Trial Outcomes & Findings for Canakinumab for Treatment of Adult-onset Still's Disease (NCT NCT02204293)

NCT ID: NCT02204293

Last Updated: 2020-08-07

Results Overview

Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score \> 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Week 12

Results posted on

2020-08-07

Participant Flow

Participants with adult-onset Still's disease (AOSD) took part in the study from June 21, 2012 to May 5, 2018 at 14 investigative sites located in Germany to participate in two double-blind parts - Part I (Up to Week 12) and Part II (Up to Week 24) and one open-label Long-Term Extension (LTE) phase (Up to Month 27).

A total of 36 participants entered in Part I to receive canakinumab/placebo. Out of 31, 5 participants from canakinumab arm, and 3 from placebo arm did not enter Part II, 23 participants entered Part II and received canakinumab or placebo up to Week 24. 7 participants who achieved clinical remission entered LTE Phase to receive canakinumab.

Participant milestones

Participant milestones
Measure	Core Study Part I: Canakinumab Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I STARTED	19	17	0	0	0	0
Core Study Part I Intention-to-treat Population	18	17	0	0	0	0
Core Study Part I Safety Population	20	15	0	0	0	0
Core Study Part I COMPLETED	17	14	0	0	0	0
Core Study Part I NOT COMPLETED	2	3	0	0	0	0
Core Study Part 2 STARTED	0	0	12	4	7	0
Core Study Part 2 Safety Population	0	0	14	2	7	0
Core Study Part 2 COMPLETED	0	0	12	4	7	0
Core Study Part 2 NOT COMPLETED	0	0	0	0	0	0
LTE Phase STARTED	0	0	0	0	0	7
LTE Phase COMPLETED	0	0	0	0	0	0
LTE Phase NOT COMPLETED	0	0	0	0	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Core Study Part I: Canakinumab Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I Met one or more exclusion criteria	1	0	0
Core Study Part I Adverse Event	1	0	0
Core Study Part I Physician Decision	0	3	0
LTE Phase Study Suspended	0	0	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Total n=35 Participants Total of all reporting groups
Age, Continuous	41.06 years STANDARD_DEVIATION 13.2 • n=18 Participants	40.53 years STANDARD_DEVIATION 13.2 • n=17 Participants	40.79 years STANDARD_DEVIATION 13.2 • n=35 Participants
Sex: Female, Male Female	10 Participants n=18 Participants	13 Participants n=17 Participants	23 Participants n=35 Participants
Sex: Female, Male Male	8 Participants n=18 Participants	4 Participants n=17 Participants	12 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Week 12

Population: Intention-to-treat (ITT) population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12	66.7 percentage of participants Interval 43.1 to 85.2	41.2 percentage of participants Interval 20.1 to 65.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

Population: ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.

