Trial Outcomes & Findings for Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis (NCT NCT00554606)
NCT ID: NCT00554606
Last Updated: 2021-07-09
Results Overview
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
COMPLETED
PHASE2
115 participants
From start of the study up to End Of Study (Week 60)
2021-07-09
Participant Flow
A total of 115 participants were enrolled in the trial (56 from core trial CACZ885A2204, 8 from CACZ885A2206, and 51 from CACZ885A2207).
Participant milestones
| Measure |
Canakinumab (ACZ885)
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
85
|
Reasons for withdrawal
| Measure |
Canakinumab (ACZ885)
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Abnormal laboratory values
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
14
|
|
Overall Study
Subject withdrew consent
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Administrative problems
|
60
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol deviation
|
2
|
Baseline Characteristics
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
|---|---|
|
Age, Customized
|
52.3 years
STANDARD_DEVIATION 13.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of the study up to End Of Study (Week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
91 Participants
|
—
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Death
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Serious Adverse Events
|
8 Participants
|
—
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Discontinued due to Serious Adverse Events
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 48
|
53.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 54 (Follow-Up)
|
41.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
End of Study
|
45.9 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Baseline
|
48.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Day 1
|
49.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 6
|
57.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 12
|
53.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 18
|
58.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 24
|
54.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 30
|
61.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
WeeK 36
|
52.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
Week 42
|
57.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Day 1
|
23.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 24
|
32.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 30
|
32.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 36
|
35.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Baseline
|
23.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 6
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 12
|
30.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 18
|
26.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 42
|
38.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
Week 48
|
28.9 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
End of Study
|
26.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Day 1
|
11.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Baseline
|
12.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 6
|
13.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 12
|
13.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 18
|
14.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 24
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 30
|
18.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 36
|
20.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 42
|
26.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 48
|
13.3 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
Week 54 (Follow-Up)
|
14.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
End of Study
|
15.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all subjects that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR90 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 90% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Day 1
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 6
|
2.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 12
|
2.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 18
|
1.9 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 24
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 30
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 36
|
6.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 42
|
8.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 48
|
6.7 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Week 54 (Follow-Up)
|
10.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
End of Study
|
5.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
Baseline
|
2.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas: DAS28 = 0.56\*√ (tender28) + 0.28 \* √ (swollen28) + 0.36 \* loge(CRP+1) + 0.014\*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient's global assessment of disease activity and EGDA is the physician's global assessment of disease activity. The Number of Participants in clinical remission is defined as the DAS28 ≤ (less than or equal to) 2.6 or SDAI ≤ (less than or equal to) to3.3.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 30
|
24.1 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 54 (Follow-Up)
|
27.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Baseline
|
11.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Day 1
|
14.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 6
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 12
|
18.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 18
|
19.2 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 24
|
20.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 36
|
18.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 42
|
32.7 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
Week 48
|
17.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
End of study
|
18.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28\*(s/S)).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Day 1
|
6.5 Joints
Standard Deviation 5.53
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 6
|
5.8 Joints
Standard Deviation 5.65
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 12
|
5.2 Joints
Standard Deviation 5.16
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 18
|
5.0 Joints
Standard Deviation 5.18
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 24
|
4.4 Joints
Standard Deviation 4.35
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 42
|
3.8 Joints
Standard Deviation 4.60
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Baseline
|
6.0 Joints
Standard Deviation 5.10
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 30
|
3.9 Joints
Standard Deviation 4.37
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 36
|
3.5 Joints
Standard Deviation 4.65
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 48
|
4.4 Joints
Standard Deviation 4.99
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
Week 54 (Follow-Up)
|
3.9 Joints
Standard Deviation 5.22
|
—
|
|
Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
End of Study
|
5.1 Joints
Standard Deviation 5.18
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28\*(t/T)).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 24
|
7.1 Joints
Standard Deviation 7.40
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Baseline
|
9.3 Joints
Standard Deviation 7.70
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Day 1
|
9.5 Joints
Standard Deviation 8.11
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 6
|
8.7 Joints
Standard Deviation 7.70
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 12
|
7.9 Joints
Standard Deviation 7.17
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 18
|
7.7 Joints
Standard Deviation 7.15
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 30
