Trial Outcomes & Findings for Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA) (NCT NCT01392326)
NCT ID: NCT01392326
Last Updated: 2016-02-04
Results Overview
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
606 participants
Primary outcome timeframe
Week 24
Results posted on
2016-02-04
Participant Flow
Participant milestones
| Measure |
AIN457 (75 mg)
Secukinumab (75mg)
|
AIN457 (150 mg)
Secukinumab (150 mg)
|
Placebo Match for AIN457 ( 75 and 150 mg)
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Overall Study
STARTED
|
202
|
202
|
202
|
|
Overall Study
COMPLETED
|
155
|
167
|
154
|
|
Overall Study
NOT COMPLETED
|
47
|
35
|
48
|
Reasons for withdrawal
| Measure |
AIN457 (75 mg)
Secukinumab (75mg)
|
AIN457 (150 mg)
Secukinumab (150 mg)
|
Placebo Match for AIN457 ( 75 and 150 mg)
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
15
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
7
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
14
|
10
|
15
|
|
Overall Study
Adverse Event
|
9
|
6
|
11
|
Baseline Characteristics
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Baseline characteristics by cohort
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
552 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
330 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
|
50.5 % participant
|
50.0 % participant
|
17.3 % participant
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
Outcome measures
| Measure |
Group 1
n=108 Participants
Secukinumab (75mg)
|
Group 2
n=108 Participants
Secukinumab (150 mg)
|
Group 3
n=109 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
|
64.8 % participants acheiving goal
|
61.1 % participants acheiving goal
|
8.3 % participants acheiving goal
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
Outcome measures
| Measure |
Group 1
n=108 Participants
Secukinumab (75mg)
|
Group 2
n=108 Participants
Secukinumab (150 mg)
|
Group 3
n=109 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
|
49.1 % of participants acheiving goal
|
45.4 % of participants acheiving goal
|
3.7 % of participants acheiving goal
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: \<math\>DAS-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96\</math\> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
|
-1.67 units on scale
Standard Error 0.085
|
-1.62 units on scale
Standard Error 0.084
|
-0.77 units on scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
|
5.41 units on scale
Standard Error 0.524
|
5.91 units on scale
Standard Error 0.525
|
1.82 units on scale
Standard Error 0.715
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
|
-0.41 units on a scale
Standard Error 0.036
|
-0.40 units on a scale
Standard Error 0.036
|
-0.17 units on a scale
Standard Error 0.047
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set
ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=202 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
|
30.7 % participant
|
34.7 % participant
|
7.4 % participant
|
SECONDARY outcome
Timeframe: Week 24Population: .Full analysis set.
Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Outcome measures
| Measure |
Group 1
n=202 Participants
Secukinumab (75mg)
|
Group 2
n=202 Participants
Secukinumab (150 mg)
|
Group 3
n=404 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
|
0.02 units on a scale
Standard Error 0.22
|
0.13 units on a scale
Standard Error 0.20
|
0.57 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set
Outcome measures
| Measure |
Group 1
n=104 Participants
Secukinumab (75mg)
|
Group 2
n=104 Participants
Secukinumab (150 mg)
|
Group 3
n=116 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
|
43.3 % participants
|
51.9 % participants
|
84.5 % participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis set
Outcome measures
| Measure |
Group 1
n=129 Participants
Secukinumab (75mg)
|
Group 2
n=126 Participants
Secukinumab (150 mg)
|
Group 3
n=102 Participants
Placebo match (for 75 and 150 mg)
|
|---|---|---|---|
|
Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
|
51.2 % participants
|
54.0 % participants
|
87.2 % participants
|
Adverse Events
Any AIN457 75 mg
Serious events: 32 serious events
Other events: 217 other events
Deaths: 0 deaths
Any AIN457 150 mg
Serious events: 51 serious events
Other events: 222 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any AIN457 75 mg
n=292 participants at risk
Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
|
Any AIN457 150 mg
n=295 participants at risk
Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
|
Placebo
n=202 participants at risk
Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
|
|---|---|---|---|
|
Infections and infestations
Prostatitis Escherichia coli
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Rash pustular
