A Safety and Pharmacokinetics Study in Participants With... | NCT00380744

NCT00380744

ID	Type	Description	Link
H9C-MC-BBDE	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
Part A LY2189102 0.1 mg/kg/wk	Experimental	Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV	Drug: LY2189102
Part A LY2189102 0.3 mg/kg/wk	Experimental	Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV	Drug: LY2189102
Part A LY2189102 1.0 mg/kg/wk	Experimental	Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV	Drug: LY2189102
Part A LY2189102 2.5 mg/kg/wk	Experimental	Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV	Drug: LY2189102
Placebo	Placebo Comparator	IV, once weekly x 4 wks	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
LY2189102	Drug		Part A LY2189102 0.1 mg/kg/wk Part A LY2189102 0.3 mg/kg/wk Part A LY2189102 1.0 mg/kg/wk Part A LY2189102 2.5 mg/kg/wk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.	Baseline up to Day 98

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102	AUC0-168 hr,ss of individual participants was calculated by equation AUC=Dose/Clearance (CL), where the CL was estimated using a population PK model. Time frame for Part B: Day 1 predose, immediately after infusion (IAI), Day 14 and 28: predose and IAI, and Day 63 (Convenient time);

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 (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Tucson	Arizona	85712

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24912797	Derived	Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.

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	Part B - 0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 milligrams/kilogram/week (mg/kg/wk) of LY2189102, followed by 0.02 mg/kg/wk for 4 weeks (wks), intravenously (IV).
FG001	Part A - 0.1 mg/kg/wk LY2189102

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

All randomized participants who received at least 1 dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Part B - 0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
BG001	Part A - 0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
BG002	Part B - 0.15 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
BG003	Part A - 0.3 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
BG004	All Parts - 1.0 mg/kg/wk LY2189102	Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
BG005	All Parts - 2.5 mg/kg/wk LY2189102	Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
BG006	All Parts - Placebo	Participants were administered matched placebo IV, once weekly for 4 wks.
BG007	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG0014 BG00220 BG0034 BG00423 BG00525 BG00625 BG007121

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
	BG00053.9± 10.1 BG00152.5± 8.0 BG00250.2± 14.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

African

Title	Measurements
	BG0002 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0004 BG0014 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 With Adverse Events (AEs)

Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Count of Participants

Participants

Baseline up to Day 98

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
OG002	0.15 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
OG003	0.3 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
OG004	1.0 mg/kg/wk LY2189102	Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
OG005	2.5 mg/kg/wk LY2189102	Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
OG006	Placebo	Participants were administered matched placebo IV, once weekly for 4 wks.

Units	Counts
Participants	OG00020 OG0014 OG00220 OG003

Title

Denominators

Categories

SAEs

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102

AUC0-168 hr,ss of individual participants was calculated by equation AUC=Dose/Clearance (CL), where the CL was estimated using a population PK model.

Time frame for Part B: Day 1 predose, immediately after infusion (IAI), Day 14 and 28: predose and IAI, and Day 63 (Convenient time);

All participants who received at least 1 dose of study drug in part A & B and had evaluable AUC0-168 hr,ss results.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms*hour/milliliter (µg*h/mL)

Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
OG002	0.15 mg/kg/wk LY2189102

Secondary

Change From Baseline in Simple Disease Activity Index Score (SDAI)

SDAI is calculated as the sum of 5 components: tender joint count (TJC) and swollen joint count (SJC), Patient Global Assessment (PtGA) of disease activity visual analog scale (VAS) and Physician's Global Assessment of Disease Activity (PGA) VAS, and C-reactive protein (CRP). Total Score scale range is 0 (remission) to 86 (high disease activity). A negative change from baseline indicated an improvement. Least Squares (LS) mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.

All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Days 7, 21, 35, 63, and 98

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
OG002	0.15 mg/kg/wk LY2189102

Secondary

Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)

DAS28-4 (crp) is a modification of the original DAS based on TJC and SJC based on 28 joint counts, PGA VAS. DAS28-4 (crp) calculated as: 0.56*square root (sqrt) (TJC)+0.28*sqrt(SJC)+0.36*ln(CRP+1)+0.014*PGA+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. A decrease in DAS28-CRP indicated an improvement in participant's condition.

LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.

All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Days 7, 21, 35, 63, and 98

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
OG002	0.15 mg/kg/wk LY2189102

Secondary

Change From Baseline in C-Reactive Protein (CRP)

CRP is a biomarker associated with inflammation and structural damage. A negative change from baseline indicates improvement. LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.

All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Least Squares Mean

95% Confidence Interval

milligrams/deciliter (mg/dL)

Baseline, Days 7, 14, 21, 28, 35, 63, and 98

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
OG002	0.15 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
OG003

Secondary

Change From Baseline in Health Assessment Questionnaire (HAQ) Score

HAQ was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ score. If the participant had scores for fewer than 6 categories, the HAQ score was considered missing. The HAQ score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.

All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

Per protocol analysis was performed per dose irrespective of study parts.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Days 35, 63, and 98

ID	Title	Description
OG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
OG001	0.1 mg/kg/wk LY2189102

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.02 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.	0	20	8	20
EG001	0.1 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.	0	4	4	4
EG002	0.15 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.	0	20	10	20
EG003	0.3 mg/kg/wk LY2189102	Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.	0	4	4	4
EG004	1.0 mg/kg/wk LY2189102	Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.	0	23	7	23
EG005	2.5 mg/kg/wk LY2189102	Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.	1	25	11	25
EG006	Placebo	Participants were administered matched placebo IV, once weekly for 4 wks.	2	25	14	25

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG0030 events0 affected4 at risk EG0040 events0 affected23 at risk EG0050 events0 affected25 at risk EG0061 events1 affected25 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Influenza	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Hypertension	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG0030 events0 affected4 at risk EG0040 events0 affected23 at risk EG0050 events0 affected25 at risk EG0061 events1 affected25 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Nodal arrhythmia	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Palpitations	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Glaucoma	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Keratitis	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected4 at risk EG0020 events0 affected20 at risk EG003
Tooth loss	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Asthenia	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Chills	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Cyst	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Fatigue	General disorders	MedDRA 8.0	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Infusion site erythema	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0022 events1 affected20 at risk EG003
Infusion site haematoma	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Infusion site reaction	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Injection site inflammation	General disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Vessel puncture site haematoma	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Bronchitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Cellulitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Influenza	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Localised infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Oral herpes	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Rhinitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Sinusitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected4 at risk EG0020 events0 affected20 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Blood potassium decreased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Blood pressure increased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Blood urine present	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Body temperature increased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0022 events1 affected20 at risk EG003
Platelet count decreased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
White blood cell count decreased	Investigations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Hypocholesterolaemia	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dizziness	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Headache	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0023 events2 affected20 at risk EG003
Migraine	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Post-traumatic headache	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Depression	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected4 at risk EG0020 events0 affected20 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dyspareunia	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0010 events0 affected2 at risk EG0021 events1 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected4 at risk EG0020 events0 affected20 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0021 events1 affected20 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003
Hypertension	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected4 at risk EG0020 events0 affected20 at risk EG003

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
C586827	LY2189102

Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.