Trial Outcomes & Findings for Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis (NCT NCT00883896)

Last Updated: 2022-10-21

Results Overview

ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

195 participants

Primary outcome timeframe

Week 12

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	ILV-094 200 mg Every 2 Weeks Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	Placebo Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Overall Study STARTED	48	66	39	42
Overall Study COMPLETED	41	60	39	41
Overall Study NOT COMPLETED	7	6	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ILV-094 200 mg Every 2 Weeks Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	Placebo Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Overall Study Lost to Follow-up	2	0	0
Overall Study Withdrawal by Subject	3	5	1
Overall Study Lack of Efficacy	2	0	0
Overall Study Other	0	1	0

Baseline Characteristics

Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	Total n=195 Participants Total of all reporting groups
Age, Continuous	56.91 years STANDARD_DEVIATION 11.01 • n=5 Participants	59.95 years STANDARD_DEVIATION 10.30 • n=7 Participants	55.14 years STANDARD_DEVIATION 10.80 • n=5 Participants	54.90 years STANDARD_DEVIATION 11.11 • n=4 Participants	56.64 years STANDARD_DEVIATION 10.93 • n=21 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	38 Participants n=4 Participants	156 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	39 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12	50.0 Percentage of participants Interval 37.4 to 62.6	43.6 Percentage of participants Interval 27.8 to 60.4	38.1 Percentage of participants Interval 23.6 to 54.4	50.0 Percentage of participants Interval 35.2 to 64.8

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

ACR20 response: \>=20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 2	18.2 Percentage of participants Interval 9.8 to 29.6	17.9 Percentage of participants Interval 7.5 to 33.5	14.3 Percentage of participants Interval 5.4 to 28.5	14.6 Percentage of participants Interval 6.1 to 27.8
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 4	24.2 Percentage of participants Interval 14.5 to 36.4	33.3 Percentage of participants Interval 19.1 to 50.2	21.4 Percentage of participants Interval 10.3 to 36.8	27.1 Percentage of participants Interval 15.3 to 41.8
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 6	33.3 Percentage of participants Interval 22.2 to 46.0	46.2 Percentage of participants Interval 30.1 to 62.8	23.8 Percentage of participants Interval 12.1 to 39.5	39.6 Percentage of participants Interval 25.8 to 54.7
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 8	31.8 Percentage of participants Interval 20.9 to 44.4	48.7 Percentage of participants Interval 32.4 to 65.2	33.3 Percentage of participants Interval 19.6 to 49.5	35.4 Percentage of participants Interval 22.2 to 50.5
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 10	42.4 Percentage of participants Interval 30.3 to 55.2	56.4 Percentage of participants Interval 39.6 to 72.2	42.9 Percentage of participants Interval 27.7 to 59.0	31.3 Percentage of participants Interval 18.7 to 46.3

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

ACR50 response: \>=50 percent improvement in tender joint count; \>=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 2	3.0 Percentage of participants Interval 0.4 to 10.5	2.6 Percentage of participants Interval 0.1 to 13.5	9.5 Percentage of participants Interval 2.7 to 22.6	0.0 Percentage of participants Interval 0.0 to 7.4
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 4	6.1 Percentage of participants Interval 1.7 to 14.8	7.7 Percentage of participants Interval 1.6 to 20.9	7.1 Percentage of participants Interval 1.5 to 19.5	4.2 Percentage of participants Interval 0.5 to 14.3
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 6	9.1 Percentage of participants Interval 3.4 to 18.7	7.7 Percentage of participants Interval 1.6 to 20.9	14.3 Percentage of participants Interval 5.4 to 28.5	12.5 Percentage of participants Interval 4.7 to 25.2
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 8	7.6 Percentage of participants Interval 2.5 to 16.8	12.8 Percentage of participants Interval 4.3 to 27.4	4.8 Percentage of participants Interval 0.6 to 16.2	14.6 Percentage of participants Interval 6.1 to 27.8
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 10	18.2 Percentage of participants Interval 9.8 to 29.6	17.9 Percentage of participants Interval 7.5 to 33.5	9.5 Percentage of participants Interval 2.7 to 22.6	18.8 Percentage of participants Interval 8.9 to 32.6
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 12	15.2 Percentage of participants Interval 7.5 to 26.1	23.1 Percentage of participants Interval 11.1 to 39.3	14.3 Percentage of participants Interval 5.4 to 28.5	14.6 Percentage of participants Interval 6.1 to 27.8

