Trial Outcomes & Findings for A Study in Patients With Rheumatoid Arthritis (NCT NCT00966875)

Last Updated: 2016-05-26

Results Overview

ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) \* 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

448 participants

Primary outcome timeframe

Week 12

Results posted on

2016-05-26

Participant Flow

Participants were randomized to Part A and had the option of continuing in the open-label extension, Part B after completing Part A.

Participant milestones

Participant milestones
Measure	Placebo [bDMARD-naive Population] Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\]	3 mg LY2439821 [bDMARD-naive Population] 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg LY2439821 [bDMARD-naive Population] 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg LY2439821 [bDMARD-naive Population] 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 [bDMARD-naive Population] 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821[bDMARD-naive Population] 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo [TNFα-IR Population] Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\]	80 mg LY2439821 [TNFα-IR Population] 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821 [TNFα-IR Population] 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Part A STARTED	54	40	35	37	57	37	64	65	59
Part A Received ≥1 Doses of Study Drug	54	40	35	37	57	37	64	65	59
Part A COMPLETED	48	36	33	34	52	33	52	58	51
Part A NOT COMPLETED	6	4	2	3	5	4	12	7	8
Part B STARTED	46	36	33	34	51	32	51	57	50
Part B COMPLETED	41	33	27	31	44	26	29	38	32
Part B NOT COMPLETED	5	3	6	3	7	6	22	19	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo [bDMARD-naive Population] Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\]	3 mg LY2439821 [bDMARD-naive Population] 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg LY2439821 [bDMARD-naive Population] 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg LY2439821 [bDMARD-naive Population] 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 [bDMARD-naive Population] 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821[bDMARD-naive Population] 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo [TNFα-IR Population] Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\]	80 mg LY2439821 [TNFα-IR Population] 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821 [TNFα-IR Population] 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Part A Adverse Event	2	1	0	1	0	1	0	3	3
Part A Entry Criteria	0	0	0	0	0	2	0	0	0
Part A Lack of Efficacy	0	1	0	0	0	0	4	0	0
Part A Lost to Follow-up	2	0	0	0	0	1	0	0	0
Part A Parent/Caregiver Decision	0	0	0	1	0	0	0	0	0
Part A Physician Decision	0	0	0	0	1	0	1	0	2
Part A Sponsor Decision	0	0	1	0	1	0	0	2	1
Part A Withdrawal by Subject	2	2	1	1	3	0	5	1	1
Part A Protocol Violation	0	0	0	0	0	0	2	1	1
Part B Adverse Event	0	1	1	0	1	0	5	2	2
Part B Death	0	0	1	0	0	0	0	1	0
Part B Lack of Efficacy	2	1	1	1	2	3	12	9	6
Part B Lost to Follow-up	0	0	0	1	0	0	0	0	1
Part B Physician Decision	0	0	1	0	2	1	0	0	2
Part B Sponsor Decision	1	0	0	0	0	1	0	2	1
Part B Withdrawal by Subject	2	1	2	1	2	1	4	5	5
Part B Entry Criteria	0	0	0	0	0	0	1	0	1

Baseline Characteristics

A Study in Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo [bDMARD-naive Population] n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	3 mg LY2439821 [bDMARD-naive Population] n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg LY2439821 [bDMARD-naive Population] n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg LY2439821 [bDMARD-naive Population n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 [bDMARD-naive Population] n=57 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821[bDMARD-naive Population] n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo [TNFα-IR Population] n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 [TNFα-IR Population] n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821 [TNFα-IR Population] n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Total n=448 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	37 Participants n=7 Participants	30 Participants n=5 Participants	29 Participants n=4 Participants	48 Participants n=21 Participants	32 Participants n=8 Participants	59 Participants n=8 Participants	55 Participants n=24 Participants	52 Participants n=42 Participants	387 Participants n=42 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	10 Participants n=24 Participants	7 Participants n=42 Participants	61 Participants n=42 Participants
Age, Continuous	52.99 years STANDARD_DEVIATION 10.18 • n=5 Participants	52.19 years STANDARD_DEVIATION 9.67 • n=7 Participants	53.86 years STANDARD_DEVIATION 10.62 • n=5 Participants	53.03 years STANDARD_DEVIATION 12.16 • n=4 Participants	52.60 years STANDARD_DEVIATION 10.91 • n=21 Participants	52.21 years STANDARD_DEVIATION 11.33 • n=8 Participants	53.19 years STANDARD_DEVIATION 10.44 • n=8 Participants	54.74 years STANDARD_DEVIATION 11.12 • n=24 Participants	52.43 years STANDARD_DEVIATION 9.90 • n=42 Participants	53.08 years STANDARD_DEVIATION 10.61 • n=42 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	33 Participants n=7 Participants	27 Participants n=5 Participants	31 Participants n=4 Participants	52 Participants n=21 Participants	30 Participants n=8 Participants	55 Participants n=8 Participants	57 Participants n=24 Participants	51 Participants n=42 Participants	383 Participants n=42 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	9 Participants n=8 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	65 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	15 Participants n=8 Participants	23 Participants n=24 Participants	15 Participants n=42 Participants	100 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	32 Participants n=7 Participants	24 Participants n=5 Participants	29 Participants n=4 Participants	46 Participants n=21 Participants	30 Participants n=8 Participants	48 Participants n=8 Participants	41 Participants n=24 Participants	43 Participants n=42 Participants	338 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	10 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	16 Participants n=42 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	17 Participants n=21 Participants	10 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	88 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	23 Participants n=42 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	31 Participants n=21 Participants	22 Participants n=8 Participants	54 Participants n=8 Participants	58 Participants n=24 Participants	50 Participants n=42 Participants	305 Participants n=42 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	16 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United States	12 participants n=5 Participants	9 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	12 participants n=21 Participants	9 participants n=8 Participants	33 participants n=8 Participants	32 participants n=24 Participants	31 participants n=42 Participants	154 participants n=42 Participants
Region of Enrollment Taiwan	5 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	3 participants n=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants	1 participants n=42 Participants	26 participants n=42 Participants
Region of Enrollment Argentina	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	10 participants n=8 Participants	11 participants n=24 Participants	10 participants n=42 Participants	34 participants n=42 Participants
Region of Enrollment Poland	11 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	7 participants n=4 Participants	9 participants n=21 Participants	7 participants n=8 Participants	11 participants n=8 Participants	11 participants n=24 Participants	10 participants n=42 Participants	82 participants n=42 Participants
Region of Enrollment Romania	5 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	3 participants n=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants	0 participants n=42 Participants	27 participants n=42 Participants
Region of Enrollment Peru	6 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	4 participants n=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants	1 participants n=42 Participants	31 participants n=42 Participants
Region of Enrollment Chile	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	1 participants n=8 Participants	2 participants n=24 Participants	1 participants n=42 Participants	11 participants n=42 Participants
Region of Enrollment Russian Federation	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants	2 participants n=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants	1 participants n=42 Participants	13 participants n=42 Participants
Region of Enrollment Germany	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	3 participants n=8 Participants	2 participants n=24 Participants	2 participants n=42 Participants	8 participants n=42 Participants
Region of Enrollment Korea, Republic of	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	1 participants n=8 Participants	2 participants n=8 Participants	3 participants n=24 Participants	2 participants n=42 Participants	16 participants n=42 Participants
Region of Enrollment India	9 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	11 participants n=21 Participants	6 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	46 participants n=42 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=57 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population	34.1 percentage of participants	46.2 percentage of participants	52.2 percentage of participants	55.0 percentage of participants	55.3 percentage of participants	54.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.

ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) \* 100.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=65 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=59 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population	23.4 percentage of participants	40.0 percentage of participants	39.0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.

ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=206 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population Estimated dose to achieve 10% response	0.8 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population Estimated dose to achieve 50% response	2.4 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population Estimated dose to achieve 90% response	13.8 log (dose) mg	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.

DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP \[milligrams per liter (mg/L)\], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 - CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln\[CRP +1\]) + 0.014(VAS) + 0.96.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=206 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population Estimated dose to achieve 10% response	7.3 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population Estimated dose to achieve 50 % response	41.5 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population Estimated dose to achieve 90% response	97.0 log (dose) mg	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.

ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=206 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population Estimated dose to achieve 10% response	7.3 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population Estimated dose to achieve 50% response	37.9 log (dose) mg	—	—	—	—	—	—	—	—
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population Estimated dose to achieve 90% response	81.2 log (dose) mg	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).

DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln\[CRP +1\]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=57 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Disease Activity Score (DAS28)-Part A	-0.818 units on a scale Standard Deviation 0.981	-1.308 units on a scale Standard Deviation 1.092	-1.565 units on a scale Standard Deviation 1.440	-1.671 units on a scale Standard Deviation 1.193	-1.686 units on a scale Standard Deviation 1.344	-1.940 units on a scale Standard Deviation 1.152	-0.619 units on a scale Standard Deviation 1.109	-1.310 units on a scale Standard Deviation 1.303	-1.571 units on a scale Standard Deviation 1.261

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=33 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in DAS28 - Part B	-2.143 units on a scale Standard Deviation 1.177	-1.832 units on a scale Standard Deviation 1.031	-2.320 units on a scale Standard Deviation 1.292	-2.277 units on a scale Standard Deviation 1.337	-2.280 units on a scale Standard Deviation 1.316	-2.475 units on a scale Standard Deviation 1.140	-1.740 units on a scale Standard Deviation 1.460	-1.604 units on a scale Standard Deviation 1.282	-1.874 units on a scale Standard Deviation 1.279

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug.

ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 \[or ACR50 or ACR70\] responders per treatment arm) / (total number of participants per treatment arm) \* 100.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=57 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants With ACR20/50/70 Response - Part A ACR20	35.2 percentage of participants	45.0 percentage of participants	42.9 percentage of participants	70.3 percentage of participants	50.9 percentage of participants	54.1 percentage of participants	23.4 percentage of participants	40.0 percentage of participants	39.0 percentage of participants
Percentage of Participants With ACR20/50/70 Response - Part A ACR50	9.3 percentage of participants	17.5 percentage of participants	28.6 percentage of participants	29.7 percentage of participants	26.3 percentage of participants	27.0 percentage of participants	7.8 percentage of participants	20.0 percentage of participants	16.9 percentage of participants
Percentage of Participants With ACR20/50/70 Response - Part A ACR70	1.9 percentage of participants	5.0 percentage of participants	14.3 percentage of participants	13.5 percentage of participants	7.0 percentage of participants	13.5 percentage of participants	3.1 percentage of participants	3.1 percentage of participants	10.2 percentage of participants

SECONDARY outcome

Timeframe: Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.

ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 \[or ACR50 or ACR70\] responders per treatment arm) / (total number of participants per treatment arm) \* 100\].

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=40 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=32 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants With of ACR20/50/70 Response - Part B ACR20	75.0 percentage of participants	65.6 percentage of participants	67.9 percentage of participants	80.6 percentage of participants	72.7 percentage of participants	80.8 percentage of participants	51.6 percentage of participants	43.9 percentage of participants	64.7 percentage of participants
Percentage of Participants With of ACR20/50/70 Response - Part B ACR50	42.5 percentage of participants	37.5 percentage of participants	50.0 percentage of participants	48.4 percentage of participants	47.7 percentage of participants	61.5 percentage of participants	32.3 percentage of participants	22.0 percentage of participants	38.2 percentage of participants
Percentage of Participants With of ACR20/50/70 Response - Part B ACR70	17.5 percentage of participants	12.5 percentage of participants	32.1 percentage of participants	22.6 percentage of participants	11.4 percentage of participants	30.8 percentage of participants	19.4 percentage of participants	9.8 percentage of participants	17.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A	-2.95 tender joints Standard Deviation 5.20	-6.02 tender joints Standard Deviation 7.35	-6.79 tender joints Standard Deviation 7.67	-7.05 tender joints Standard Deviation 6.28	-7.66 tender joints Standard Deviation 8.96	-8.96 tender joints Standard Deviation 7.47	-2.96 tender joints Standard Deviation 6.31	-6.02 tender joints Standard Deviation 7.31	-6.02 tender joints Standard Deviation 6.74

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B	-8.73 tender joints Standard Deviation 6.85	-8.78 tender joints Standard Deviation 5.32	-11.43 tender joints Standard Deviation 6.54	-9.55 tender joints Standard Deviation 6.20	-10.86 tender joints Standard Deviation 7.48	-10.55 tender joints Standard Deviation 7.11	-6.62 tender joints Standard Deviation 8.39	-7.35 tender joints Standard Deviation 6.83	-6.81 tender joints Standard Deviation 6.11

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A	-2.69 swollen joints Standard Deviation 6.07	-4.25 swollen joints Standard Deviation 5.58	-6.51 swollen joints Standard Deviation 7.65	-6.16 swollen joints Standard Deviation 6.44	-7.49 swollen joints Standard Deviation 7.98	-6.52 swollen joints Standard Deviation 6.62	-1.69 swollen joints Standard Deviation 5.93	-5.57 swollen joints Standard Deviation 5.51	-5.15 swollen joints Standard Deviation 5.65

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.

SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B	-7.25 swollen joints Standard Deviation 6.15	-5.73 swollen joints Standard Deviation 4.95	-9.06 swollen joints Standard Deviation 5.92	-7.26 swollen joints Standard Deviation 5.73	-8.95 swollen joints Standard Deviation 6.64	-8.96 swollen joints Standard Deviation 6.06	-7.32 swollen joints Standard Deviation 6.45	-5.46 swollen joints Standard Deviation 6.51	-6.29 swollen joints Standard Deviation 5.75

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain." The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=63 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=56 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A	-14.8 mm Standard Deviation 23.7	-18.7 mm Standard Deviation 22.8	-21.3 mm Standard Deviation 28.4	-29.8 mm Standard Deviation 24.1	-25.8 mm Standard Deviation 23.0	-25.3 mm Standard Deviation 27.5	-9.4 mm Standard Deviation 24.0	-10.3 mm Standard Deviation 24.7	-18.8 mm Standard Deviation 26.6

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.

Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain". The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B	-32.5 mm Standard Deviation 27.8	-26.2 mm Standard Deviation 20.3	-33.3 mm Standard Deviation 33.4	-36.2 mm Standard Deviation 27.4	-32.4 mm Standard Deviation 22.6	-41.2 mm Standard Deviation 23.0	-25.5 mm Standard Deviation 22.3	-16.5 mm Standard Deviation 21.1	-26.2 mm Standard Deviation 26.2

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=63 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=58 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A	-19.2 mm Standard Deviation 21.4	-17.3 mm Standard Deviation 20.9	-18.5 mm Standard Deviation 28.7	-29.1 mm Standard Deviation 23.1	-22.1 mm Standard Deviation 23.7	-30.1 mm Standard Deviation 26.9	-10.1 mm Standard Deviation 24.7	-12.1 mm Standard Deviation 27.9	-21.6 mm Standard Deviation 25.4

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=32 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=33 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B	-35.4 mm Standard Deviation 26.2	-24.9 mm Standard Deviation 25.4	-31.8 mm Standard Deviation 30.4	-34.8 mm Standard Deviation 27.0	-28.5 mm Standard Deviation 24.7	-39.8 mm Standard Deviation 25.5	-22.4 mm Standard Deviation 23.2	-17.8 mm Standard Deviation 21.4	-25.1 mm Standard Deviation 23.9

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A	-16.0 mm Standard Deviation 19.0	-21.0 mm Standard Deviation 15.6	-21.7 mm Standard Deviation 25.2	-26.7 mm Standard Deviation 18.1	-24.5 mm Standard Deviation 22.3	-28.8 mm Standard Deviation 24.2	-8.6 mm Standard Deviation 21.4	-25.7 mm Standard Deviation 22.2	-22.0 mm Standard Deviation 24.0

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.

The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B	-36.1 mm Standard Deviation 21.7	-30.1 mm Standard Deviation 22.0	-38.5 mm Standard Deviation 28.4	-38.0 mm Standard Deviation 18.5	-31.0 mm Standard Deviation 20.7	-44.4 mm Standard Deviation 17.7	-30.1 mm Standard Deviation 22.5	-28.9 mm Standard Deviation 25.8	-32.7 mm Standard Deviation 25.2

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A	-1.575 mg/L Standard Deviation 22.336	-6.079 mg/L Standard Deviation 10.289	-9.435 mg/L Standard Deviation 23.148	-7.999 mg/L Standard Deviation 14.740	-11.968 mg/L Standard Deviation 19.792	-13.575 mg/L Standard Deviation 25.692	1.229 mg/L Standard Deviation 14.811	-9.521 mg/L Standard Deviation 20.312	-8.297 mg/L Standard Deviation 21.955

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.

CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=30 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=40 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B	-10.548 mg/L Standard Deviation 18.555	-4.556 mg/L Standard Deviation 12.937	-11.340 mg/L Standard Deviation 23.347	-7.865 mg/L Standard Deviation 22.607	-14.519 mg/L Standard Deviation 19.260	-6.860 mg/L Standard Deviation 16.745	-12.094 mg/L Standard Deviation 28.917	-10.130 mg/L Standard Deviation 18.030	-9.004 mg/L Standard Deviation 19.698

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) \* 100.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=63 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=58 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A	44.4 percentage of participants	67.5 percentage of participants	60.0 percentage of participants	75.7 percentage of participants	73.2 percentage of participants	75.7 percentage of participants	36.5 percentage of participants	60.0 percentage of participants	65.5 percentage of participants

SECONDARY outcome

Timeframe: Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.

Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) \* 100.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=33 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants in EULAR28 - Part B	90.2 percentage of participants	81.8 percentage of participants	82.1 percentage of participants	83.9 percentage of participants	84.1 percentage of participants	88.5 percentage of participants	64.5 percentage of participants	73.2 percentage of participants	69.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.

ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: \[(post baseline value - baseline value) / baseline value\] \* 100.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=47 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=36 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=34 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=36 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=54 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=35 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=56 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=60 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=54 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
ACR-N - Part A	-11.034 units on a scale Standard Deviation 104.809	-0.699 units on a scale Standard Deviation 139786	15.162 units on a scale Standard Deviation 51.130	11.137 units on a scale Standard Deviation 128.516	18.351 units on a scale Standard Deviation 41.493	23.375 units on a scale Standard Deviation 42.173	-7.356 units on a scale Standard Deviation 45.724	2.264 units on a scale Standard Deviation 59.277	11.541 units on a scale Standard Deviation 49.358

SECONDARY outcome

Timeframe: Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=40 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=32 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
ACR-N - Part B	36.839 units on a scale Standard Deviation 42.241	33.154 units on a scale Standard Deviation 32.439	39.922 units on a scale Standard Deviation 37.930	34.847 units on a scale Standard Deviation 69.410	38.996 units on a scale Standard Deviation 30.715	49.152 units on a scale Standard Deviation 31.544	22.230 units on a scale Standard Deviation 54.682	14.389 units on a scale Standard Deviation 45.461	30.891 units on a scale Standard Deviation 41.415

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.

The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=53 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=36 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A	5.566 units on a scale Standard Deviation 9.168	5.725 units on a scale Standard Deviation 8.706	6.057 units on a scale Standard Deviation 13.512	8.924 units on a scale Standard Deviation 9.469	7.250 units on a scale Standard Deviation 9.245	5.838 units on a scale Standard Deviation 7.946	4.953 units on a scale Standard Deviation 9.152	4.400 units on a scale Standard Deviation 8.068	6.627 units on a scale Standard Deviation 8.401

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.

The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in FACIT Fatigue Scale - Part B	8.390 units on a scale Standard Deviation 8.405	4.879 units on a scale Standard Deviation 10.810	8.500 units on a scale Standard Deviation 12.880	9.177 units on a scale Standard Deviation 11.637	7.295 units on a scale Standard Deviation 10.436	6.038 units on a scale Standard Deviation 9.986	8.323 units on a scale Standard Deviation 9.304	4.341 units on a scale Standard Deviation 8.493	6.647 units on a scale Standard Deviation 9.639

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=34 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=58 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A	-36.6 minutes Standard Deviation 123.7	-24.3 minutes Standard Deviation 87.3	-52.7 minutes Standard Deviation 142.0	-71.4 minutes Standard Deviation 143.9	-63.0 minutes Standard Deviation 57.0	-69.0 minutes Standard Deviation 64.1	-36.3 minutes Standard Deviation 137.7	-62.0 minutes Standard Deviation 138.1	-43.1 minutes Standard Deviation 116.7

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=27 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=25 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B	-92.1 minutes Standard Deviation 111.3	-70.2 minutes Standard Deviation 112.3	-55.6 minutes Standard Deviation 72.9	-92.3 minutes Standard Deviation 136.7	-68.8 minutes Standard Deviation 72.5	-82.3 minutes Standard Deviation 79.2	-61.3 minutes Standard Deviation 161.9	-60.9 minutes Standard Deviation 164.7	-85.9 minutes Standard Deviation 74.8

SECONDARY outcome

Timeframe: Baseline, up to Week 12

Population: Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.

HAQ-DI 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-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=56 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=64 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in HAQ-DI - Part A	-0.220 units on a scale Standard Deviation 0.459	-0.322 units on a scale Standard Deviation 0.493	-0.418 units on a scale Standard Deviation 0.693	-0.537 units on a scale Standard Deviation 0.639	-0.469 units on a scale Standard Deviation 0.517	-0.476 units on a scale Standard Deviation 0.655	-0.182 units on a scale Standard Deviation 0.458	-0.223 units on a scale Standard Deviation 0.448	-0.265 units on a scale Standard Deviation 0.496

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.

HAQ-DI 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-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI 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.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=41 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=33 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=28 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=31 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=44 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=26 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=31 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=41 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=34 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Change From Baseline in HAQ-DI - Part B	-0.616 units on a scale Standard Deviation 0.609	-0.542 units on a scale Standard Deviation 0.611	-0.665 units on a scale Standard Deviation 0.662	-0.673 units on a scale Standard Deviation 0.705	-0.554 units on a scale Standard Deviation 0.614	-0.697 units on a scale Standard Deviation 0.571	-0.331 units on a scale Standard Deviation 0.449	-0.250 units on a scale Standard Deviation 0.460	-0.309 units on a scale Standard Deviation 0.437

SECONDARY outcome

Timeframe: Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6

Population: All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.

Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=40 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=35 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=37 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=57 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=37 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=65 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=59 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=390 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State	336 nanograms per milliliter (ng/mL) Interval 138.0 to 783.0	1060 nanograms per milliliter (ng/mL) Interval 352.0 to 2580.0	3230 nanograms per milliliter (ng/mL) Interval 1140.0 to 7970.0	7580 nanograms per milliliter (ng/mL) Interval 2590.0 to 18600.0	17100 nanograms per milliliter (ng/mL) Interval 6870.0 to 42000.0	7320 nanograms per milliliter (ng/mL) Interval 2740.0 to 17700.0	16200 nanograms per milliliter (ng/mL) Interval 6040.0 to 40600.0	18600 nanograms per milliliter (ng/mL) Interval 8040.0 to 45000.0	—

SECONDARY outcome

Timeframe: Week 16, Week 64

Population: Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.

Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.

Outcome measures

Outcome measures
Measure	Placebo (bDMARD-naive Population) n=54 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	3 mg LY2439821 (bDMARD-naive Population) n=40 Participants 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	10 mg LY2439821 (bDMARD-naive Population) n=35 Participants 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	30 mg LY2439821 (bDMARD-naive Population) n=37 Participants 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (bDMARD-naive Population) n=57 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (bDMARD-naive Population) n=37 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	Placebo (TNFα-IR Population) n=34 Participants Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	80 mg LY2439821 (TNFα-IR Population) n=65 Participants 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.	180 mg LY2439821 (TNFα-IR Population) n=59 Participants 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Percentage of Participants With Anti-LY2439821 Antibodies Part A Week 16 (n=43,35,34,35,49,33,52,57,51)	11.6 percentage of participants	14.3 percentage of participants	8.8 percentage of participants	8.6 percentage of participants	16.3 percentage of participants	15.2 percentage of participants	7.7 percentage of participants	10.5 percentage of participants	13.7 percentage of participants
Percentage of Participants With Anti-LY2439821 Antibodies Part B Week 64 (n=37,32,28,30,40,26,31,41,33)	0.0 percentage of participants	0.0 percentage of participants	3.6 percentage of participants	0.0 percentage of participants	2.5 percentage of participants	3.8 percentage of participants	6.5 percentage of participants	0.0 percentage of participants	9.1 percentage of participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	3 mg LY2439821 (bDMARD-naive Population) Part A n=40 participants at risk 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg LY2439821 (bDMARD-naive Population) Part A n=35 participants at risk 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg LY2439821 (bDMARD-naive Population) Part A n=37 participants at risk 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 (bDMARD-naive Population) Part A n=57 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821(bDMARD-naive Population) Part A n=37 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo (bDMARD-naive Population) Part A n=54 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 (TNFa-IR Population) Part A n=65 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821 (TNFa-IR Population) Part A n=59 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo (TNFa-IR Population) Part A n=64 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=36 participants at risk 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=33 participants at risk 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=34 participants at risk 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=51 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=32 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B n=46 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg/160 mg LY2439821 (TNFa-IR Population) Part B n=57 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg/160 mg LY2439821 (TNFa-IR Population) Part B n=50 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo/160 mg LY2439821 (TNFa-IR Population) Part B n=51 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Blood and lymphatic system disorders Anaemia	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 2	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Cardiac disorders Atrial fibrillation	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Cardiac disorders Cardiac failure congestive	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Cardiac disorders Mitral valve incompetence	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Cardiac disorders Myocardial infarction	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	2.0% 1/51 • Number of events 2	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Cardiac disorders Ventricular extrasystoles	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	2.0% 1/51 • Number of events 1	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Pancreatitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 1	0.00% 0/51
Gastrointestinal disorders Pancreatitis acute	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	3.0% 1/33 • Number of events 2	2.9% 1/34 • Number of events 1	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
General disorders Death	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
General disorders Device dislocation	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 3	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
General disorders Non-cardiac chest pain	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
General disorders Systemic inflammatory response syndrome	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Hepatobiliary disorders Cholecystitis acute	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Immune system disorders Serum sickness-like reaction	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	2.7% 1/37 • Number of events 1	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Appendicitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Bronchitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Infections and infestations Cellulitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Empyema	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Meningitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	3.1% 1/32 • Number of events 1	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Pneumonia	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	2.9% 1/34 • Number of events 1	2.0% 1/51 • Number of events 1	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Pyelonephritis acute	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	2.8% 1/36 • Number of events 1	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Sepsis	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Staphylococcal bacteraemia	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Infections and infestations Upper respiratory tract infection	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Infections and infestations Urinary tract infection	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Urosepsis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Infections and infestations Whipple's disease	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Animal bite	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 1	0.00% 0/51
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Injury, poisoning and procedural complications Fall	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Femur fracture	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	2.8% 1/36 • Number of events 1	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	1.6% 1/64 • Number of events 1	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Pneumoconiosis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	2.9% 1/34 • Number of events 1	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Radius fracture	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	2.0% 1/51 • Number of events 1	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 1	0.00% 0/51
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	2.0% 1/51 • Number of events 1	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/33	0.00% 0/27	0.00% 0/31	0.00% 0/52	0.00% 0/30	0.00% 0/47	0.00% 0/57	0.00% 0/51	0.00% 0/55	0.00% 0/29	0.00% 0/25	0.00% 0/29	0.00% 0/46	0.00% 0/25	0.00% 0/40	0.00% 0/49	2.2% 1/45 • Number of events 1	0.00% 0/45
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/33	0.00% 0/27	0.00% 0/31	0.00% 0/52	0.00% 0/30	0.00% 0/47	0.00% 0/57	0.00% 0/51	0.00% 0/55	0.00% 0/29	0.00% 0/25	0.00% 0/29	0.00% 0/46	0.00% 0/25	0.00% 0/40	0.00% 0/49	2.2% 1/45 • Number of events 1	0.00% 0/45
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/33	0.00% 0/27	0.00% 0/31	0.00% 0/52	0.00% 0/30	0.00% 0/47	0.00% 0/57	2.0% 1/51 • Number of events 1	0.00% 0/55	0.00% 0/29	0.00% 0/25	0.00% 0/29	0.00% 0/46	0.00% 0/25	0.00% 0/40	0.00% 0/49	0.00% 0/45	0.00% 0/45
Nervous system disorders Hypoaesthesia	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Nervous system disorders Intracranial aneurysm	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	2.8% 1/36 • Number of events 1	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Nervous system disorders Ischaemic stroke	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	1.9% 1/54 • Number of events 1	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Nervous system disorders Sciatica	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Nervous system disorders Syncope	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Psychiatric disorders Anxiety	0.00% 0/40	0.00% 0/35	2.7% 1/37 • Number of events 1	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Renal and urinary disorders Renal colic	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Renal and urinary disorders Renal failure acute	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Surgical and medical procedures Arthrodesis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
Vascular disorders Aortic aneurysm	0.00% 0/40	2.9% 1/35 • Number of events 1	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Vascular disorders Shock haemorrhagic	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1

Other adverse events

Other adverse events
Measure	3 mg LY2439821 (bDMARD-naive Population) Part A n=40 participants at risk 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg LY2439821 (bDMARD-naive Population) Part A n=35 participants at risk 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg LY2439821 (bDMARD-naive Population) Part A n=37 participants at risk 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 (bDMARD-naive Population) Part A n=57 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821(bDMARD-naive Population) Part A n=37 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo (bDMARD-naive Population) Part A n=54 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg LY2439821 (TNFa-IR Population) Part A n=65 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg LY2439821 (TNFa-IR Population) Part A n=59 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo (TNFa-IR Population) Part A n=64 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=36 participants at risk 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=33 participants at risk 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=34 participants at risk 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=51 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B n=32 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B n=46 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	80 mg/160 mg LY2439821 (TNFa-IR Population) Part B n=57 participants at risk 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	180 mg/160 mg LY2439821 (TNFa-IR Population) Part B n=50 participants at risk 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.	Placebo/160 mg LY2439821 (TNFa-IR Population) Part B n=51 participants at risk Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Blood and lymphatic system disorders Leukopenia	5.0% 2/40 • Number of events 2	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	2.8% 1/36 • Number of events 1	6.1% 2/33 • Number of events 3	0.00% 0/34	2.0% 1/51 • Number of events 1	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Blood and lymphatic system disorders Neutropenia	2.5% 1/40 • Number of events 1	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	2.8% 1/36 • Number of events 1	6.1% 2/33 • Number of events 3	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Ear and labyrinth disorders Vertigo	2.5% 1/40 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	3.1% 2/65 • Number of events 2	1.7% 1/59 • Number of events 1	1.6% 1/64 • Number of events 1	0.00% 0/36	0.00% 0/33	0.00% 0/34	3.9% 2/51 • Number of events 2	3.1% 1/32 • Number of events 1	2.2% 1/46 • Number of events 1	1.8% 1/57 • Number of events 2	2.0% 1/50 • Number of events 1	5.9% 3/51 • Number of events 3
Eye disorders Conjunctivitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	2.7% 1/37 • Number of events 1	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	5.9% 3/51 • Number of events 4
Gastrointestinal disorders Abdominal pain upper	2.5% 1/40 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 3	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	5.9% 2/34 • Number of events 2	3.9% 2/51 • Number of events 2	0.00% 0/32	4.3% 2/46 • Number of events 2	3.5% 2/57 • Number of events 2	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Number of events 1	0.00% 0/35	2.7% 1/37 • Number of events 1	3.5% 2/57 • Number of events 3	0.00% 0/37	0.00% 0/54	4.6% 3/65 • Number of events 5	5.1% 3/59 • Number of events 3	4.7% 3/64 • Number of events 4	8.3% 3/36 • Number of events 3	0.00% 0/33	0.00% 0/34	3.9% 2/51 • Number of events 2	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	4.0% 2/50 • Number of events 2	0.00% 0/51
Gastrointestinal disorders Dyspepsia	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	1.6% 1/64 • Number of events 1	5.6% 2/36 • Number of events 2	3.0% 1/33 • Number of events 1	2.9% 1/34 • Number of events 1	2.0% 1/51 • Number of events 1	0.00% 0/32	2.2% 1/46 • Number of events 1	1.8% 1/57 • Number of events 1	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Gastritis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	2.7% 1/37 • Number of events 1	0.00% 0/54	0.00% 0/65	0.00% 0/59	1.6% 1/64 • Number of events 1	0.00% 0/36	6.1% 2/33 • Number of events 2	0.00% 0/34	2.0% 1/51 • Number of events 1	3.1% 1/32 • Number of events 1	2.2% 1/46 • Number of events 1	0.00% 0/57	2.0% 1/50 • Number of events 1	2.0% 1/51 • Number of events 2
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	6.1% 2/33 • Number of events 2	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Mouth ulceration	2.5% 1/40 • Number of events 1	0.00% 0/35	0.00% 0/37	0.00% 0/57	2.7% 1/37 • Number of events 1	3.7% 2/54 • Number of events 3	0.00% 0/65	0.00% 0/59	1.6% 1/64 • Number of events 1	5.6% 2/36 • Number of events 2	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	6.2% 2/32 • Number of events 2	6.5% 3/46 • Number of events 6	0.00% 0/57	0.00% 0/50	0.00% 0/51
Gastrointestinal disorders Nausea	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	5.4% 2/37 • Number of events 2	3.7% 2/54 • Number of events 3	0.00% 0/65	1.7% 1/59 • Number of events 1	7.8% 5/64 • Number of events 5	2.8% 1/36 • Number of events 1	6.1% 2/33 • Number of events 2	0.00% 0/34	7.8% 4/51 • Number of events 5	0.00% 0/32	0.00% 0/46	3.5% 2/57 • Number of events 2	4.0% 2/50 • Number of events 2	0.00% 0/51
Gastrointestinal disorders Vomiting	0.00% 0/40	0.00% 0/35	0.00% 0/37	3.5% 2/57 • Number of events 2	0.00% 0/37	3.7% 2/54 • Number of events 2	3.1% 2/65 • Number of events 2	0.00% 0/59	3.1% 2/64 • Number of events 2	5.6% 2/36 • Number of events 5	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	5.3% 3/57 • Number of events 4	2.0% 1/50 • Number of events 1	0.00% 0/51
General disorders Injection site erythema	5.0% 2/40 • Number of events 2	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	4.6% 3/65 • Number of events 7	8.5% 5/59 • Number of events 13	3.1% 2/64 • Number of events 2	5.6% 2/36 • Number of events 2	6.1% 2/33 • Number of events 3	0.00% 0/34	3.9% 2/51 • Number of events 4	0.00% 0/32	2.2% 1/46 • Number of events 4	5.3% 3/57 • Number of events 8	8.0% 4/50 • Number of events 7	5.9% 3/51 • Number of events 7
General disorders Injection site haematoma	0.00% 0/40	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	8.5% 5/59 • Number of events 6	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	2.0% 1/51 • Number of events 1
General disorders Injection site pain	2.5% 1/40 • Number of events 3	2.9% 1/35 • Number of events 1	2.7% 1/37 • Number of events 1	3.5% 2/57 • Number of events 2	5.4% 2/37 • Number of events 5	1.9% 1/54 • Number of events 3	9.2% 6/65 • Number of events 7	11.9% 7/59 • Number of events 8	4.7% 3/64 • Number of events 3	2.8% 1/36 • Number of events 6	3.0% 1/33 • Number of events 1	2.9% 1/34 • Number of events 1	3.9% 2/51 • Number of events 2	0.00% 0/32	8.7% 4/46 • Number of events 14	0.00% 0/57	2.0% 1/50 • Number of events 2	9.8% 5/51 • Number of events 22
General disorders Injection site reaction	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	4.6% 3/65 • Number of events 4	5.1% 3/59 • Number of events 5	1.6% 1/64 • Number of events 2	2.8% 1/36 • Number of events 1	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	7.0% 4/57 • Number of events 8	4.0% 2/50 • Number of events 2	2.0% 1/51 • Number of events 1
General disorders Oedema peripheral	0.00% 0/40	2.9% 1/35 • Number of events 1	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	5.6% 3/54 • Number of events 4	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	3.1% 2/64 • Number of events 2	0.00% 0/36	0.00% 0/33	2.9% 1/34 • Number of events 1	2.0% 1/51 • Number of events 2	3.1% 1/32 • Number of events 1	2.2% 1/46 • Number of events 1	3.5% 2/57 • Number of events 2	2.0% 1/50 • Number of events 1	3.9% 2/51 • Number of events 2
General disorders Pyrexia	0.00% 0/40	2.9% 1/35 • Number of events 2	5.4% 2/37 • Number of events 2	3.5% 2/57 • Number of events 2	0.00% 0/37	3.7% 2/54 • Number of events 4	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	0.00% 0/64	5.6% 2/36 • Number of events 3	3.0% 1/33 • Number of events 4	2.9% 1/34 • Number of events 1	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Bronchitis	5.0% 2/40 • Number of events 2	2.9% 1/35 • Number of events 1	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	3.4% 2/59 • Number of events 2	1.6% 1/64 • Number of events 1	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Cellulitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	6.1% 2/33 • Number of events 3	2.9% 1/34 • Number of events 1	3.9% 2/51 • Number of events 2	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Gastroenteritis	0.00% 0/40	2.9% 1/35 • Number of events 1	0.00% 0/37	0.00% 0/57	0.00% 0/37	1.9% 1/54 • Number of events 1	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	0.00% 0/36	6.1% 2/33 • Number of events 2	2.9% 1/34 • Number of events 1	0.00% 0/51	3.1% 1/32 • Number of events 1	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 1	3.9% 2/51 • Number of events 2
Infections and infestations Nasopharyngitis	5.0% 2/40 • Number of events 4	5.7% 2/35 • Number of events 3	0.00% 0/37	5.3% 3/57 • Number of events 3	8.1% 3/37 • Number of events 3	5.6% 3/54 • Number of events 3	4.6% 3/65 • Number of events 3	1.7% 1/59 • Number of events 1	6.2% 4/64 • Number of events 4	8.3% 3/36 • Number of events 4	12.1% 4/33 • Number of events 4	8.8% 3/34 • Number of events 6	3.9% 2/51 • Number of events 2	9.4% 3/32 • Number of events 4	10.9% 5/46 • Number of events 5	10.5% 6/57 • Number of events 9	2.0% 1/50 • Number of events 1	2.0% 1/51 • Number of events 2
Infections and infestations Paronychia	2.5% 1/40 • Number of events 1	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	6.2% 2/32 • Number of events 2	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Pharyngitis	0.00% 0/40	0.00% 0/35	2.7% 1/37 • Number of events 1	1.8% 1/57 • Number of events 1	5.4% 2/37 • Number of events 2	0.00% 0/54	0.00% 0/65	1.7% 1/59 • Number of events 1	0.00% 0/64	2.8% 1/36 • Number of events 1	6.1% 2/33 • Number of events 2	2.9% 1/34 • Number of events 1	0.00% 0/51	3.1% 1/32 • Number of events 1	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Rhinitis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	3.1% 2/65 • Number of events 3	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	6.2% 2/32 • Number of events 2	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	2.0% 1/51 • Number of events 1
Infections and infestations Sinusitis	0.00% 0/40	0.00% 0/35	2.7% 1/37 • Number of events 1	0.00% 0/57	2.7% 1/37 • Number of events 1	0.00% 0/54	3.1% 2/65 • Number of events 2	0.00% 0/59	4.7% 3/64 • Number of events 3	0.00% 0/36	3.0% 1/33 • Number of events 1	0.00% 0/34	2.0% 1/51 • Number of events 1	3.1% 1/32 • Number of events 1	0.00% 0/46	5.3% 3/57 • Number of events 3	2.0% 1/50 • Number of events 1	7.8% 4/51 • Number of events 4
Infections and infestations Upper respiratory tract infection	2.5% 1/40 • Number of events 1	0.00% 0/35	8.1% 3/37 • Number of events 3	5.3% 3/57 • Number of events 3	5.4% 2/37 • Number of events 2	0.00% 0/54	6.2% 4/65 • Number of events 5	10.2% 6/59 • Number of events 6	10.9% 7/64 • Number of events 7	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Urinary tract infection	2.5% 1/40 • Number of events 1	5.7% 2/35 • Number of events 2	8.1% 3/37 • Number of events 3	3.5% 2/57 • Number of events 2	5.4% 2/37 • Number of events 3	7.4% 4/54 • Number of events 5	6.2% 4/65 • Number of events 4	8.5% 5/59 • Number of events 5	3.1% 2/64 • Number of events 2	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Infections and infestations Vaginal infection	3.0% 1/33 • Number of events 1	3.7% 1/27 • Number of events 1	0.00% 0/31	0.00% 0/52	0.00% 0/30	2.1% 1/47 • Number of events 1	0.00% 0/57	0.00% 0/51	0.00% 0/55	0.00% 0/29	0.00% 0/25	0.00% 0/29	0.00% 0/46	0.00% 0/25	5.0% 2/40 • Number of events 2	0.00% 0/49	0.00% 0/45	0.00% 0/45
Infections and infestations Viral upper respiratory tract infection	0.00% 0/40	0.00% 0/35	5.4% 2/37 • Number of events 2	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	6.1% 2/33 • Number of events 2	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Investigations Alanine aminotransferase increased	5.0% 2/40 • Number of events 2	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	1.9% 1/54 • Number of events 1	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	3.0% 1/33 • Number of events 1	0.00% 0/34	3.9% 2/51 • Number of events 2	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	2.0% 1/50 • Number of events 6	0.00% 0/51
