A Rheumatoid Arthritis Study in Participants on a Backgro... | NCT01198002

ID	Type	Description	Link
H9B-MC-BCDM	Other Identifier	Eli Lilly and Company
CTRI/2011/07/001870	Registry Identifier	Clinical Trials Registry India

Label	Type	Description	Intervention Names
120 milligrams (mg) LY2127399	Experimental	Given every 4 weeks (Q4W) for 100 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 Weeks 16 and 52, 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 100-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 100-week treatment period.	Drug: LY2127399 Drug: Placebo Q4W Drug: Methotrexate
90 mg LY2127399	Experimental	Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment. At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, 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 100-week treatment period.	Drug: LY2127399 Drug: Methotrexate
Placebo	Placebo Comparator	Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks. At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. At Week 16, NR will receive 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 100-week treatment period.

Name	Type	Description	Arm Group Labels	Other Names
LY2127399	Drug	Administered Subcutaneously (SC)	120 milligrams (mg) LY2127399 90 mg LY2127399 Placebo

Measure	Description	Time Frame
Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24	ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All 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 24 weeks
Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)	The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.	Baseline, 52 Weeks
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.

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 ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥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 ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All 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 Weeks 24 and 52 endpoints.

Measure	Description	Time Frame
Number of Participants Who Died During Post-Treatment Follow-Up Period		Discontinuation from study treatment up to 48 weeks during follow-up period

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

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Birmingham	Alabama	35216

PubMed Identifier	Type	Citation	Retractions
25873635	Derived	Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.

ID	Title	Description
FG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

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% Response (ACR20) at Week 24

ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All 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 24 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG002	Placebo	Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.

Units	Counts
Participants	OG000330 OG001332 OG002335

Title

Denominators

Categories

Title	Measurements
	OG00029.7 OG00132.8 OG00225.1

Primary

Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.

All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 52 Weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Primary

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. 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

units on a scale

Baseline, 24 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

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 ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥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 ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All 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 Weeks 24 and 52 endpoints.

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 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline 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 (mg/L)], and participant's global assessment of disease activity using visual analog scale (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 1.0-9.4, 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response

EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. 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 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores 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 were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores 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. Higher score indicated 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score

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, Item 1 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline 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 the 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001

Secondary

Change From Baseline 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 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 were 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks

Zero participants analyzed. Per protocol and statistical analysis plan (SAP) amendments, the major clinical response classification was not collected for analysis.

Posted

Baseline through 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.

All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Posted

Number

percentage of participants

Baseline through 24 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Secondary

Change From Baseline to Week 52 in B Cell Subset Counts

B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). 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 B cell subset counts 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

cells/microliter (cells/µL)

Baseline, 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399

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

95% Confidence Interval

milliliter per hour (mL/h)

Baseline through 52 weeks

ID	Title	Description
OG000	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 100 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 100 weeks. At Weeks 16 and 52, 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 100-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 100-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 100-week treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants Developing Anti-LY2127399 Antibodies

Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or 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 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001

Secondary

Percentage of Participants With No Structural Progression at Week 52

No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.

All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Posted

Number

percentage of participants

Baseline through 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Secondary

Change From Baseline to Week 24 in mTSS

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 24 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Secondary

Change From Baseline in Serum Immunoglobulin (Ig) Levels

Immunoglobulins (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 serum immunoglobulin G (IgG), immunoglobulin A (IgA), 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, 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399

Secondary

Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

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 TJ count, b) % change in SJ count, 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. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.

All randomized participants with evaluable ACR-N 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

percentage of improvement

Baseline through 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001

Secondary

Change From Baseline 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline 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

units on a scale

Baseline, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline 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

Baseline, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399

Secondary

Change From Baseline 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

Baseline, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399

Secondary

Change From Baseline to Week 52 in HAQ-DI

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, 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Change From Baseline to Week 52 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. 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, 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399

Secondary

Percentage of Participants With ACR20 at Week 52

ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and 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 52 endpoint.

Posted

Number

percentage of participants

Baseline through 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Secondary

Time to ACR20 Response

ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.

All randomized participants with evaluable ACR20 responder data. The number of participants censored are 128 (120 mg LY2127399), 123 (90 mg LY2127399) and 162 (placebo).

Posted

Median

95% Confidence Interval

weeks

Baseline through 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Secondary

Change From Baseline 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, 24 weeks and 52 weeks

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2.

Other Pre-specified

Number of Participants Who Died During Post-Treatment Follow-Up Period

All randomized participants who received at least 1 dose of study drug and entered post-treatment follow-up period.

