Trial Outcomes & Findings for Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis (NCT NCT03350815)
NCT ID: NCT03350815
Last Updated: 2022-04-29
Results Overview
Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
322 participants
Primary outcome timeframe
Week 52
Results posted on
2022-04-29
Participant Flow
322 participants were enrolled at 65 sites in the United States
Of 435 patients screened in the study, 322 (74.0%) completed the Screening phase.
Participant milestones
| Measure |
Period 1: Secukinumab 150 mg
Participants received Secukinumab 150 mg in Period 1
|
Period 2: Secukinumab 300 mg (Period 1 Inadequate Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and randomized to receive Secukinumab 300 mg in Period 2
|
Secukinumab 150 mg (Period 1 Inadequate Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and continued with Secukinumab 150 mg in Period 2
|
Secukinumab 150 mg (Period 1 Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as responders and continued with Secukinumab 150 mg in Period 2
|
|---|---|---|---|---|
|
Period 1
STARTED
|
322
|
0
|
0
|
0
|
|
Period 1
Non-responders
|
50
|
0
|
0
|
0
|
|
Period 1
Inadequate Responders
|
207
|
0
|
0
|
0
|
|
Period 1
Responders
|
22
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
279
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
43
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
102
|
105
|
22
|
|
Period 2
COMPLETED
|
0
|
86
|
88
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
16
|
17
|
0
|
Reasons for withdrawal
| Measure |
Period 1: Secukinumab 150 mg
Participants received Secukinumab 150 mg in Period 1
|
Period 2: Secukinumab 300 mg (Period 1 Inadequate Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and randomized to receive Secukinumab 300 mg in Period 2
|
Secukinumab 150 mg (Period 1 Inadequate Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as inadequate responders and continued with Secukinumab 150 mg in Period 2
|
Secukinumab 150 mg (Period 1 Responders)
Participants received Secukinumab 150 mg in Period 1 were assessed as responders and continued with Secukinumab 150 mg in Period 2
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
10
|
0
|
0
|
0
|
|
Period 1
Technical problems
|
1
|
0
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
3
|
0
|
0
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
8
|
0
|
0
|
0
|
|
Period 1
Lack of Efficacy
|
15
|
0
|
0
|
0
|
|
Period 1
Non-compliance with study treatment
|
2
|
0
|
0
|
0
|
|
Period 1
Protocol Violation
|
3
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
3
|
5
|
0
|
|
Period 2
Technical problem
|
0
|
1
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
3
|
3
|
0
|
|
Period 2
Physician Decision
|
0
|
0
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
3
|
4
|
0
|
|
Period 2
Lack of Efficacy
|
0
|
6
|
2
|
0
|
|
Period 2
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Period 2
New therapy for study indication
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Secukinumab 150 mg - 150 mg
n=322 Participants
AIN457 150 mg - 150 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
283 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=99 Participants
|
|
Age, Continuous
|
48.02 Mean
STANDARD_DEVIATION 13.692 • n=99 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
284 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization. According to intent-to-treat principle, patients were analyzed according to the treatment they were assigned to during the randomization procedure.
Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS (defined as a patient with inadequte respinse at week 16) for patients with valid assessment for this endpoint.
A reduction from baseline in ASDAS score of ≥1.1 was considered a clinically important improvement in disease activity in Ankylosing Spondylitis. In this study, ASDAS is used to estimate the difference in response between 150mg and 300mg of secukinumab. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) wias utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS for patients with valid assessment for this endpoint.
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=83 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=85 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
0.18 Score on a scale
Standard Error 0.191
|
-0.05 Score on a scale
Standard Error 0.188
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS for patients with valid assessment for this endpoint.
BASDAI-50 represents a change from baseline (improvement) of at least 50% in BASDAI score. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50)
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: FAS for patients with valid assessment for this endpoint.
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS20 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defines as ≥20% worsening and absolute worsening of at last 1 on a 0-to-10 scale) in the potential remaining domain.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: FAS for patients with valid assessment for this endpoint.
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS40 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
The Proportion of Participants Who Achieved an ASAS 40 Response
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: FAS for patients with valid assessment for this endpoint.
The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 0-10. In this study, ASAS partial remission is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=102 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=105 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
The Proportion of Patients Who Achieved an ASAS Partial Remission
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS for patients with valid assessment for this endpoint.
The ASAS-HI is a self-administered questionnaire and measures functioning and health over 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. Patients score each item as "I agree" and "I do not agree". In this study, ASAS-HI is used to estimate the difference in response between 150mg and 300mg of secukinumab. Lower score indicating a better health status
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=83 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=85 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
Change in ASAS - Health Index Over Time
|
0.51 scores on a scale
Standard Error 0.320
|
0.38 scores on a scale
Standard Error 0.315
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS for patients with valid assessment for this endpoint.
Fatigue was assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
Outcome measures
| Measure |
Secukinumab 150 mg - 300 mg (IR)
n=83 Participants
AIN457 150 mg - 300 mg
|
Secukinumab 150 mg - 150 mg (IR)
n=85 Participants
AIN457 150 mg - 150 mg (IR)
|
|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time
|
-1.93 Score
Standard Error 0.954
|
-0.92 Score
Standard Error 0.938
|
Adverse Events
Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment Period 1 Secukinumab 150 mg
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
n=22 participants at risk
Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
|
Treatment Period 1 Secukinumab 150 mg
n=322 participants at risk
Treatment Period 1 Secukinumab 150 mg
|
Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
n=101 participants at risk
Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
|
Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
n=105 participants at risk
Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.95%
1/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.95%
1/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.95%
1/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.99%
1/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.00%
0/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
Other adverse events
| Measure |
Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
n=22 participants at risk
Treatment Period 2 Secukinumab 150 mg - 150 mg (R)
|
Treatment Period 1 Secukinumab 150 mg
n=322 participants at risk
Treatment Period 1 Secukinumab 150 mg
|
Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
n=101 participants at risk
Treatment Period 2 Secukinumab 150 mg - 300 mg (IR)
|
Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
n=105 participants at risk
Treatment Period 2 Secukinumab 150 mg - 150 mg (IR)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
5.6%
18/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
6.9%
7/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
2.9%
3/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
4.7%
15/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
5.9%
6/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
7.6%
8/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Investigations
SARS-CoV-2 test negative
|
9.1%
2/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.62%
2/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
6.9%
7/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
7.6%
8/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
9.1%
2/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.31%
1/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
5.0%
5/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
0.95%
1/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
4.7%
15/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
5.9%
6/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
9.5%
10/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
1.9%
6/322 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
4.0%
4/101 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
3.8%
4/105 • AEs were collected from first dose of study treatment until end of study treatment at week 52
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to 52 weeks
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER