Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003849-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab 150 mg | Experimental | Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
| Secukinumab 150 mg No load | Experimental | Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
| Placebo | Placebo Comparator | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With American College of Rheumatology 20 (ACR20) Response | The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16 | DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity. n: Number of subjects with measures at both baseline and the corresponding post baseline visit. | week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 | Mesa | Arizona | 85202 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38446397 | Derived | Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6. | |
| 34795065 |
| Label | URL |
|---|---|
| Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format. | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Patients were randomized 1:1:1.
There were 341 patients originally randomized to one of 2 trearment groups. Seven placebo patients discontinued before week 16 and therefore not switched to treatment. Only 334 patients received secukinumab treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 150 mg | Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug. |
|
| Psoriatic Area and Severity Index 75 (PASI75) | PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. PASI75 response using non-responder imputation and rescue penalty up to Week 16 | 16 weeks |
| Short Form Health Survey Physical Component Score (SF-36-PCS) | SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. | 16 weeks |
| Number of Participants With American College of Rheumatology 50 (ACR50) | The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16 | 16 weeks |
| Number of Participants With American College of Rheumatology 20 (ACR20) Response | The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo | 4 weeks |
| Upland |
| California |
| 91786 |
| United States |
| Novartis Investigative Site | Denver | Colorado | 80230 | United States |
| Novartis Investigative Site | Palm Harbor | Florida | 34684 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34239 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61602 | United States |
| Novartis Investigative Site | Shreveport | Louisiana | 71101 | United States |
| Novartis Investigative Site | Saint Clair Shores | Michigan | 48081 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63117 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | United States |
| Novartis Investigative Site | Albany | New York | 12206 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29460 | United States |
| Novartis Investigative Site | Greenville | South Carolina | 29601 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75150 | United States |
| Novartis Investigative Site | Burlington | Vermont | 05401 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Seattle | Washington | 98122 | United States |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Maroochydore | Queensland | 4558 | Australia |
| Novartis Investigative Site | Hobart | Tasmania | 7000 | Australia |
| Novartis Investigative Site | Malvern East | Victoria | 3145 | Australia |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Yvoir | 5530 | Belgium |
| Novartis Investigative Site | Plovdiv | 4000 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Victoria | British Columbia | V8V 3M9 | Canada |
| Novartis Investigative Site | Winnipeg | Manitoba | R3A 1M1 | Canada |
| Novartis Investigative Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Novartis Investigative Site | Bruntál | Czech Republic | 792 01 | Czechia |
| Novartis Investigative Site | Hlučín | Czech Republic | 748 01 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 128 50 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 140 00 | Czechia |
| Novartis Investigative Site | Uherské Hradiště | Czech Republic | 686 01 | Czechia |
| Novartis Investigative Site | Le Mans | 72037 | France |
| Novartis Investigative Site | Montpellier | 34195 | France |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt am Main | 60528 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 20095 | Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Magdeburg | 39110 | Germany |
| Novartis Investigative Site | Nienburg | 31582 | Germany |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Bologna | 40138 | Italy |
| Novartis Investigative Site | Bialystok | 15-461 | Poland |
| Novartis Investigative Site | Dopiewo | 62 069 | Poland |
| Novartis Investigative Site | Elblag | 82-300 | Poland |
| Novartis Investigative Site | Lodz | 90-265 | Poland |
| Novartis Investigative Site | Poznan | 60-218 | Poland |
| Novartis Investigative Site | Poznan | 61 113 | Poland |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 190068 | Russia |
| Novartis Investigative Site | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620028 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620035 | Russia |
| Novartis Investigative Site | Stockholm | SE-17176 | Sweden |
| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
| Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845. |
| 31228101 | Derived | Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21. |
| Secukinumab 150 mg No Load |
Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| FG002 | Placebo | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| COMPLETED | Completed Week 104 |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 150 mg | Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| BG001 | Secukinumab 150 mg No Load | Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| BG002 | Placebo | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| BG003 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Number of Participants With American College of Rheumatology 20 (ACR20) Response | The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. | Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16 | DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity. n: Number of subjects with measures at both baseline and the corresponding post baseline visit. | Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned. | Posted | Least Squares Mean | Standard Error | scores | week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Psoriatic Area and Severity Index 75 (PASI75) | PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. PASI75 response using non-responder imputation and rescue penalty up to Week 16 | The psoriasis subset included all full analysis set (FAS) patients who had ≥3% of the body surface area (BSA) affected by psoriatic skin involvement at baseline. | Posted | Count of Participants | Participants | 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Short Form Health Survey Physical Component Score (SF-36-PCS) | SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. | Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned. | Posted | Least Squares Mean | Standard Error | scores on a scale | 16 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With American College of Rheumatology 50 (ACR50) | The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16 | Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned. | Posted | Count of Participants | Participants | 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With American College of Rheumatology 20 (ACR20) Response | The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo | Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned. | Posted | Count of Participants | Participants | 4 weeks |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112
Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
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 | Any AIN457 150 mg | Any AIN457 150 mg | 1 | 334 | 47 | 334 | 252 | 334 |
| EG001 | Any AIN457 300 mg | Any AIN457 300 mg | 1 | 136 | 12 | 136 | 89 | 136 |
| EG002 | Any AIN457 | Any AIN457 | 2 | 334 | 59 | 334 | 267 | 334 |
| EG003 | Placebo | Placebo | 1 | 114 | 5 | 114 | 61 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Immunosuppression | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Undifferentiated sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cervicogenic headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Device fastener issue | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ureteric compression | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | +1 (862) 778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Male |
|
| White |
|
| Odds Ratio (OR) |
| 3.24 |
| 2-Sided |
| 95 |
| 1.76 |
| 5.97 |
| Superiority |
Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
|
| OG002 | Placebo | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
|
Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| OG002 | Placebo Non-responder | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
|
| OG002 | Placebo | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
|
| OG002 | Placebo | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
|
|