Posted

Count of Participants

Participants

Discontinuation from study treatment up to 48 weeks during follow-up period

ID	Title	Description
OG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.
OG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LY 120 mg Q4W, Randomized Treatment Period 1	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 52 weeks during Treatment Period 1. 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 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.	19	345	137	345
EG001	LY 90 mg Q2W, Randomized Treatment Period 1	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 52 weeks during Treatment Period 1. 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 Treatment Period 1. The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.	17	345	117	345
EG002	Placebo, Randomized Treatment Period 1	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. The Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.	17	348	129	348
EG003	LY 120 mg Q4W to LY 90 mg Q2W (Week 16), 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 during Treatment Period 1. 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 52-week Treatment Period 1. The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.	3	58	22	58
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 during Treatment Period 1. 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 52-week Treatment Period 1. The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.	3	62	25	62
EG005	Placebo to LY 90 mg Q2W (Week 16), Rescue Period	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1. 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 52-week Treatment Period 1. The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.	2	90	20	90
EG006	LY 120 mg Q4W, Treatment Period 2	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 52 weeks during Treatment Period 1. At Week 16, 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 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. At Week 52, 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 Treatment Period 2. Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	1	57	22	57
EG007	LY 90 mg Q2W, Treatment Period 2	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 52 weeks during Treatment Period 1. At Week 16, both Week 16 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 Treatment Period 1. At Week 52, both Week 16 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 Treatment Period 2. Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	1	73	20	73
EG008	Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	2	27	7	27
EG009	Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2 Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	1	31	4	31
EG010	LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2	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 during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. At Week 16, 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 52-week Treatment Period 1. During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399. Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	0	13	7	13
EG011	Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1. At Week 16, 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 52-week Treatment Period 1. During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399. Treatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.	0	22	9	22
EG012	LY 120 mg Q4W, 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 52 weeks during Treatment Period 1. At Week 16, 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 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. At Week 52, 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 Treatment Period 2. The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	9	241	43	241
EG013	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 52 weeks during Treatment Period 1. At Week 16, both Week 16 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 Treatment Period 1. At Week 52, both Week 16 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 Treatment Period 2. The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	14	303	39	303
EG014	Placebo to LY 120 mg Q4W (Week 52), Follow-up Period	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. At Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	1	27	6	27
EG015	Placebo to LY 90 mg Q2W (Week 52), Follow-up Period	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. At Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2 The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	1	27	9	27
EG016	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 during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. At Week 16, 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 52-week Treatment Period 1. During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399. The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	5	52	10	52
EG017	Placebo to LY 90 mg Q2W (Week 16), Follow-up Period	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1. At Week 16, 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 52-week Treatment Period 1. During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399. The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	4	85	10	85
EG018	Placebo, Follow-up Period	A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. The Post-Treatment Follow-Up Period started after Week 52 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.	14	168	26	168