The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score Baseline	5.37 score on a scale Interval 4.7 to 6.0	5.3 score on a scale Interval 4.6 to 6.0	—	—	—	—
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score CFB at Week 4	3.56 score on a scale Interval 2.9 to 4.3	4.27 score on a scale Interval 3.5 to 5.0	—	—	—	—
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score CFB at Week 8	2.86 score on a scale Interval 2.2 to 3.6	3.92 score on a scale Interval 3.1 to 4.7	—	—	—	—
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score CFB at Week 12	3.1 score on a scale Interval 2.4 to 3.8	4.0 score on a scale Interval 3.3 to 4.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score Baseline	5.0 score on a scale Interval 4.4 to 5.6	5.07 score on a scale Interval 4.4 to 5.7	—	—	—	—
Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score CFB at Week 4	3.4 score on a scale Interval 2.8 to 4.0	4.01 score on a scale Interval 3.3 to 4.7	—	—	—	—
Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score CFB at Week 8	2.8 score on a scale Interval 2.2 to 3.4	3.81 score on a scale Interval 3.1 to 4.5	—	—	—	—
Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score CFB at Week 12	3.31 score on a scale Interval 2.7 to 3.9	4.01 score on a scale Interval 3.3 to 4.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC) Baseline	8.89 tender joints Interval 4.9 to 12.9	11.18 tender joints Interval 7.1 to 15.3	—	—	—	—
Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC) CFB at Week 4	5.33 tender joints Interval 1.3 to 9.3	5.85 tender joints Interval 1.5 to 10.2	—	—	—	—
Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC) CFB at Week 8	3.72 tender joints Interval -0.3 to 7.7	5.1 tender joints Interval 0.6 to 9.6	—	—	—	—
Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC) CFB at Week 12	4.66 tender joints Interval 0.6 to 8.7	6.9 tender joints Interval 2.6 to 11.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC) Baseline	5.78 swollen joints Interval 3.6 to 7.9	8.0 swollen joints Interval 5.8 to 10.2	—	—	—	—
Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC) CFB at Week 4	2.5 swollen joints Interval 0.4 to 4.6	2.5 swollen joints Interval 0.1 to 4.9	—	—	—	—
Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC) CFB at Week 8	1.33 swollen joints Interval -0.8 to 3.5	2.65 swollen joints Interval 0.2 to 5.0	—	—	—	—
Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC) CFB at Week 12	2.89 swollen joints Interval 0.7 to 5.1	4.71 swollen joints Interval 2.4 to 7.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in the 28 TJC Baseline	6.78 tender joints Interval 4.6 to 9.0	7.24 tender joints Interval 5.0 to 9.5	—	—	—	—
Core Study Part I: CFB in the 28 TJC CFB at Week 4	3.67 tender joints Interval 1.5 to 5.9	4.29 tender joints Interval 1.9 to 6.7	—	—	—	—
Core Study Part I: CFB in the 28 TJC CFB at Week 8	2.39 tender joints Interval 0.2 to 4.6	3.85 tender joints Interval 1.4 to 6.3	—	—	—	—
Core Study Part I: CFB in the 28 TJC CFB at Week 12	3.47 tender joints Interval 1.2 to 5.7	4.43 tender joints Interval 2.1 to 6.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in the 28 SJC Baseline	4.97 swollen joints Interval 3.4 to 6.6	6.29 swollen joints Interval 4.6 to 8.0	—	—	—	—
Core Study Part I: CFB in the 28 SJC CFB at Week 4	2.11 swollen joints Interval 0.5 to 3.7	2.47 swollen joints Interval 0.7 to 4.2	—	—	—	—
Core Study Part I: CFB in the 28 SJC CFB at Week 8	0.83 swollen joints Interval -0.8 to 2.5	2.79 swollen joints Interval 1.0 to 4.6	—	—	—	—
Core Study Part I: CFB in the 28 SJC CFB at Week 12	2.28 swollen joints Interval 0.6 to 3.9	4.51 swollen joints Interval 2.8 to 6.3	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP Baseline	45.55 milligrams per liter (mg/L) Interval 26.1 to 65.0	57.26 milligrams per liter (mg/L) Interval 37.3 to 77.2	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP CFB at Week 4	17.53 milligrams per liter (mg/L) Interval -2.1 to 37.1	36.74 milligrams per liter (mg/L) Interval 15.8 to 57.7	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP CFB at Week 8	14.61 milligrams per liter (mg/L) Interval -4.8 to 34.0	32.51 milligrams per liter (mg/L) Interval 11.2 to 53.8	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP CFB at Week 12	17.05 milligrams per liter (mg/L) Interval -2.6 to 36.7	28.52 milligrams per liter (mg/L) Interval 7.0 to 50.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR Baseline	44.11 millimeter per hour (mm/h) Interval 33.8 to 54.4	38.82 millimeter per hour (mm/h) Interval 28.3 to 49.4	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR CFB at Week 4	24.28 millimeter per hour (mm/h) Interval 13.8 to 34.7	38.6 millimeter per hour (mm/h) Interval 27.5 to 49.7	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR CFB at Week 8	25.4 millimeter per hour (mm/h) Interval 15.0 to 35.8	25.25 millimeter per hour (mm/h) Interval 13.6 to 36.9	—	—	—	—
Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR CFB at Week 12	15.85 millimeter per hour (mm/h) Interval 5.3 to 26.4	22.41 millimeter per hour (mm/h) Interval 10.8 to 34.0	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=17 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=14 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in Serum Ferritin Level at Week 12	466.9 nanograms per milliliter (ng/mL) Interval 16.0 to 918.0	634.71 nanograms per milliliter (ng/mL) Interval 170.0 to 1099.0	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With Fever Episodes	8.3 percentage of participants	0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score Baseline	5.5 score on a scale Interval 4.5 to 6.5	6.0 score on a scale Interval 4.9 to 7.1	—	—	—	—
Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score CFB at Week 4	3.06 score on a scale Interval 2.0 to 4.1	3.67 score on a scale Interval 2.5 to 4.8	—	—	—	—
Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score CFB at Week 8	2.72 score on a scale Interval 1.7 to 3.8	3.56 score on a scale Interval 2.4 to 4.7	—	—	—	—
Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score CFB at Week 12	2.86 score on a scale Interval 1.8 to 3.9	4.26 score on a scale Interval 3.1 to 5.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score Baseline	6.08 score on a scale Interval 4.9 to 7.3	5.85 score on a scale Interval 4.6 to 7.1	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score CFB at Week 4	3.78 score on a scale Interval 2.6 to 5.0	4.74 score on a scale Interval 3.4 to 6.0	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score CFB at Week 8	2.84 score on a scale Interval 1.6 to 4.0	4.58 score on a scale Interval 3.2 to 5.9	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score CFB at Week 12	3.63 score on a scale Interval 2.4 to 4.8	4.32 score on a scale Interval 3.0 to 5.6	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 12