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Sepsis
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Septic shock
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Sinusitis
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Urosepsis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Viral infection
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Cardiac disorders
Angina pectoris
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Cardiac disorders
Angina unstable
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/292
|
0.68%
2/295
|
0.50%
1/202
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Cardiac disorders
Palpitations
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Endocrine disorders
Goitre
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Eye disorders
Ocular myasthenia
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Crohn's disease
|
0.34%
1/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Oesophagitis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
General disorders
Impaired healing
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/292
|
0.68%
2/295
|
0.50%
1/202
|
|
General disorders
Peripheral swelling
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
General disorders
Pyrexia
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Abdominal sepsis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Appendiceal abscess
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Cellulitis
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Dengue fever
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Infections and infestations
Erysipelas
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Lung abscess
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Necrotising fasciitis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Infections and infestations
Pneumonia
|
0.68%
2/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
1/292
|
1.4%
4/295
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/292
|
1.4%
4/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Dizziness
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Nervous system disorders
Hemiplegia
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Presyncope
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Nervous system disorders
Thrombotic stroke
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Nervous system disorders
Transient ischaemic attack
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Psychiatric disorders
Depression
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/292
|
0.34%
1/295
|
0.50%
1/202
|
|
Renal and urinary disorders
Renal failure acute
|
0.34%
1/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/292
|
0.34%
1/295
|
0.00%
0/202
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Vascular disorders
Hypertension
|
0.34%
1/292
|
0.00%
0/295
|
0.00%
0/202
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/292
|
0.00%
0/295
|
0.50%
1/202
|
Other adverse events
| Measure |
Any AIN457 75 mg
n=292 participants at risk
Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
|
Any AIN457 150 mg
n=295 participants at risk
Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
|
Placebo
n=202 participants at risk
Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
7/292
|
1.4%
4/295
|
3.0%
6/202
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.1%
6/292
|
1.4%
4/295
|
0.99%
2/202
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
3/292
|
3.4%
10/295
|
0.00%
0/202
|
|
Eye disorders
Dry eye
|
1.4%
4/292
|
2.0%
6/295
|
0.50%
1/202
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.68%
2/292
|
2.0%
6/295
|
0.99%
2/202
|
|
Gastrointestinal disorders
Constipation
|
2.1%
6/292
|
2.7%
8/295
|
0.50%
1/202
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
21/292
|
7.1%
21/295
|
3.0%
6/202
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
7/292
|
4.7%
14/295
|
1.5%
3/202
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
4/292
|
2.0%
6/295
|
0.99%
2/202
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
7/292
|
2.4%
7/295
|
1.5%
3/202
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.7%
5/292
|
3.1%
9/295
|
0.00%
0/202
|
|
Gastrointestinal disorders
Nausea
|
5.5%
16/292
|
3.7%
11/295
|
0.99%
2/202
|
|
Gastrointestinal disorders
Toothache
|
2.4%
7/292
|
0.34%
1/295
|
1.5%
3/202
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
12/292
|
1.4%
4/295
|
0.50%
1/202
|
|
General disorders
Fatigue
|
3.8%
11/292
|
3.1%
9/295
|
2.5%
5/202
|
|
General disorders
Malaise
|
2.1%
6/292
|
0.68%
2/295
|
0.00%
0/202
|
|
General disorders
Oedema peripheral
|
1.4%
4/292
|
2.0%
6/295
|
0.00%
0/202
|
|
General disorders
Pyrexia
|
2.1%
6/292
|
2.4%
7/295
|
0.99%
2/202
|
|
Immune system disorders
Seasonal allergy
|
1.7%
5/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Infections and infestations