|
6.9 Joints
Standard Deviation 7.54
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 36
|
6.9 Joints
Standard Deviation 7.19
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 42
|
3.8 Joints
Standard Deviation 6.12
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 48
|
4.9 Joints
Standard Deviation 6.33
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
Week 54 (Follow-Up)
|
5.9 Joints
Standard Deviation 7.11
|
—
|
|
Change From Baseline in ACR Component : Tender Joint Count Through Week 54
End of Study
|
7.6 Joints
Standard Deviation 7.25
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR components included patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 6
|
37.8 millimetres
Standard Deviation 21.16
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Baseline
|
42.3 millimetres
Standard Deviation 21.93
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Day 1
|
41.2 millimetres
Standard Deviation 21.60
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 12
|
37.1 millimetres
Standard Deviation 21.21
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 18
|
39.4 millimetres
Standard Deviation 21.35
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 24
|
36.8 millimetres
Standard Deviation 20.55
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 30
|
36.3 millimetres
Standard Deviation 21.13
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 36
|
36.5 millimetres
Standard Deviation 23.01
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 42
|
32.5 millimetres
Standard Deviation 21.11
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 48
|
33.0 millimetres
Standard Deviation 21.24
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
Week 54 (Follow-Up)
|
35.9 millimetres
Standard Deviation 22.12
|
—
|
|
Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
End of Study
|
40.1 millimetres
Standard Deviation 20.60
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR component included patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 36
|
39.9 millimeters
Standard Deviation 21.70
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Baseline
|
45.0 millimeters
Standard Deviation 23.05
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Day 1
|
44.1 millimeters
Standard Deviation 21.96
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 6
|
40.3 millimeters
Standard Deviation 22.02
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 12
|
39.9 millimeters
Standard Deviation 21.01
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 18
|
42.0 millimeters
Standard Deviation 20.89
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 24
|
38.3 millimeters
Standard Deviation 21.04
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 30
|
36.6 millimeters
Standard Deviation 21.97
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 42
|
31.2 millimeters
Standard Deviation 21.40
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 48
|
37.6 millimeters
Standard Deviation 23.08
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
Week 54 (Follow-Up)
|
38.4 millimeters
Standard Deviation 23.99
|
—
|
|
Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
End of Study
|
42.0 millimeters
Standard Deviation 21.77
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
ACR component included physician's global assessment (PGA) of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 48
|
23.3 millimeters
Standard Deviation 18.10
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Baseline
|
37.0 millimeters
Standard Deviation 23.11
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Day 1
|
38.7 millimeters
Standard Deviation 23.09
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 6
|
34.1 millimeters
Standard Deviation 22.70
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 12
|
33.0 millimeters
Standard Deviation 21.82
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 18
|
33.7 millimeters
Standard Deviation 22.06
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 24
|
27.8 millimeters
Standard Deviation 20.25
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 30
|
26.0 millimeters
Standard Deviation 16.79
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 36
|
24.6 millimeters
Standard Deviation 16.35
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 42
|
21.3 millimeters
Standard Deviation 17.25
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
Week 54 (Follow-Up)
|
27.6 millimeters
Standard Deviation 23.70
|
—
|
|
Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
End of Study
|
32.7 millimeters
Standard Deviation 22.88
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
Blood for this assessment was obtained in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. Assessment was performed by the central laboratory.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Baseline
|
14.42 milligrams/liter
Standard Deviation 22.406
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Day 1
|
15.30 milligrams/liter
Standard Deviation 26.827
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 6
|
10.38 milligrams/liter
Standard Deviation 16.717
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 12
|
10.10 milligrams/liter
Standard Deviation 19.355
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 18
|
9.99 milligrams/liter
Standard Deviation 16.948
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 24
|
8.35 milligrams/liter
Standard Deviation 16.413
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 30
|
8.03 milligrams/liter
Standard Deviation 14.065
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 36
|
6.49 milligrams/liter
Standard Deviation 10.146
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 42
|
5.71 milligrams/liter
Standard Deviation 10.577
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 48
|
6.72 milligrams/liter
Standard Deviation 11.545
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
Week 54 (Follow-Up)
|
6.71 milligrams/liter
Standard Deviation 12.611
|
—
|
|
Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
End of Study
|
10.74 milligrams/liter
Standard Deviation 22.520
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug. Here, number of participants (N) analyzed included all participants who were evaluable for this outcome measure and number analyzed (n) included all participants who were evaluable for the specified categories.
The MRI scan was scored according to OMERACT RAMRIS system. Erosions were scored on a scale of 0-10 per site, the scale is 0-10, based on the proportion of eroded bone compared to the "assessed bone volume", judged on all available images-0: no erosion; 1: 1-10% of bone eroded; 2; 11-20%, etc. For long bones, the "assessed bone volume" is from the articular surface (or its best estimated position if absent) to a depth of 1 cm, and in carpal bones it is the whole bone. Edema were scored on a scale of 0-10 per site, the scale is 0-3 based on the proportion of bone with edema, as follows-0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%; and Synovitis on a scale of 0-3 per site, the scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=32 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
n=15 Participants
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18
Edema Score
|
0 score on a scale
Interval -0.39 to 0.04
|
-0.043 score on a scale
Interval -0.86 to 3.0
|
|
Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18
Erosion Score
|
0 score on a scale
Interval -0.13 to 0.09
|
0 score on a scale
Interval -0.39 to 0.3
|
|
Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18
Synovitis Score
|
-0.143 score on a scale
Interval -1.86 to 0.57
|
-0.714 score on a scale
Interval -1.43 to 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug. Here, number of participants analyzed (N) included all participants who were evaluable for this outcome measure.