The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score Baseline	6.61 score on a scale Interval 5.3 to 7.9	6.35 score on a scale Interval 5.0 to 7.7	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score CFB at Week 4	3.61 score on a scale Interval 2.3 to 4.9	4.85 score on a scale Interval 3.5 to 6.2	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score CFB at Week 8	2.73 score on a scale Interval 1.4 to 4.0	4.18 score on a scale Interval 2.7 to 5.6	—	—	—	—
Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score CFB at Week 12	3.71 score on a scale Interval 2.4 to 5.0	4.25 score on a scale Interval 2.8 to 5.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline	1.31 score on a scale Interval 0.9 to 1.7	1.29 score on a scale Interval 0.9 to 1.7	—	—	—	—
Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score CFB at Week 12	0.69 score on a scale Interval 0.3 to 1.1	0.98 score on a scale Interval 0.6 to 1.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)	61.1 percentage of participants Interval 37.7 to 81.1	41.2 percentage of participants Interval 20.1 to 65.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With ACR30	61.1 percentage of participants Interval 37.7 to 81.1	29.4 percentage of participants Interval 11.7 to 53.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With Modified ACR30	55.6 percentage of participants Interval 32.7 to 76.8	23.5 percentage of participants Interval 8.0 to 47.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With ACR50	50.0 percentage of participants Interval 27.8 to 72.2	17.6 percentage of participants Interval 4.7 to 40.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With ACR70	27.8 percentage of participants Interval 11.0 to 51.3	11.8 percentage of participants Interval 2.0 to 33.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With ACR90	11.1 percentage of participants Interval 1.9 to 32.1	5.9 percentage of participants Interval 0.3 to 25.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline \< -1.2. EULAR Moderate response: DAS28 \>3.2 to ≤ 5.1 or a change from Baseline \< -0.6 to ≥ -1.2 or EULAR No response: DAS28 \>5.1 or a change from Baseline \< -0.6 to ≤ -1.2.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response EULAR DAS28-ESR Response	77.8 percentage of participants Interval 54.7 to 92.5	52.9 percentage of participants Interval 29.7 to 75.2	—	—	—	—
Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response EULAR DAS28-CRP Response	72.2 percentage of participants Interval 48.7 to 89.0	47.1 percentage of participants Interval 24.8 to 70.3	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Percentage of responders were defined as the participants who achieved LDA (DAS28 score \< 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA) DAS28 (ESR) LDA	33.3 percentage of participants Interval 14.8 to 56.9	29.4 percentage of participants Interval 11.7 to 53.7	—	—	—	—
Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA) DAS28 (CRP) LDA	50.0 percentage of participants Interval 27.8 to 72.2	23.5 percentage of participants Interval 8.0 to 47.5	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Participants with disease remission: LDA (DAS28 score\< 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 \< 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of \> 10000/cubic millimeters (mm\^3) with \> 80% neutrophils.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission DAS28 (ESR) Remission	33.3 percentage of participants Interval 14.8 to 56.9	11.8 percentage of participants Interval 2.0 to 33.7	—	—	—	—
Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission DAS28 (CRP) Remission	38.9 percentage of participants Interval 18.9 to 62.3	11.8 percentage of participants Interval 2.0 to 33.7	—	—	—	—
Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission Extended Remission	27.8 percentage of participants Interval 11.0 to 51.3	11.8 percentage of participants Interval 2.0 to 33.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method Baseline	4.94 degrees Interval 3.0 to 6.9	6.29 degrees Interval 4.3 to 8.3	—	—	—	—
Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method Week 12	5.37 degrees Interval 3.4 to 7.3	6.05 degrees Interval 4.0 to 8.1	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=18 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=17 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score SF-36 Physical: Baseline	29.39 score on a scale Interval 24.5 to 34.3	28.73 score on a scale Interval 23.7 to 33.8	—	—	—	—
Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score SF-36 Physical: CFB at Week 12	41.03 score on a scale Interval 36.0 to 46.1	33.45 score on a scale Interval 27.9 to 39.0	—	—	—	—
Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score SF-36 Mental: Baseline	37.8 score on a scale Interval 32.0 to 43.6	46.31 score on a scale Interval 40.4 to 52.2	—	—	—	—
Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score SF-36 Mental: CFB at Week 12	43.47 score on a scale Interval 37.6 to 49.3	49.82 score on a scale Interval 43.6 to 56.1	—	—	—	—