Bronchitis
|
4.8%
14/292
|
7.1%
21/295
|
3.0%
6/202
|
|
Infections and infestations
Cellulitis
|
2.1%
6/292
|
1.7%
5/295
|
0.50%
1/202
|
|
Infections and infestations
Conjunctivitis
|
1.7%
5/292
|
3.1%
9/295
|
0.00%
0/202
|
|
Infections and infestations
Gastroenteritis
|
2.7%
8/292
|
6.8%
20/295
|
0.99%
2/202
|
|
Infections and infestations
Influenza
|
4.1%
12/292
|
3.4%
10/295
|
0.99%
2/202
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
5/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Infections and infestations
Nasopharyngitis
|
20.9%
61/292
|
18.3%
54/295
|
5.4%
11/202
|
|
Infections and infestations
Oral herpes
|
2.4%
7/292
|
4.1%
12/295
|
0.99%
2/202
|
|
Infections and infestations
Paronychia
|
1.4%
4/292
|
2.7%
8/295
|
0.00%
0/202
|
|
Infections and infestations
Pharyngitis
|
3.4%
10/292
|
4.7%
14/295
|
0.00%
0/202
|
|
Infections and infestations
Respiratory tract infection
|
0.34%
1/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Infections and infestations
Rhinitis
|
1.4%
4/292
|
2.4%
7/295
|
0.00%
0/202
|
|
Infections and infestations
Sinusitis
|
3.4%
10/292
|
5.4%
16/295
|
2.0%
4/202
|
|
Infections and infestations
Tinea pedis
|
2.1%
6/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Infections and infestations
Tonsillitis
|
2.7%
8/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Infections and infestations
Tooth abscess
|
2.7%
8/292
|
2.7%
8/295
|
0.00%
0/202
|
|
Infections and infestations
Upper respiratory tract infection
|
17.8%
52/292
|
20.3%
60/295
|
5.9%
12/202
|
|
Infections and infestations
Urinary tract infection
|
4.8%
14/292
|
5.8%
17/295
|
0.99%
2/202
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.1%
9/292
|
4.1%
12/295
|
2.5%
5/202
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.34%
1/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
2.1%
6/292
|
0.68%
2/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
4/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Laceration
|
2.7%
8/292
|
3.7%
11/295
|
1.5%
3/202
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
4/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.1%
6/292
|
2.7%
8/295
|
0.50%
1/202
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.0%
3/292
|
2.7%
8/295
|
0.50%
1/202
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
5/292
|
2.4%
7/295
|
2.0%
4/202
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.1%
6/292
|
1.0%
3/295
|
0.50%
1/202
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.4%
10/292
|
4.1%
12/295
|
4.0%
8/202
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.8%
11/292
|
5.1%
15/295
|
2.5%
5/202
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
20/292
|
5.8%
17/295
|
1.5%
3/202
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.34%
1/292
|
2.0%
6/295
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
29/292
|
7.5%
22/295
|
0.99%
2/202
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
6/292
|
1.7%
5/295
|
0.99%
2/202
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
5/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
11/292
|
2.0%
6/295
|
0.99%
2/202
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
5.1%
15/292
|
4.7%
14/295
|
0.99%
2/202
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
3.1%
9/292
|
3.1%
9/295
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.1%
9/292
|
1.4%
4/295
|
0.00%
0/202
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/292
|
2.0%
6/295
|
0.00%
0/202
|
|
Nervous system disorders
Dizziness
|
2.4%
7/292
|
2.4%
7/295
|
0.50%
1/202
|
|
Nervous system disorders
Headache
|
9.2%
27/292
|
8.5%
25/295
|
3.5%
7/202
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
3/292
|
2.7%
8/295
|
0.00%
0/202
|
|
Nervous system disorders
Paraesthesia
|
2.7%
8/292
|
0.34%
1/295
|
0.99%
2/202
|
|
Psychiatric disorders
Anxiety
|
1.0%
3/292
|
2.7%
8/295
|
0.00%
0/202
|
|
Psychiatric disorders
Depression
|
3.8%
11/292
|
2.0%
6/295
|
2.5%
5/202
|
|
Psychiatric disorders
Insomnia
|
2.7%
8/292
|
1.0%
3/295
|
1.5%
3/202
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
14/292
|
5.8%
17/295
|
3.0%
6/202
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
6/292
|
1.0%
3/295
|
0.50%
1/202
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
15/292
|
3.7%
11/295
|
2.0%
4/202
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
3/292
|
2.4%
7/295
|
0.00%
0/202
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
6/292
|
1.0%
3/295
|
1.5%
3/202
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.5%
22/292
|
3.7%
11/295
|
0.50%
1/202
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
8/292
|
2.7%
8/295
|
3.5%
7/202
|
|
Vascular disorders
Hypertension
|
7.2%
21/292
|
6.1%
18/295
|
2.5%
5/202
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
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