An Open Label Study for Participants With Rheumatoid Arth... | NCT01215942

NCT01215942

ID	Type	Description	Link
H9B-MC-BCDP	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
120 milligrams (mg) of LY2127399	Experimental	Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment. Or Given every 4 weeks for 168 weeks for those participants from Study BCDM.	Drug: LY2127399
90 mg LY2127399	Experimental	Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment. Or Given every 2 weeks for 168 weeks for those participants from Study BCDM.	Drug: LY2127399

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period	A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.	up to 84.4 weeks during treatment period
Percentage of Participants Developing Anti-LY2127399 Antibodies	Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.	Baseline through Weeks 4, 24, 48 and 72
Change From Baseline in Absolute B Cell Counts	Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)	ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: 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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.

Other Outcomes

Measure	Description	Time Frame
Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period		Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period

Eligibility Module

Contacts/Locations Module

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

Locations

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

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	120 mg LY2127399 (LY A)	120 milligrams (mg) LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study H9B-MC-BCDP (BCDP) enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000414 subjectsParticipants who discontinued treatment were followed in post-treatment follow-up.

FG001672 subjectsParticipants who discontinued treatment were followed in post-treatment follow-up.

All enrolled participants.

Arm/Group Information

ID	Title	Description
BG000	120 mg LY2127399 (LY A)	120 mg LY2127399 administered SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
BG001	90 mg LY2127399 (LY B)	90 mg LY2127399 administered SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.9± 10.9 BG00152.4± 11.7 BG00252.6± 11.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000339 BG001538 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00052 BG001100 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00017 BG00136 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000148 BG001294 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period

A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

All enrolled participants.

Posted

Count of Participants

Participants

up to 84.4 weeks during treatment period

ID	Title	Description
OG000	120 mg LY2127399 (LY A)	120 mg LY2127399 administered SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
OG001	90 mg LY2127399 (LY B)	90 mg LY2127399 administered SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.

Units	Counts
Participants	OG000414 OG001672

Title

Denominators

Categories

TEAE

Title	Measurements
	OG000259 OG001422

SAE

Title	Measurements
	OG000

Primary

Percentage of Participants Developing Anti-LY2127399 Antibodies

Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.

All participants from Studies BCDO and BCDV with an evaluable baseline anti-LY2127399 antibodies result and a post-baseline anti-LY2127399 antibodies result. Participants missing an evaluable baseline result with a negative post-baseline results were included.

Posted

Number

percentage of participants

Baseline through Weeks 4, 24, 48 and 72

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.

Primary

Change From Baseline in Absolute B Cell Counts

Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.

All participants from Studies BCDO and BCDV with an evaluable CD3-CD20+ B cell counts. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

Posted

Mean

Standard Deviation

cells/microliter (cells/µL)

Baseline, Week 48

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B

Secondary

Percentage of Participants With American College of Rheumatology 20% Response (ACR20)

ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: 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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.

All participants from Studies BCDO and BCDV with an evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR20 was missing after carrying forward CRP, last post-baseline ACR20 response was used.

Posted

Number

percentage of participants

Baseline through Weeks 12, 24 and 48

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B

Secondary

Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)

Zero participants analyzed. DAS28-CRP data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response

Zero participants analyzed. EULAR-28 data was not collected for analysis due to early termination of the study.

Posted

Baseline through 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores

Zero participants analyzed. SF-36 data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Tender Joint Count (68 Joint Count)

Zero participants analyzed. Tender joint count data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Swollen Joint Count (66 Joint Count)

Zero participants analyzed. Swollen joint count data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]

Zero participants analyzed. VAS data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Participants Global Assessment of Disease Activity (VAS)

Zero participants analyzed. Participants Global assessment data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)

Zero participants analyzed. Physicians global assessment data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Zero participants analyzed. HAQ-DI data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

Change From Baseline in CRP

Zero participants analyzed. CRP data was not collected for analysis due to early termination of the study.

Posted

Baseline, 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Secondary

American College of Rheumatology Percent Improvement (ACR-N)

Zero participants analyzed. ACR-N data was not collected for analysis due to early termination of the study.

Posted

Baseline through 240 weeks

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
OG003	NR LY B to LY B	90 mg LY2127399 administered SC Q2W. All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

Other Pre-specified

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

All enrolled participants.

Posted

Count of Participants

Participants

Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period

ID	Title	Description
OG000	120 mg LY2127399 (LY A)	120 mg LY2127399 administered SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
OG001	90 mg LY2127399 (LY B)	90 mg LY2127399 administered SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.

Primary

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 A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.

All participants from Studies BCDO and BCDV with an evaluable serum Ig data. LOCF was used to impute missing post-baseline values.

Posted

Mean

Standard Deviation

grams/liter (g/L)

Baseline, Week 48

ID	Title	Description
OG000	LY A	120 mg LY2127399 administered SC Q4W (LY A). All Week 16 responders from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV.
OG001	LY B	90 mg LY2127399 administered SC Q2W (LY B). All Week 16 responders from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV.
OG002	NR LY A to LY B

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	120 mg LY2127399 (LY A) Treatment Period	120 mg LY2127399 administered SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.	30	414	130	414
EG001	90 mg LY2127399 (LY B) Treatment Period	90 mg LY2127399 administered SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.	57	672	251	672
EG002	120 mg LY2127399 (LY A) Follow-Up Period	The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment. Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 120 mg LY2127399 SC Q4W during Study BCDP treatment period.	15	368	47	368
EG003	90 mg LY2127399 (LY B) Follow-Up Period	The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment. Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 90 mg LY2127399 SC Q2W during Study BCDP treatment period.	28	591	71	591

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 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG0030 events0 affected591 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0012 events2 affected672 at risk EG0020 events0 affected368 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Diabetic retinal oedema	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Maculopathy	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Colon dysplasia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0012 events2 affected672 at risk EG0020 events0 affected368 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0012 events2 affected672 at risk EG0020 events0 affected368 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Abscess limb	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Infected bunion	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0010 events0 affected538 at risk EG0020 events0 affected301 at risk EG003
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0011 events1 affected672 at risk EG0021 events1 affected368 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Septic shock	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0012 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Urosepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Wound infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0012 events2 affected672 at risk EG0021 events1 affected368 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0012 events2 affected672 at risk EG0021 events1 affected368 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected414 at risk EG0015 events5 affected672 at risk EG0022 events2 affected368 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0013 events2 affected672 at risk EG0021 events1 affected368 at risk EG003
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0011 events1 affected538 at risk EG0020 events0 affected301 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected134 at risk EG0020 events0 affected67 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0010 events0 affected538 at risk EG0020 events0 affected301 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Vertebral artery dissection	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0011 events1 affected538 at risk EG0020 events0 affected301 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0011 events1 affected538 at risk EG0020 events0 affected301 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Schizoaffective disorder bipolar type	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected339 at risk EG0011 events1 affected538 at risk EG0020 events0 affected301 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0012 events2 affected672 at risk EG0020 events0 affected368 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Arterial haemorrhage	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0020 events0 affected368 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected414 at risk EG0010 events0 affected672 at risk EG0021 events1 affected368 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected414 at risk EG0011 events1 affected672 at risk EG0020 events0 affected368 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	EG0006 events6 affected414 at risk EG00115 events15 affected672 at risk EG0023 events3 affected368 at risk EG0034 events4 affected591 at risk
Injection site reaction	General disorders	MedDRA 16.0	Systematic Assessment	EG00010 events7 affected414 at risk EG00144 events16 affected672 at risk EG0020 events0 affected368 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00015 events15 affected414 at risk EG00136 events30 affected672 at risk EG0027 events5 affected368 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected414 at risk EG00119 events18 affected672 at risk EG0023 events3 affected368 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00032 events21 affected414 at risk EG00144 events38 affected672 at risk EG00217 events12 affected368 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00019 events17 affected414 at risk EG00126 events23 affected672 at risk EG0023 events3 affected368 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00036 events23 affected414 at risk EG00189 events73 affected672 at risk EG0028 events8 affected368 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00019 events16 affected414 at risk EG00122 events17 affected672 at risk EG0022 events2 affected368 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00019 events16 affected414 at risk EG00127 events25 affected672 at risk EG0023 events3 affected368 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0009 events9 affected414 at risk EG0017 events6 affected672 at risk EG0022 events2 affected368 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00033 events26 affected414 at risk EG00165 events59 affected672 at risk EG00210 events10 affected368 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00011 events11 affected414 at risk EG00111 events9 affected672 at risk EG0021 events1 affected368 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00011 events10 affected414 at risk EG00114 events13 affected672 at risk EG0020 events0 affected368 at risk EG003

Study BCDP was terminated early due to insufficient efficacy observed in Studies BCDM and BCDV. 4 participants enrolled from Study BCDM were included in TEAE, SAE, AESI and death summary but not in summary of other primary or secondary measures.

Certain Agreements

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C575974	tabalumab

90 mg LY2127399 administered SC Q2W.

All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.

90 mg LY2127399 administered SC Q2W.

All Week 16 NR from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.