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

ACR70 response:\>=70 percent improvement in tender joint count; \>=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 12	4.5 Percentage of participants Interval 0.9 to 12.7	5.1 Percentage of participants Interval 0.6 to 17.3	4.8 Percentage of participants Interval 0.6 to 16.2	2.1 Percentage of participants Interval 0.1 to 11.1
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 2	0.0 Percentage of participants Interval 0.0 to 5.4	2.6 Percentage of participants Interval 0.1 to 13.5	2.4 Percentage of participants Interval 0.1 to 12.6	0.0 Percentage of participants Interval 0.0 to 7.4
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 4	1.5 Percentage of participants Interval 0.0 to 8.2	2.6 Percentage of participants Interval 0.1 to 13.5	7.1 Percentage of participants Interval 1.5 to 19.5	0.0 Percentage of participants Interval 0.0 to 7.4
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 6	0.0 Percentage of participants Interval 0.0 to 5.4	2.6 Percentage of participants Interval 0.1 to 13.5	2.4 Percentage of participants Interval 0.1 to 12.6	2.1 Percentage of participants Interval 0.1 to 11.1
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 8	0.0 Percentage of participants Interval 0.0 to 5.4	2.6 Percentage of participants Interval 0.1 to 13.5	0.0 Percentage of participants Interval 0.0 to 8.4	4.2 Percentage of participants Interval 0.5 to 14.3
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 10	0.0 Percentage of participants Interval 0.0 to 5.4	5.1 Percentage of participants Interval 0.6 to 17.3	2.4 Percentage of participants Interval 0.1 to 12.6	2.1 Percentage of participants Interval 0.1 to 11.1

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter \[mg/L\]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm \[very well\] to 100mm \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 implied remission.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Baseline	5.6 Units on a scale Standard Deviation 0.8	5.5 Units on a scale Standard Deviation 0.9	5.3 Units on a scale Standard Deviation 0.8	5.5 Units on a scale Standard Deviation 0.8
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 2	5.1 Units on a scale Standard Deviation 1.0	5.1 Units on a scale Standard Deviation 1.1	4.9 Units on a scale Standard Deviation 1.4	5.2 Units on a scale Standard Deviation 1.0
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 4	4.9 Units on a scale Standard Deviation 1.1	4.8 Units on a scale Standard Deviation 0.9	4.6 Units on a scale Standard Deviation 1.4	5.0 Units on a scale Standard Deviation 1.1
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 6	4.7 Units on a scale Standard Deviation 1.2	4.4 Units on a scale Standard Deviation 1.2	4.6 Units on a scale Standard Deviation 1.2	4.6 Units on a scale Standard Deviation 1.2
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 8	4.6 Units on a scale Standard Deviation 1.3	4.4 Units on a scale Standard Deviation 1.1	4.4 Units on a scale Standard Deviation 1.2	4.4 Units on a scale Standard Deviation 1.3
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 10	4.5 Units on a scale Standard Deviation 1.3	4.2 Units on a scale Standard Deviation 1.2	4.4 Units on a scale Standard Deviation 1.2	4.5 Units on a scale Standard Deviation 1.3
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Week 12	4.4 Units on a scale Standard Deviation 1.3	4.2 Units on a scale Standard Deviation 1.4	4.3 Units on a scale Standard Deviation 1.3	4.4 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 or even partial dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.

DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour \[mm/hour\]); and general health VAS score (participant rated scale with scores ranging from 0 \[very well\] to 100 \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 implied remission.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Baseline	6.4 Units on a scale Standard Deviation 0.7	6.4 Units on a scale Standard Deviation 0.8	6.2 Units on a scale Standard Deviation 0.7	6.3 Units on a scale Standard Deviation 0.8
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 2	5.8 Units on a scale Standard Deviation 1.1	5.9 Units on a scale Standard Deviation 1.1	5.6 Units on a scale Standard Deviation 1.4	5.9 Units on a scale Standard Deviation 0.8
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 4	5.5 Units on a scale Standard Deviation 1.3	5.6 Units on a scale Standard Deviation 0.9	5.3 Units on a scale Standard Deviation 1.3	5.7 Units on a scale Standard Deviation 0.9
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 6	5.4 Units on a scale Standard Deviation 1.3	5.2 Units on a scale Standard Deviation 1.1	5.3 Units on a scale Standard Deviation 1.2	5.2 Units on a scale Standard Deviation 1.2
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 8	5.3 Units on a scale Standard Deviation 1.3	5.2 Units on a scale Standard Deviation 1.1	5.0 Units on a scale Standard Deviation 1.3	5.1 Units on a scale Standard Deviation 1.2
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 10	5.2 Units on a scale Standard Deviation 1.4	5.0 Units on a scale Standard Deviation 1.2	5.0 Units on a scale Standard Deviation 1.3	5.1 Units on a scale Standard Deviation 1.3
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Week 12	5.1 Units on a scale Standard Deviation 1.3	5.0 Units on a scale Standard Deviation 1.4	5.0 Units on a scale Standard Deviation 1.3	5.1 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Tender Joints Counts (TJC) Baseline	13.4 Tender joints Standard Deviation 5.2	13.2 Tender joints Standard Deviation 6.3	12.3 Tender joints Standard Deviation 5.9	14.4 Tender joints Standard Deviation 5.9
Tender Joints Counts (TJC) Week 2	11.1 Tender joints Standard Deviation 6.0	10.9 Tender joints Standard Deviation 7.1	10.8 Tender joints Standard Deviation 7.8	12.5 Tender joints Standard Deviation 6.4
Tender Joints Counts (TJC) Week 4	10.4 Tender joints Standard Deviation 6.6	9.5 Tender joints Standard Deviation 7.1	9.5 Tender joints Standard Deviation 6.7	11.2 Tender joints Standard Deviation 6.5
Tender Joints Counts (TJC) Week 6	9.5 Tender joints Standard Deviation 7.1	8.1 Tender joints Standard Deviation 7.5	9.2 Tender joints Standard Deviation 7.8	9.3 Tender joints Standard Deviation 6.4
Tender Joints Counts (TJC) Week 8	9.2 Tender joints Standard Deviation 7.2	7.8 Tender joints Standard Deviation 7.2	7.9 Tender joints Standard Deviation 7.2	9.3 Tender joints Standard Deviation 6.6
Tender Joints Counts (TJC) Week 10	8.4 Tender joints Standard Deviation 7.0	7.2 Tender joints Standard Deviation 6.9	8.0 Tender joints Standard Deviation 7.1	9.5 Tender joints Standard Deviation 7.0
Tender Joints Counts (TJC) Week 12	7.7 Tender joints Standard Deviation 6.4	7.4 Tender joints Standard Deviation 8.0	7.8 Tender joints Standard Deviation 7.7	9.2 Tender joints Standard Deviation 7.0

