Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001427-12 |
Not provided
Not provided
Not provided
The study got terminated based on result from primary endpoint analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab (ACZ885) | Experimental | Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months |
|
| Placebo | Placebo Comparator | Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab (ACZ885) | Drug | Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Vessel Wall Area Ratio of 12 Months to Baseline | Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. | Baseline, 12 months post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events in 12 Months | Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death. | Baseline to 12 months post-dose |
| Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85302 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31277561 | Derived | Russell KS, Yates DP, Kramer CM, Feller A, Mahling P, Colin L, Clough T, Wang T, LaPerna L, Patel A, Lawall H, Shennak MM, Fulmer J, Nikol S, Smith WB, Muller OJ, Ratchford EV, Basson CT. A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease. Vasc Med. 2019 Oct;24(5):414-421. doi: 10.1177/1358863X19859072. Epub 2019 Jul 5. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
Not provided
A total of 38 patients were enrolled into the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab (ACZ885) | Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months |
| FG001 | Placebo | Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo of Canakinumab |
|
Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. |
| Baseline, 12 months post-dose |
| High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline | Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. | Baseline, 12 months post-dose |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60611 | United States |
| Novartis Investigative Site | Lutherville | Maryland | 21093 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43215 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37920 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23294 | United States |
| Novartis Investigative Site | Hamburg | 20099 | Germany |
| Novartis Investigative Site | Hamburg | 22559 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Mainz | 55116 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | Amman | 11941 | Jordan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
safety analysis set: All patients that received any study drug were included in the safety analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab (ACZ885) | Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months |
| BG001 | Placebo | Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Vessel Wall Area Ratio of 12 Months to Baseline | Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. | The pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients who underwent iliac/femoral stenting were removed from all data points that occurred after this procedure in the analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline, 12 months post-dose |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events in 12 Months | Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death. | All patients that received any study drug were included in the safety analysis set. | Posted | Count of Participants | Participants | Baseline to 12 months post-dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline | Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. | The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline, 12 months post-dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline | Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects. | The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline, 12 months post-dose |
|
|
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canakinumab (ACZ885) | Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months | 10 | 18 | 16 | 18 | ||
| EG001 | Placebo | Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months | 10 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mesenteric arterial occlusion | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mesenteric arteriosclerosis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary vascular disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Plasma cell disorder | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oesophageal mucosa erythema | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pancreatic cyst | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Oesophagogastroduodenoscopy abnormal | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Genital pain | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lichen nitidus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
Study was terminated after the third interim analysis based on result from primary outcome analysis.
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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
Not provided
Not provided
Not provided
| Male |
|
|
|
|