Investigations Aspartate aminotransferase increased	5.0% 2/40 • Number of events 2	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	1.9% 1/54 • Number of events 1	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	6.1% 2/33 • Number of events 2	0.00% 0/34	3.9% 2/51 • Number of events 2	0.00% 0/32	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 6	0.00% 0/51
Investigations Body temperature increased	0.00% 0/40	5.7% 2/35 • Number of events 2	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	2.0% 1/50 • Number of events 1	0.00% 0/51
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 3/40 • Number of events 5	0.00% 0/35	2.7% 1/37 • Number of events 2	0.00% 0/57	8.1% 3/37 • Number of events 3	1.9% 1/54 • Number of events 3	3.1% 2/65 • Number of events 2	1.7% 1/59 • Number of events 1	1.6% 1/64 • Number of events 1	0.00% 0/36	3.0% 1/33 • Number of events 1	2.9% 1/34 • Number of events 1	0.00% 0/51	0.00% 0/32	0.00% 0/46	3.5% 2/57 • Number of events 2	2.0% 1/50 • Number of events 1	7.8% 4/51 • Number of events 5
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40	5.7% 2/35 • Number of events 2	0.00% 0/37	1.8% 1/57 • Number of events 1	0.00% 0/37	1.9% 1/54 • Number of events 1	1.5% 1/65 • Number of events 1	6.8% 4/59 • Number of events 4	0.00% 0/64	2.8% 1/36 • Number of events 1	6.1% 2/33 • Number of events 2	5.9% 2/34 • Number of events 3	5.9% 3/51 • Number of events 4	3.1% 1/32 • Number of events 1	0.00% 0/46	0.00% 0/57	6.0% 3/50 • Number of events 3	0.00% 0/51
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.5% 1/40 • Number of events 1	5.7% 2/35 • Number of events 2	5.4% 2/37 • Number of events 2	3.5% 2/57 • Number of events 2	0.00% 0/37	1.9% 1/54 • Number of events 1	4.6% 3/65 • Number of events 4	8.5% 5/59 • Number of events 6	3.1% 2/64 • Number of events 2	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	0.00% 0/59	0.00% 0/64	5.6% 2/36 • Number of events 2	3.0% 1/33 • Number of events 1	2.9% 1/34 • Number of events 1	2.0% 1/51 • Number of events 1	0.00% 0/32	0.00% 0/46	3.5% 2/57 • Number of events 3	0.00% 0/50	2.0% 1/51 • Number of events 1
Nervous system disorders Burning sensation	0.00% 0/40	0.00% 0/35	5.4% 2/37 • Number of events 2	0.00% 0/57	0.00% 0/37	0.00% 0/54	3.1% 2/65 • Number of events 3	5.1% 3/59 • Number of events 4	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	0.00% 0/57	0.00% 0/50	0.00% 0/51
Nervous system disorders Dizziness	2.5% 1/40 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/37	1.8% 1/57 • Number of events 1	2.7% 1/37 • Number of events 1	3.7% 2/54 • Number of events 2	1.5% 1/65 • Number of events 1	3.4% 2/59 • Number of events 2	3.1% 2/64 • Number of events 2	5.6% 2/36 • Number of events 2	6.1% 2/33 • Number of events 2	0.00% 0/34	3.9% 2/51 • Number of events 2	3.1% 1/32 • Number of events 1	0.00% 0/46	5.3% 3/57 • Number of events 4	2.0% 1/50 • Number of events 1	0.00% 0/51
Nervous system disorders Headache	0.00% 0/40	11.4% 4/35 • Number of events 4	5.4% 2/37 • Number of events 2	3.5% 2/57 • Number of events 2	2.7% 1/37 • Number of events 1	11.1% 6/54 • Number of events 7	10.8% 7/65 • Number of events 7	3.4% 2/59 • Number of events 2	7.8% 5/64 • Number of events 6	2.8% 1/36 • Number of events 1	3.0% 1/33 • Number of events 2	0.00% 0/34	3.9% 2/51 • Number of events 2	3.1% 1/32 • Number of events 2	4.3% 2/46 • Number of events 2	3.5% 2/57 • Number of events 3	4.0% 2/50 • Number of events 2	5.9% 3/51 • Number of events 3
Psychiatric disorders Insomnia	2.5% 1/40 • Number of events 1	0.00% 0/35	0.00% 0/37	1.8% 1/57 • Number of events 1	5.4% 2/37 • Number of events 2	0.00% 0/54	3.1% 2/65 • Number of events 2	3.4% 2/59 • Number of events 2	0.00% 0/64	2.8% 1/36 • Number of events 1	3.0% 1/33 • Number of events 1	0.00% 0/34	0.00% 0/51	3.1% 1/32 • Number of events 2	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51
Renal and urinary disorders Dysuria	2.5% 1/40 • Number of events 1	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	1.9% 1/54 • Number of events 1	0.00% 0/65	0.00% 0/59	0.00% 0/64	5.6% 2/36 • Number of events 2	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	0.00% 0/46	1.8% 1/57 • Number of events 1	0.00% 0/50	2.0% 1/51 • Number of events 1
Renal and urinary disorders Nephrolithiasis	0.00% 0/40	0.00% 0/35	0.00% 0/37	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	2.0% 1/51 • Number of events 1	0.00% 0/32	6.5% 3/46 • Number of events 3	1.8% 1/57 • Number of events 1	2.0% 1/50 • Number of events 1	0.00% 0/51
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/7	0.00% 0/8	0.00% 0/6	0.00% 0/5	0.00% 0/7	0.00% 0/7	0.00% 0/8	0.00% 0/8	0.00% 0/9	0.00% 0/7	0.00% 0/8	0.00% 0/5	0.00% 0/5	0.00% 0/7	16.7% 1/6 • Number of events 1	0.00% 0/8	0.00% 0/5	0.00% 0/6
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40 • Number of events 2	0.00% 0/35	2.7% 1/37 • Number of events 2	0.00% 0/57	0.00% 0/37	0.00% 0/54	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	0.00% 0/64	0.00% 0/36	0.00% 0/33	5.9% 2/34 • Number of events 2	5.9% 3/51 • Number of events 3	9.4% 3/32 • Number of events 3	4.3% 2/46 • Number of events 2	0.00% 0/57	2.0% 1/50 • Number of events 1	3.9% 2/51 • Number of events 3
Vascular disorders Hypertension	0.00% 0/40	5.7% 2/35 • Number of events 2	5.4% 2/37 • Number of events 3	7.0% 4/57 • Number of events 4	2.7% 1/37 • Number of events 1	0.00% 0/54	1.5% 1/65 • Number of events 1	1.7% 1/59 • Number of events 1	1.6% 1/64 • Number of events 1	2.8% 1/36 • Number of events 1	3.0% 1/33 • Number of events 1	2.9% 1/34 • Number of events 1	2.0% 1/51 • Number of events 1	6.2% 2/32 • Number of events 5	4.3% 2/46 • Number of events 2	3.5% 2/57 • Number of events 2	4.0% 2/50 • Number of events 2	2.0% 1/51 • Number of events 2
Vascular disorders Hypotension	0.00% 0/40	0.00% 0/35	5.4% 2/37 • Number of events 3	0.00% 0/57	0.00% 0/37	0.00% 0/54	0.00% 0/65	0.00% 0/59	0.00% 0/64	0.00% 0/36	0.00% 0/33	0.00% 0/34	0.00% 0/51	0.00% 0/32	2.2% 1/46 • Number of events 1	0.00% 0/57	0.00% 0/50	0.00% 0/51

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60