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Swollen Joints Count (SJC) Week 8	6.4 Swollen joints Standard Deviation 5.4	6.0 Swollen joints Standard Deviation 6.0	5.0 Swollen joints Standard Deviation 4.9	5.6 Swollen joints Standard Deviation 5.2
Swollen Joints Count (SJC) Baseline	10.2 Swollen joints Standard Deviation 3.8	10.0 Swollen joints Standard Deviation 4.6	9.4 Swollen joints Standard Deviation 4.6	10.0 Swollen joints Standard Deviation 4.1
Swollen Joints Count (SJC) Week 2	8.2 Swollen joints Standard Deviation 5.0	8.4 Swollen joints Standard Deviation 5.2	6.9 Swollen joints Standard Deviation 5.2	8.0 Swollen joints Standard Deviation 4.7
Swollen Joints Count (SJC) Week 4	7.0 Swollen joints Standard Deviation 4.9	6.8 Swollen joints Standard Deviation 5.1	5.8 Swollen joints Standard Deviation 5.0	7.0 Swollen joints Standard Deviation 5.0
Swollen Joints Count (SJC) Week 6	6.6 Swollen joints Standard Deviation 5.3	5.7 Swollen joints Standard Deviation 5.4	6.0 Swollen joints Standard Deviation 5.8	5.9 Swollen joints Standard Deviation 5.1
Swollen Joints Count (SJC) Week 10	5.9 Swollen joints Standard Deviation 5.8	5.4 Swollen joints Standard Deviation 5.5	5.2 Swollen joints Standard Deviation 5.2	5.9 Swollen joints Standard Deviation 5.8
Swollen Joints Count (SJC) Week 12	5.5 Swollen joints Standard Deviation 5.6	5.6 Swollen joints Standard Deviation 5.9	5.0 Swollen joints Standard Deviation 5.3	5.5 Swollen joints Standard Deviation 5.9

