
OG000-55.3± 9.9
OG001-65.8± 10.1
OG0023.2± 9.8
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000151
OG001146
OG002153
Title
Denominators
Categories
IgA
Title
Measurements
OG000-0.330± 0.049
OG001-0.324± 0.050
OG0020.003± 0.049
IgG
Title
Measurements
OG000-0.955± 0.161
OG001-0.978± 0.163
OG0020.058± 0.158
IgM
Title
Measurements
OG000-0.273± 0.043
OG001-0.239± 0.044
OG002-0.019± 0.042
OG000309
Title
Denominators
Categories
Title
Measurements
OG0004.16± 3.58(3.44 to 3.78)
OG002
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
Units
Counts
Participants
OG000153
OG001147
OG002154
Title
Denominators
Categories
Title
Measurements
OG0003.9
OG0014.8
OG0023.9
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.