Digital radiographic (X-ray) assessment of 16 joints and bones in the hand and wrist were assessed for and 15 joints in the hand and wrist were assessed for joint space narrowing. Scoring of the radiographic assessment was according to modified Sharp/van der Heijde score. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively. Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet. For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, \<50% of the original joint space; 3=general, \>50% of the original joint space or subluxation; 4=ankylosis.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=33 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
n=16 Participants
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18
Left Foot
|
0 score on a scale
Interval -0.17 to 1.0
|
0 score on a scale
Interval 0.0 to 0.5
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18
Left Hand
|
0 score on a scale
Interval -0.06 to 0.13
|
0 score on a scale
Interval 0.0 to 0.63
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18
Right Hand
|
0 score on a scale
Interval 0.0 to 0.25
|
0 score on a scale
Interval 0.0 to 0.38
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18
Right Foot
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.67
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment. Here, N (number of participants analyzed) included all participants who were evaluable for this outcome measure.
Digital radiographic (X-ray) assessment of 16 joints and bones in the hand and wrist were assessed for and 15 joints in the hand and wrist were assessed for joint space narrowing. Scoring of the radiographic assessment was according to modified Sharp/van der Heijde score. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively. Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet. For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, \<50% of the original joint space; 3=general, \>50% of the original joint space or subluxation; 4=ankylosis.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=33 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
n=16 Participants
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18
Right Hand
|
0 score on a scale
Interval -0.07 to 0.07
|
0 score on a scale
Interval -0.07 to 0.07
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18
Left Hand
|
0 score on a scale
Interval 0.0 to 0.13
|
0 score on a scale
Interval -0.07 to 0.07
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18
Left Foot
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18
Right Foot
|
0 score on a scale
Interval 0.0 to 0.17
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug. Number of participants analyzed signifies those who were evaluable for the assessment. Here, N (number of participants analyzed) included all participants who were evaluable for this outcome measure.
Bone Mineral Density was measured by dual-energy X-ray absorptiometry (DXA) of the hand with the most swollen wrist (determined at baseline by the investigator site), lumbosacral (LS) spine and hip, in selected study sites. The reading of the DXA scans were performed centrally, by an experienced independent reader who was blinded to clinical details and MRI findings.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=4 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
n=1 Participants
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18
AP lumbar spine L1- L4
|
1.1650 g/cm2
Standard Deviation 0.36399
|
1.1760 g/cm2
|
|
Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18
Total Hip
|
0.9000 g/cm2
Standard Deviation 0.32558
|
0.8570 g/cm2
|
|
Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18
Total Hand
|
0.3295 g/cm2
Standard Deviation 0.09726
|
0.4280 g/cm2
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The Safety Analysis Set was defined as all participants that received at least one dose of study drug (in this extension) with at least one post-baseline safety assessment.
Anti-ACZ885 antibodies concentrations were assessed in serum. All blood samples were taken by direct venipuncture in a forearm vein. Immunogenicity was analyzed by BIAcore technology. immunogenicity was categorized as NO (no immunogenicity), BLQ (positive immunogenicity \< LLOQ (not quantifiable)), and ALQ (positive immunogenicity \> LLOQ (quantifiable).
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Number of Subjects With Long-term Immunogenicity
Baseline - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
Baseline - ALQ
|
1 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 6 - No immunogenicity
|
1 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 48 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
End of study - No immunogenicity
|
93 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
End of study - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
Baseline - No immunogenicity
|
108 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
DAY 1 - No immunogenicity
|
94 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
DAY 1 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
DAY 1 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 6 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 6 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 12 - No immunogenicity
|
89 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 12 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 12 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 24 - No immunogenicity
|
73 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 24 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 24 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 36 - No immunogenicity
|
46 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 36 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 36 - ALQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 48 - No immunogenicity
|
21 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
WEEK 48 - BLQ
|
0 Participants
|
—
|
|
Number of Subjects With Long-term Immunogenicity
End of study - ALQ
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60)Population: The PK set consisted of all participant who received at least one dose of study drug (in this extension) with at least one post-baseline pharmacokinetic assessment.