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Physician Global Assessment of Disease Activity Week 12	4.0 Units on a scale Standard Deviation 2.2	3.7 Units on a scale Standard Deviation 2.1	3.6 Units on a scale Standard Deviation 1.9	3.9 Units on a scale Standard Deviation 2.1
Physician Global Assessment of Disease Activity Baseline	6.2 Units on a scale Standard Deviation 1.6	6.3 Units on a scale Standard Deviation 1.5	6.0 Units on a scale Standard Deviation 1.7	6.0 Units on a scale Standard Deviation 1.6
Physician Global Assessment of Disease Activity Week 2	5.4 Units on a scale Standard Deviation 1.9	5.2 Units on a scale Standard Deviation 1.8	5.1 Units on a scale Standard Deviation 2.1	5.1 Units on a scale Standard Deviation 1.7
Physician Global Assessment of Disease Activity Week 4	4.7 Units on a scale Standard Deviation 1.9	4.9 Units on a scale Standard Deviation 1.8	4.6 Units on a scale Standard Deviation 2.2	4.9 Units on a scale Standard Deviation 1.9
Physician Global Assessment of Disease Activity Week 6	4.4 Units on a scale Standard Deviation 1.8	4.5 Units on a scale Standard Deviation 1.9	4.3 Units on a scale Standard Deviation 1.8	4.3 Units on a scale Standard Deviation 2.0
Physician Global Assessment of Disease Activity Week 8	4.5 Units on a scale Standard Deviation 2.1	3.9 Units on a scale Standard Deviation 1.6	3.9 Units on a scale Standard Deviation 1.9	4.1 Units on a scale Standard Deviation 2.0
Physician Global Assessment of Disease Activity Week 10	4.2 Units on a scale Standard Deviation 2.3	3.6 Units on a scale Standard Deviation 1.7	3.9 Units on a scale Standard Deviation 1.9	4.2 Units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Participants answered: "considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Participant Global Assessment of Disease Activity Baseline	6.2 Units on a scale Standard Deviation 1.8	6.0 Units on a scale Standard Deviation 1.8	6.3 Units on a scale Standard Deviation 1.7	5.9 Units on a scale Standard Deviation 2.1
Participant Global Assessment of Disease Activity Week 2	5.5 Units on a scale Standard Deviation 2.3	5.5 Units on a scale Standard Deviation 2.1	5.6 Units on a scale Standard Deviation 2.4	5.7 Units on a scale Standard Deviation 2.2
Participant Global Assessment of Disease Activity Week 4	5.2 Units on a scale Standard Deviation 2.1	5.0 Units on a scale Standard Deviation 2.2	5.6 Units on a scale Standard Deviation 2.2	5.5 Units on a scale Standard Deviation 2.0
Participant Global Assessment of Disease Activity Week 6	5.0 Units on a scale Standard Deviation 2.0	4.7 Units on a scale Standard Deviation 2.2	5.4 Units on a scale Standard Deviation 1.8	5.1 Units on a scale Standard Deviation 2.1
Participant Global Assessment of Disease Activity Week 8	5.1 Units on a scale Standard Deviation 2.1	4.6 Units on a scale Standard Deviation 2.3	5.5 Units on a scale Standard Deviation 1.9	4.8 Units on a scale Standard Deviation 2.0
Participant Global Assessment of Disease Activity Week 10	5.0 Units on a scale Standard Deviation 2.3	4.0 Units on a scale Standard Deviation 2.4	5.2 Units on a scale Standard Deviation 2.1	5.0 Units on a scale Standard Deviation 2.2
Participant Global Assessment of Disease Activity Week 12	4.7 Units on a scale Standard Deviation 2.1	4.5 Units on a scale Standard Deviation 2.4	5.0 Units on a scale Standard Deviation 2.0	4.8 Units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Pain Visual Analog Scale (VAS) Baseline	58.0 Millimeter Standard Deviation 21.2	56.0 Millimeter Standard Deviation 19.1	56.6 Millimeter Standard Deviation 18.7	56.5 Millimeter Standard Deviation 23.6
Pain Visual Analog Scale (VAS) Week 2	49.8 Millimeter Standard Deviation 23.5	48.3 Millimeter Standard Deviation 24.0	51.7 Millimeter Standard Deviation 23.7	52.3 Millimeter Standard Deviation 21.5
Pain Visual Analog Scale (VAS) Week 4	46.8 Millimeter Standard Deviation 23.7	45.9 Millimeter Standard Deviation 23.9	54.7 Millimeter Standard Deviation 22.0	52.6 Millimeter Standard Deviation 20.7
Pain Visual Analog Scale (VAS) Week 6	48.8 Millimeter Standard Deviation 23.6	45.2 Millimeter Standard Deviation 23.5	48.8 Millimeter Standard Deviation 18.9	46.7 Millimeter Standard Deviation 21.7
Pain Visual Analog Scale (VAS) Week 8	47.3 Millimeter Standard Deviation 24.4	38.9 Millimeter Standard Deviation 23.5	49.0 Millimeter Standard Deviation 22.8	44.1 Millimeter Standard Deviation 21.2
Pain Visual Analog Scale (VAS) Week 10	45.2 Millimeter Standard Deviation 26.1	37.7 Millimeter Standard Deviation 24.6	46.2 Millimeter Standard Deviation 24.0	44.7 Millimeter Standard Deviation 23.5
Pain Visual Analog Scale (VAS) Week 12	44.0 Millimeter Standard Deviation 25.0	39.9 Millimeter Standard Deviation 23.9	44.9 Millimeter Standard Deviation 22.4	42.6 Millimeter Standard Deviation 19.9

