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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003434-32 | EudraCT Number |
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This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 300 mg | Experimental | patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive |
|
| Ustekinumab | Active Comparator | patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 300 mg | Drug |
|
| |
| ustekinumab 45/90 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35205 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36334236 | Derived | Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5. | |
| 35305260 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Of the 676 patients who were randomized to the study, 571 patients completed the study (286 patients (84.9%) in the secukinumab group and 285 patients (84.1%) in the ustekinumab group. Efficacy Data up to 52 weeks and Safety Data included up to 104 weeks
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 300 mg | patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive |
| FG001 | Ustekinumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| placebo secukinumab | Drug | Placebo |
|
| Week 4 |
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52 | Week 52 |
| Mobile |
| Alabama |
| 36608 |
| United States |
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| Novartis Investigative Site | Salford | Manchester | M6 8HD | United Kingdom |
| Novartis Investigative Site | Dundee | Perthshire | DD1 9SY | United Kingdom |
| Novartis Investigative Site | Redhill | Surrey | RH1 5RH | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD5 0NA | United Kingdom |
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| Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19. |
| 34870789 | Derived | Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6. |
| 30972746 | Derived | Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17. |
| 26092291 | Derived | Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17. |
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive |
| Full Analysis Set (FAS) |
|
| Safety Set (SF) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 300 mg | patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive |
| BG001 | Ustekinumab | patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive |
| 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 | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | Posted | Number | Percentage of Participants | Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | Posted | Number | percentage of participants | Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | Posted | Number | percentage of participants | Week 52 |
|
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIN457 300 mg | patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive | 41 | 335 | 270 | 335 | ||
| EG001 | Ustekinumab | patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive | 32 | 336 | 246 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VENTRICULAR FAILURE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAMARTOMA | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TYMPANIC MEMBRANE PERFORATION | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OCULAR HYPERTENSION | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VITREOUS ADHESIONS | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CIRRHOSIS ALCOHOLIC | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NON-ALCOHOLIC FATTY LIVER | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| NASAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PILONIDAL CYST | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| SCROTAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| INJECTION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| POST CONCUSSION SYNDROME | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| BRAIN NEOPLASM BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| FIBROADENOMA OF BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMANGIOMA OF LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| KERATOACANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CAROTID ARTERY DISEASE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FACIAL SPASM | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| POSTICTAL PARALYSIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ALVEOLITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| LICHENIFICATION | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PEMPHIGOID | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SEGMENTED HYALINISING VASCULITIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| AORTIC ANEURYSM RUPTURE | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| TINEA PEDIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SEBORRHOEIC DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
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 |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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