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG0030 events0 affected58 at risk EG0040 events0 affected62 at risk EG0050 events0 affected90 at risk EG0060 events0 affected57 at risk EG0070 events0 affected73 at risk EG0080 events0 affected27 at risk EG0090 events0 affected31 at risk EG0100 events0 affected13 at risk EG0110 events0 affected22 at risk EG0120 events0 affected241 at risk EG0130 events0 affected303 at risk EG0140 events0 affected27 at risk EG0150 events0 affected27 at risk EG0160 events0 affected52 at risk EG0171 events1 affected85 at risk EG0180 events0 affected168 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Coronary artery insufficiency	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0022 events2 affected348 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Death	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Device dislocation	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Device related infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Infective tenosynovitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Peritonitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pyelonephritis chronic	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected345 at risk EG0020 events0 affected348 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0024 events4 affected348 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
B-cell lymphoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Bladder transitional cell carcinoma stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0011 events1 affected289 at risk EG0020 events0 affected291 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0011 events1 affected289 at risk EG0020 events0 affected291 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Cerebral atrophy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Presyncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Radiculitis lumbosacral	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Stress	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0008 events8 affected345 at risk EG0016 events6 affected345 at risk EG00211 events11 affected348 at risk EG0031 events1 affected58 at risk EG0040 events0 affected62 at risk EG0055 events5 affected90 at risk EG0060 events0 affected57 at risk EG0070 events0 affected73 at risk EG0081 events1 affected27 at risk EG0090 events0 affected31 at risk EG0100 events0 affected13 at risk EG0110 events0 affected22 at risk EG0121 events1 affected241 at risk EG0131 events1 affected303 at risk EG0140 events0 affected27 at risk EG0150 events0 affected27 at risk EG0160 events0 affected52 at risk EG0170 events0 affected85 at risk EG0180 events0 affected168 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0006 events5 affected345 at risk EG0012 events1 affected345 at risk EG0022 events2 affected348 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cataract	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0012 events2 affected345 at risk EG0021 events1 affected348 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0012 events2 affected345 at risk EG0021 events1 affected348 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected345 at risk EG0013 events3 affected345 at risk EG0026 events6 affected348 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected345 at risk EG0019 events9 affected345 at risk EG0026 events5 affected348 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected345 at risk EG0022 events2 affected348 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected345 at risk EG0025 events5 affected348 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected345 at risk EG00111 events7 affected345 at risk EG0023 events3 affected348 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 events3 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Injection site erythema	General disorders	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected345 at risk EG0015 events4 affected345 at risk EG0021 events1 affected348 at risk EG003
Malaise	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0022 events2 affected348 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected345 at risk EG0023 events3 affected348 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0013 events3 affected345 at risk EG0021 events1 affected348 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected345 at risk EG0022 events2 affected348 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0008 events8 affected345 at risk EG0018 events8 affected345 at risk EG00211 events11 affected348 at risk EG003
Candidiasis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Cystitis bacterial	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0012 events2 affected345 at risk EG0022 events2 affected348 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0012 events2 affected345 at risk EG0028 events8 affected348 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00025 events20 affected345 at risk EG00122 events15 affected345 at risk EG00234 events25 affected348 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected345 at risk EG0014 events4 affected345 at risk EG0025 events5 affected348 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00021 events18 affected345 at risk EG00121 events20 affected345 at risk EG00220 events18 affected348 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00012 events10 affected345 at risk EG0018 events6 affected345 at risk EG0026 events5 affected348 at risk EG003
Viral infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0022 events2 affected348 at risk EG003
Vulvovaginitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected345 at risk EG0024 events4 affected348 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected345 at risk EG0022 events2 affected348 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected345 at risk EG0012 events2 affected345 at risk EG0026 events6 affected348 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Blood glucose increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Blood potassium decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0012 events2 affected345 at risk EG0021 events1 affected348 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Liver function test abnormal	Investigations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
White blood cell count decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0009 events6 affected345 at risk EG00110 events9 affected345 at risk EG0027 events7 affected348 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00010 events10 affected345 at risk EG0016 events6 affected345 at risk EG0025 events5 affected348 at risk EG003
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected345 at risk EG0011 events1 affected345 at risk EG0023 events3 affected348 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00014 events12 affected345 at risk EG00120 events19 affected345 at risk EG00218 events15 affected348 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0011 events1 affected345 at risk EG0020 events0 affected348 at risk EG003
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected294 at risk EG0011 events1 affected289 at risk EG0020 events0 affected291 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0010 events0 affected345 at risk EG0023 events2 affected348 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected345 at risk EG0016 events6 affected345 at risk EG0025 events5 affected348 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00010 events7 affected345 at risk EG0016 events6 affected345 at risk EG0023 events3 affected348 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0022 events2 affected348 at risk EG003
Migraine	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0012 events2 affected345 at risk EG0020 events0 affected348 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0010 events0 affected345 at risk EG0021 events1 affected348 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected345 at risk EG0011 events1 affected345 at risk EG0021 events1 affected348 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected345 at risk EG0013 events3 affected345 at risk EG0023 events3 affected348 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected56 at risk EG0020 events0 affected57 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected294 at risk EG0010 events0 affected289 at risk EG0020 events0 affected291 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0008 events7 affected345 at risk EG0013 events3 affected345 at risk EG0025 events5 affected348 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0013 events3 affected345 at risk EG0021 events1 affected348 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected345 at risk EG0013 events3 affected345 at risk EG0026 events5 affected348 at risk EG003
Haematoma	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected345 at risk EG0010 events0 affected345 at risk EG0020 events0 affected348 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG00013 events12 affected345 at risk EG0013 events3 affected345 at risk EG0027 events7 affected348 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected345 at risk EG0012 events2 affected345 at risk EG0020 events0 affected348 at risk EG003

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

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	120 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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 blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.
BG001	90 mg LY2127399	Treatment Period 1 (Weeks 0-52): 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. 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 Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, 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 Treatment Period 2. 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 100-week treatment period.
BG002	Placebo	Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. 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 100-week treatment period.
BG003	Total	Total of all reporting groups