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

General health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health currently concerning the arthritis?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
General Health Visual Analog Scale (VAS) Baseline	60.8 Millimeter Standard Deviation 18.4	59.2 Millimeter Standard Deviation 21.2	61.0 Millimeter Standard Deviation 16.4	57.7 Millimeter Standard Deviation 20.7
General Health Visual Analog Scale (VAS) Week 2	54.1 Millimeter Standard Deviation 22.4	52.5 Millimeter Standard Deviation 23.0	53.0 Millimeter Standard Deviation 23.7	54.8 Millimeter Standard Deviation 19.8
General Health Visual Analog Scale (VAS) Week 4	48.8 Millimeter Standard Deviation 23.0	48.2 Millimeter Standard Deviation 22.9	54.3 Millimeter Standard Deviation 23.1	52.9 Millimeter Standard Deviation 20.2
General Health Visual Analog Scale (VAS) Week 6	50.7 Millimeter Standard Deviation 22.0	42.4 Millimeter Standard Deviation 21.9	52.5 Millimeter Standard Deviation 19.4	48.8 Millimeter Standard Deviation 21.9
General Health Visual Analog Scale (VAS) Week 8	47.5 Millimeter Standard Deviation 24.1	40.4 Millimeter Standard Deviation 23.8	50.3 Millimeter Standard Deviation 22.2	45.4 Millimeter Standard Deviation 21.5
General Health Visual Analog Scale (VAS) Week 10	48.4 Millimeter Standard Deviation 25.7	38.9 Millimeter Standard Deviation 22.2	46.9 Millimeter Standard Deviation 24.0	45.7 Millimeter Standard Deviation 23.3
General Health Visual Analog Scale (VAS) Week 12	47.6 Millimeter Standard Deviation 25.4	40.6 Millimeter Standard Deviation 23.0	47.4 Millimeter Standard Deviation 22.0	43.2 Millimeter Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline, Week 4, 2, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline	1.4 Units on a scale Standard Deviation 0.7	1.3 Units on a scale Standard Deviation 0.7	1.3 Units on a scale Standard Deviation 0.6	1.3 Units on a scale Standard Deviation 0.7
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 2	1.3 Units on a scale Standard Deviation 0.7	1.3 Units on a scale Standard Deviation 0.7	1.2 Units on a scale Standard Deviation 0.7	1.3 Units on a scale Standard Deviation 0.6
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 4	1.3 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.6	1.3 Units on a scale Standard Deviation 0.7	1.2 Units on a scale Standard Deviation 0.7
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 6	1.2 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7	1.2 Units on a scale Standard Deviation 0.6	1.2 Units on a scale Standard Deviation 0.7
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 8	1.2 Units on a scale Standard Deviation 0.6	1.1 Units on a scale Standard Deviation 0.7	1.2 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 10	1.2 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7	1.2 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 12	1.2 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7	1.1 Units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12

SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
36-Item Short-Form Health Survey (SF-36) Baseline: PCS	33.8 Units on a scale Standard Deviation 7.8	34.9 Units on a scale Standard Deviation 5.8	34.8 Units on a scale Standard Deviation 6.6	34.4 Units on a scale Standard Deviation 8.3
36-Item Short-Form Health Survey (SF-36) Baseline: MCS	40.5 Units on a scale Standard Deviation 12.3	42.0 Units on a scale Standard Deviation 12.0	41.2 Units on a scale Standard Deviation 11.0	41.1 Units on a scale Standard Deviation 13.0
36-Item Short-Form Health Survey (SF-36) Week 4: PCS	36.0 Units on a scale Standard Deviation 8.2	36.9 Units on a scale Standard Deviation 8.5	36.0 Units on a scale Standard Deviation 8.6	36.5 Units on a scale Standard Deviation 7.7
36-Item Short-Form Health Survey (SF-36) Week 4: MCS	42.7 Units on a scale Standard Deviation 12.4	43.0 Units on a scale Standard Deviation 13.0	41.0 Units on a scale Standard Deviation 12.2	40.3 Units on a scale Standard Deviation 12.4
36-Item Short-Form Health Survey (SF-36) Week 8: PCS	35.8 Units on a scale Standard Deviation 7.5	37.3 Units on a scale Standard Deviation 8.5	36.6 Units on a scale Standard Deviation 7.1	36.9 Units on a scale Standard Deviation 8.1
36-Item Short-Form Health Survey (SF-36) Week 8: MCS	44.5 Units on a scale Standard Deviation 11.3	44.8 Units on a scale Standard Deviation 12.0	43.1 Units on a scale Standard Deviation 11.9	42.9 Units on a scale Standard Deviation 11.3
36-Item Short-Form Health Survey (SF-36) Week 12: PCS	36.7 Units on a scale Standard Deviation 7.7	37.6 Units on a scale Standard Deviation 8.6	36.3 Units on a scale Standard Deviation 8.7	37.1 Units on a scale Standard Deviation 9.4
36-Item Short-Form Health Survey (SF-36) Week 12: MCS	43.2 Units on a scale Standard Deviation 11.8	44.2 Units on a scale Standard Deviation 11.7	44.2 Units on a scale Standard Deviation 12.6	44.5 Units on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.

FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, "I have energy" and "I am able to do my usual activities"), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline	29.1 Units on a scale Standard Deviation 10.9	30.9 Units on a scale Standard Deviation 10.9	30.6 Units on a scale Standard Deviation 9.4	29.2 Units on a scale Standard Deviation 11.7
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 4	31.7 Units on a scale Standard Deviation 10.7	33.6 Units on a scale Standard Deviation 11.3	32.6 Units on a scale Standard Deviation 9.8	30.7 Units on a scale Standard Deviation 10.6
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 8	32.7 Units on a scale Standard Deviation 10.8	33.7 Units on a scale Standard Deviation 10.4	32.1 Units on a scale Standard Deviation 9.9	32.3 Units on a scale Standard Deviation 10.7
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 12	33.3 Units on a scale Standard Deviation 9.4	34.3 Units on a scale Standard Deviation 9.5	32.4 Units on a scale Standard Deviation 9.5	33.2 Units on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12

Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

DAS28-based EULAR response criteria was used to measure individual response as none, good and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 Participants Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 Participants Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 Participants Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 8: Moderate	29 Participants	18 Participants	16 Participants	19 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 2: Good	3 Participants	1 Participants	5 Participants	0 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 2: Moderate	15 Participants	10 Participants	7 Participants	9 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 2: None	47 Participants	28 Participants	30 Participants	39 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 4: Good	4 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 4: Moderate	20 Participants	13 Participants	9 Participants	15 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 4: None	41 Participants	24 Participants	27 Participants	32 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 6: Good	7 Participants	4 Participants	4 Participants	5 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 6: Moderate	27 Participants	20 Participants	11 Participants	18 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 6: None	31 Participants	15 Participants	27 Participants	25 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 8: Good	8 Participants	5 Participants	4 Participants	8 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 8: None	28 Participants	16 Participants	22 Participants	21 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 10: Good	13 Participants	6 Participants	6 Participants	7 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 10: Moderate	28 Participants	22 Participants	15 Participants	21 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 10: None	24 Participants	11 Participants	21 Participants	20 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 12: Good	12 Participants	11 Participants	7 Participants	9 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 12: Moderate	33 Participants	16 Participants	18 Participants	20 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 12: None	20 Participants	12 Participants	17 Participants	19 Participants

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

ILV-094 100 mg Every 4 Weeks

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

ILV-094 100 mg Every 2 Weeks

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

ILV-094 200 mg Every 2 Weeks

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=66 participants at risk Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 participants at risk Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 participants at risk Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 participants at risk Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Blood and lymphatic system disorders Anaemia	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis acute	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Gait disturbance	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Bile duct obstruction	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Testicular abscess	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral ischaemia	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events
Measure	Placebo n=66 participants at risk Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 4 Weeks n=39 participants at risk Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 100 mg Every 2 Weeks n=42 participants at risk Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.	ILV-094 200 mg Every 2 Weeks n=48 participants at risk Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration.
Renal and urinary disorders Dysuria	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Liver function test abnormal	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Coagulation test abnormal	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Costovertebral angle tenderness	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle strain	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Thermal burn	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.1% 2/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure increased	3.0% 2/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Cardiac murmur	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	3.0% 2/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 2/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 3/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.1% 2/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.1% 2/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.1% 2/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/66 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/39 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.