The PK parameter were evaluated from serum concentration-time data using mixed effects modeling approach.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Pharmacokinetic (PK) of ACZ885: Systemic Clearance From Serum Following Intravenous Administration (CL) in Participants
|
0.210 Litre/day (L/d)
Standard Deviation 0.0741
|
—
|
SECONDARY outcome
Timeframe: Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60)Population: The PK set consisted of all participants who received at least one dose of study drug (in this extension) with at least one post-baseline pharmacokinetic assessment.
The PK parameter were evaluated from serum concentration-time data using mixed effects modeling approach.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Pharmacokinetic (PK) of ACZ885: Volume Distribution From Serum Following Intravenous Administration (CL) in Participants
|
3.34 Litre (L)
Standard Deviation 1.03
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The safety population consisted of all randomized participants who received at least one dose of the study drug.
The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score.The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
Week 24
|
39.437 score on a scale
Standard Deviation 9.2349
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
Baseline
|
38.115 score on a scale
Standard Deviation 9.9799
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
Week 12
|
39.374 score on a scale
Standard Deviation 9.7656
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
Week 36
|
38.264 score on a scale
Standard Deviation 10.0517
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
Week 48
|
40.110 score on a scale
Standard Deviation 10.3660
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
End Of Study
|
38.295 score on a scale
Standard Deviation 9.4491
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The safety population consisted of all randomized participants who received at least one dose of the study drug.
HAQ assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3 where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question.A decrease from baseline indicates improvement for HAQ-DI. The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater disability.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Baseline
|
1.107 units on a scale
Standard Deviation 0.6957
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Day 1
|
1.039 units on a scale
Standard Deviation 0.7271
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 6
|
0.981 units on a scale
Standard Deviation 0.6990
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 12
|
1.044 units on a scale
Standard Deviation 0.6924
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 18
|
1.061 units on a scale
Standard Deviation 0.7182
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 24
|
0.997 units on a scale
Standard Deviation 0.7224
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 30
|
0.993 units on a scale
Standard Deviation 0.7223
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 36
|
1.008 units on a scale
Standard Deviation 0.7450
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 42
|
0.814 units on a scale
Standard Deviation 0.8368
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 48
|
0.837 units on a scale
Standard Deviation 0.7529
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
Week 54 (Follow-Up)
|
0.859 units on a scale
Standard Deviation 0.7231
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
End of Study
|
1.089 units on a scale
Standard Deviation 0.7350
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End Of Study (up to week 60)Population: The safety population consisted of all randomized participants who received at least one dose of the study drug.
The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score.The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health.
Outcome measures
| Measure |
Canakinumab (ACZ885)
n=115 Participants
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
Non- ACZ885 ( (Core Trial CACZ885A2204))
Participant who did not receive ACZ885 (Canakinumab) in the core trial CACZ885A2204.
|
|---|---|---|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
Baseline
|
44.947 score on a scale
Standard Deviation 11.9800
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
Week 12
|
45.867 score on a scale
Standard Deviation 12.5364
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
Week 24
|
44.701 score on a scale
Standard Deviation 11.9993
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
Week 36
|
45.175 score on a scale
Standard Deviation 12.1436
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
Week 48
|
49.993 score on a scale
Standard Deviation 13.0069
|
—
|
|
Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
End Of Study
|
42.346 score on a scale
Standard Deviation 11.8792
|
—
|
Adverse Events
Canakinumab (ACZ885)
Serious adverse events
| Measure |
Canakinumab (ACZ885)
n=115 participants at risk
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
|---|---|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Lumbar Pain
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Eye disorders
Intermediate Uveitis
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Injury, poisoning and procedural complications
Burn of internal organs
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.87%
1/115 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
Other adverse events
| Measure |
Canakinumab (ACZ885)
n=115 participants at risk
Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
4/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
3/115 • Number of events 3 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
4/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Gastrointestinal disorders
Nausea
|
4.3%
5/115 • Number of events 6 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
General disorders
Odema peripheral
|
3.5%
4/115 • Number of events 5 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Infections and infestations
Bronchitis
|
7.0%
8/115 • Number of events 9 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Infections and infestations
Gastroenteritis
|
2.6%
3/115 • Number of events 3 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Infections and infestations
Respiratory tract infection viral
|
6.1%
7/115 • Number of events 11 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Investigations
Blood pressure increased
|
2.6%
3/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
6/115 • Number of events 6 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
5/115 • Number of events 6 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Investigations
Hepatic enzyme increased
|
3.5%
4/115 • Number of events 5 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
4/115 • Number of events 5 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
7/115 • Number of events 9 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.2%
6/115 • Number of events 9 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Nervous system disorders
Headache
|
9.6%
11/115 • Number of events 13 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
3/115 • Number of events 3 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
2.6%
3/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
|
Vascular disorders
Hypertension
|
3.5%
4/115 • Number of events 4 • Adverse events were collected From Start of the Study up to EOS (Week 60)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER