Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003701-42 | 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
Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. |
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 | Geel | BEL | 2440 | Belgium | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35305260 | Derived | 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. | |
| 34273904 |
Not provided
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
A total of 1858 patients were screened in this study.
A total of 1660 participants were treated and included in the Safety set.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subpopulation A (Naive) | Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2015 | Mar 21, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 52 weeks |
| Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 52 weeks |
| Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 | PASI is a combined assessment of lesion severity & 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 & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & 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 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. | Week 16, Week 52 |
| Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 | The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health). | Week 16, Week 52 |
| Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 | A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). | Week 16, Week 52 |
| Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 | The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, "Are you able to..." perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change. | Week 16 and Week 52 |
| Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 | Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. | 16 and 52 weeks |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 | Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug. | 16 and 52 weeks |
| Patient Benefit Index (PBI) at Week 16 and Week 52 | The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'. | Week 16 and Week 52 |
| Bruges |
| 8000 |
| Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Seraing | 4100 | Belgium |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Varna | 9010 | Bulgaria |
| Novartis Investigative Site | Ústí nad Labem | Czech Republic | 400 11 | Czechia |
| Novartis Investigative Site | Pilsen | 30460 | Czechia |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Le Mans | Cedex 09 | 72037 | France |
| Novartis Investigative Site | Toulon | Val De Marne | 83800 | France |
| Novartis Investigative Site | Angers | 49933 | France |
| Novartis Investigative Site | Antony | 92160 | France |
| Novartis Investigative Site | Argenteuil | 95107 | France |
| Novartis Investigative Site | Auxerre | 89000 | France |
| Novartis Investigative Site | Bayonne | 64109 | France |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Boulogne-sur-Mer | 62321 | France |
| Novartis Investigative Site | Brest | 29609 | France |
| Novartis Investigative Site | Caen | 14033 | France |
| Novartis Investigative Site | Cannes | 06400 | France |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Dijon | 21000 | France |
| Novartis Investigative Site | Grenoble | France |
| Novartis Investigative Site | La Rochelle | 17019 | France |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Marseille | 13385 | France |
| Novartis Investigative Site | Martigues | 13500 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Nîmes | 30029 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Pringy | 74374 | France |
| Novartis Investigative Site | Quimper | 29000 | France |
| Novartis Investigative Site | Reims | 51100 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Saint-Mandé | 94163 | France |
| Novartis Investigative Site | Saint-Priest-en-Jarez | 42277 | France |
| Novartis Investigative Site | Toulouse | 31400 | France |
| Novartis Investigative Site | Valence | 26953 | France |
| Novartis Investigative Site | Valenciennes | 59322 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novartis Investigative Site | Mannheim | Baden-Wurttemberg | 68305 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 81675 | Germany |
| Novartis Investigative Site | Aachen | 52074 | Germany |
| Novartis Investigative Site | Andernach | 56626 | Germany |
| Novartis Investigative Site | Berlin | 10789 | Germany |
| Novartis Investigative Site | Berlin | 13187 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Berlin | 13507 | Germany |
| Novartis Investigative Site | Berlin | 13597 | Germany |
| Novartis Investigative Site | Berlin | 15831 | Germany |
| Novartis Investigative Site | Bielefeld | 33647 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Bramsche | 49565 | Germany |
| Novartis Investigative Site | Braunschweig | 38114 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Friedrichshafen | 88045 | Germany |
| Novartis Investigative Site | Gelsenkirchen | 45883 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Halle | 06108 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hamburg | 22303 | Germany |
| Novartis Investigative Site | Hamburg | 22391 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Ibbenbueren | 49477 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Ludwigshafen am Rhein | 67063 | Germany |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Osnabrück | 49074 | Germany |
| Novartis Investigative Site | Pommelsbrunn | 91224 | Germany |
| Novartis Investigative Site | Quedlinburg | 06484 | Germany |
| Novartis Investigative Site | Recklinghausen | 45657 | Germany |
| Novartis Investigative Site | Schwerin | 19055 | Germany |
| Novartis Investigative Site | Simmern | 55469 | Germany |
| Novartis Investigative Site | Vechta | 49377 | Germany |
| Novartis Investigative Site | Wiesbaden | 65203 | Germany |
| Novartis Investigative Site | Heraklion Crete | Greece | 711 10 | Greece |
| Novartis Investigative Site | Athens | GR | 115 25 | Greece |
| Novartis Investigative Site | Pátrai | 265 00 | Greece |
| Novartis Investigative Site | Afula | 1834111 | Israel |
| Novartis Investigative Site | Beersheba | 84101 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Kfar Saba | 4428164 | Israel |
| Novartis Investigative Site | Petah Tikva | 4941492 | Israel |
| Novartis Investigative Site | Arezzo | AR | 52100 | Italy |
| Novartis Investigative Site | Bergamo | BG | 24127 | Italy |
| Novartis Investigative Site | San Donato Milanese | MI | 20097 | Italy |
| Novartis Investigative Site | Modena | MO | 41124 | Italy |
| Novartis Investigative Site | Perugia | PG | 06100 | Italy |
| Novartis Investigative Site | Siena | SI | 53100 | Italy |
| Novartis Investigative Site | Varese | VA | 21100 | Italy |
| Novartis Investigative Site | Daugavpils | LVA | LV-5404 | Latvia |
| Novartis Investigative Site | Jelgava | LVA | LV-3001 | Latvia |
| Novartis Investigative Site | Riga | LVA | LV-1003 | Latvia |
| Novartis Investigative Site | Ventspils | LVA | LV-3601 | Latvia |
| Novartis Investigative Site | Riga | 1012 | Latvia |
| Novartis Investigative Site | Riga | LV-1001 | Latvia |
| Novartis Investigative Site | Kaunas | LTU | LT 50161 | Lithuania |
| Novartis Investigative Site | Klaipėda | LTU | 92304 | Lithuania |
| Novartis Investigative Site | Kaunas | 47144 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-07195 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Bydgoszcz | 85-094 | Poland |
| Novartis Investigative Site | Gdansk | 80-546 | Poland |
| Novartis Investigative Site | Kielce | 25-317 | Poland |
| Novartis Investigative Site | Krakow | 31-530 | Poland |
| Novartis Investigative Site | Krakow | 31-913 | Poland |
| Novartis Investigative Site | Lodz | 90-436 | Poland |
| Novartis Investigative Site | Lublin | 20-079 | Poland |
| Novartis Investigative Site | Olsztyn | 10-045 | Poland |
| Novartis Investigative Site | Ossy | 42 624 | Poland |
| Novartis Investigative Site | Poznan | 60 529 | Poland |
| Novartis Investigative Site | Warsaw | 02-507 | Poland |
| Novartis Investigative Site | Warsaw | 04141 | Poland |
| Novartis Investigative Site | Wroclaw | 50-368 | Poland |
| Novartis Investigative Site | Lisbon | 1300-000 | Portugal |
| Novartis Investigative Site | Lisbon | 1400-038 | Portugal |
| Novartis Investigative Site | Lisbon | 1649-035 | Portugal |
| Novartis Investigative Site | Lisbon | 1998-018 | Portugal |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Porto | 4200 319 | Portugal |
| Novartis Investigative Site | Vila Nova de Gaia | 4434 502 | Portugal |
| Novartis Investigative Site | Brasov | 500283 | Romania |
| Novartis Investigative Site | Brasov | 500366 | Romania |
| Novartis Investigative Site | Bucharest | 010825 | Romania |
| Novartis Investigative Site | Craiova | 200642 | Romania |
| Novartis Investigative Site | Iași | 700381 | Romania |
| Novartis Investigative Site | Malacky | Slovak Republic | 90101 | Slovakia |
| Novartis Investigative Site | Bardejov | SVK | 085 01 | Slovakia |
| Novartis Investigative Site | Banská Bystrica | 974 01 | Slovakia |
| Novartis Investigative Site | Bratislava | 825 56 | Slovakia |
| Novartis Investigative Site | Košice | 04011 | Slovakia |
| Novartis Investigative Site | Svidník | 08901 | Slovakia |
| Novartis Investigative Site | Žilina | 01207 | Slovakia |
| Novartis Investigative Site | Ferrol | A Coruna | 15405 | Spain |
| Novartis Investigative Site | Vitoria-Gasteiz | Alava | 01009 | Spain |
| Novartis Investigative Site | Elda | Alicante | 03600 | Spain |
| Novartis Investigative Site | Almería | Andalusia | 04009 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41009 | Spain |
| Novartis Investigative Site | Sabadell | Barcelona | 08208 | Spain |
| Novartis Investigative Site | Barakaldo | Basque Country | 48903 | Spain |
| Novartis Investigative Site | Bilbao | Basque Country | 48013 | Spain |
| Novartis Investigative Site | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Novartis Investigative Site | Ávila | Castille and León | 05004 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Albacete | Castille-La Mancha | 02006 | Spain |
| Novartis Investigative Site | Guadalajara | Castille-La Mancha | 19002 | Spain |
| Novartis Investigative Site | Toledo | Castille-La Mancha | 45071 | Spain |
| Novartis Investigative Site | Lleida | Catalonia | 25198 | Spain |
| Novartis Investigative Site | Tarragona | Catalonia | 43005 | Spain |
| Novartis Investigative Site | Terrassa | Catalonia | 08221 | Spain |
| Novartis Investigative Site | Zamora | Espana | 49022 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Lugo | Galicia | 27003 | Spain |
| Novartis Investigative Site | Ourense | Galicia | 32005 | Spain |
| Novartis Investigative Site | Alcalá de Henares | Madrid | 28805 | Spain |
| Novartis Investigative Site | Aranjuez | Madrid | 28300 | Spain |
| Novartis Investigative Site | Fuenlabrada | Madrid | 28942 | Spain |
| Novartis Investigative Site | Getafe | Madrid | 28905 | Spain |
| Novartis Investigative Site | Leganés | Madrid | 28911 | Spain |
| Novartis Investigative Site | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Novartis Investigative Site | Móstoles | Madrid, Communidad de | 28933 | Spain |
| Novartis Investigative Site | Vigo | Pontevedra | 36200 | Spain |
| Novartis Investigative Site | Breña Alta | Santa Cruz De Tenerife | 38712 | Spain |
| Novartis Investigative Site | Talavera de la Reina | Toledo | 45600 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03550 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46017 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Barcelona | 08029 | Spain |
| Novartis Investigative Site | Burgos | 09006 | Spain |
| Novartis Investigative Site | Granada | 18016 | Spain |
| Novartis Investigative Site | Granollers | 08402 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Penzance | Cornwall | TR19 7HX | United Kingdom |
| Novartis Investigative Site | Harlow | Essex | CM20 1QX | United Kingdom |
| Novartis Investigative Site | Rothwell | GBR | NN14 6JQ | United Kingdom |
| Novartis Investigative Site | Burbage | Leicester | LE10 2SE | United Kingdom |
| Novartis Investigative Site | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Novartis Investigative Site | Bury Saint Edmonds | Suffolk | IP33 2QZ | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD5 0NA | United Kingdom |
| Novartis Investigative Site | Bath | BA2 3HT | United Kingdom |
| Novartis Investigative Site | Bristol | BS48 1BZ | United Kingdom |
| Novartis Investigative Site | Chippenham | SN14 6GT | United Kingdom |
| Novartis Investigative Site | Devon | EX8 2JF | United Kingdom |
| Novartis Investigative Site | Durham | DH1 5TW | United Kingdom |
| Novartis Investigative Site | East Sussex | BN2 5BE | United Kingdom |
| Novartis Investigative Site | Exeter | EX2 5DW | United Kingdom |
| Novartis Investigative Site | Lancaster | LA1 4RP | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Middlesex | TW7 6AF | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Novartis Investigative Site | Watford | WD25 7NL | United Kingdom |
| Novartis Investigative Site | Wellingborough | NN8 4RW | United Kingdom |
| da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31. |
| FG001 |
| Subpopulation B (Non-biologic) |
Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| FG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety set: The Safety set included all patients who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subpopulation A (Naive) | Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment. |
| BG001 | Subpopulation B (Non-biologic) | Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| BG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| 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 | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 16 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 | PASI is a combined assessment of lesion severity & 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 & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & 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 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 | The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health). | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Week 16, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 | A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Week 16, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 | The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, "Are you able to..." perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change. | Full Analysis set - subset of patients with psoriatic arthritis at baseline: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Week 16 and Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 | Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | 16 and 52 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 | Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | 16 and 52 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient Benefit Index (PBI) at Week 16 and Week 52 | The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'. | Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | scores on a scale | Week 16 and Week 52 |
|
All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit for up to 52 weeks.
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 | Subpopulation A (Naive) | Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment. | 0 | 663 | 43 | 663 | 450 | 663 |
| EG001 | Subpopulation B (Non-biologic) | Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. | 0 | 673 | 44 | 673 | 474 | 673 |
| EG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. | 1 | 324 | 32 | 324 | 203 | 324 |
| EG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined | 1 | 1,660 | 119 | 1,660 | 1,127 | 1,660 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pupils unequal | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Type 3 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | 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 |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Seborrhoeic keratosis | 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 |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vocal cord leukoplakia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erythema multiforme | 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 |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypovolaemic shock | 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 |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | 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 |
| |
| Tinea pedis | 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary 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 |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intertrigo | 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 |
| |
| Urticaria | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2017 | Mar 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| OG001 | Subpopulation B (Non-biologic) | Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| Subpopulation B (Non-biologic) |
Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| Subpopulation C (Biologic) |
Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| OG001 | Subpopulation B (Non-biologic) | Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| OG001 |
| Subpopulation B (Non-biologic) |
Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
| OG001 | Subpopulation B (Non-biologic) | Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment. |
| OG002 | Subpopulation C (Biologic) | Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment. |
| OG003 | All Participants | Participants from all 3 subpopulations: Subpopulation A B & C combined |
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|