SECONDARY outcome

Timeframe: Up to Month 27

Population: Safety Analysis Set included all participants randomized who received at least one dose of the study drug.

An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

Outcome measures

Outcome measures
Measure	Core Study Part I: Canakinumab n=20 Participants Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=15 Participants Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders n=14 Participants Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders n=2 Participants Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders n=7 Participants Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab n=7 Participants Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	16 Participants	10 Participants	13 Participants	2 Participants	6 Participants	7 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants

Adverse Events

Core Study Part I: Canakinumab

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Core Study Part I: Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Core Study Part II: Canakinumab Responders

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Core Study Part II: Placebo Responders

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Core Study Part II: Placebo Non-responders

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

LTE Phase: Canakinumab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Core Study Part I: Canakinumab n=20 participants at risk Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=15 participants at risk Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders n=14 participants at risk Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders n=2 participants at risk Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders n=7 participants at risk Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab n=7 participants at risk Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Hepatobiliary disorders Cholecystitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Hepatobiliary disorders Hepatotoxicity	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Injury, poisoning and procedural complications Fracture	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Chondromalacia	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Hypotonia	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Surgical and medical procedures Medical device removal	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Vascular disorders Deep vein thrombosis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.

Other adverse events

Other adverse events
Measure	Core Study Part I: Canakinumab n=20 participants at risk Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part I: Placebo n=15 participants at risk Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.	Core Study Part II: Canakinumab Responders n=14 participants at risk Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Responders n=2 participants at risk Participants with response (change in DAS score \> 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.	Core Study Part II: Placebo Non-responders n=7 participants at risk Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.	LTE Phase: Canakinumab n=7 participants at risk Participants with remission (change in DAS score \> 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).
Investigations Alanine aminotransferase increased	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Eye disorders Eyelid oedema	10.0% 2/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Eye disorders Visual impairment	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	13.3% 2/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Diarrhoea	10.0% 2/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	13.3% 2/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Gastrointestinal disorders Nausea	10.0% 2/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
General disorders Fatigue	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	13.3% 2/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
General disorders Influenza like illness	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 2/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	42.9% 3/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
General disorders Injection site rash	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
General disorders Pyrexia	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Hepatobiliary disorders Primary biliary cholangitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Bronchitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Gastrointestinal infection	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Herpes zoster	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Infected bite	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Nasopharyngitis	15.0% 3/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	20.0% 3/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	21.4% 3/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	42.9% 3/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Oral herpes	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Otitis media	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Periodontitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Pertussis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Respiratory tract infection	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Rhinitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Tooth abscess	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Infections and infestations Urinary tract infection	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Injury, poisoning and procedural complications Fall	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Injury, poisoning and procedural complications Meniscus injury	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Investigations Gamma-glutamyltransferase increased	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Investigations Hepatic enzyme increased	10.0% 2/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Investigations Transaminases increased	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 2/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 2/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Still's disease	25.0% 5/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 2/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Dizziness	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Headache	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	20.0% 3/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	28.6% 2/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Intercostal neuralgia	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Nervous system disorders Sciatica	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Psychiatric disorders Depression	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Psychiatric disorders Sleep disorder	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Renal and urinary disorders Dysuria	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Reproductive system and breast disorders Vulva cyst	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	28.6% 2/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Alopecia	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	6.7% 1/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	14.3% 1/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	28.6% 2/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	50.0% 1/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.
Vascular disorders Haematoma	5.0% 1/20 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/15 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	7.1% 1/14 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/2 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.	0.00% 0/7 • Up to Month 27 Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.

Additional Information

Prof. Dr Eugen Feist

Helios Fachklinik Vogelsang-Gommern GmbH, Germany

Phone: +49 30 450 513 192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place