AzTrials
AzTrials

Plaque PsoriasisPhase 4PROSENCT02752776

A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

A Phase 4 study testing Secukinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 215 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,660 participants
Where
215 sitesin 17 countries
Study dates
17 Mar 2016to 28 Mar 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged at least 18 years at time of Screening.
  • Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
  • Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Who cannot join

  • Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
  • Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless they use effective contraception

Trial locations and contacts

215 sites in 17 countries.

215 sites in 17 countries

Spain45 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Albacete, Castille-La Mancha, 02006

  • Novartis Investigative Site

    Alcalá de Henares, Madrid, 28805

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Alicante, Valencia, 03550

  • Novartis Investigative Site

    Almería, Andalusia, 04009

  • Novartis Investigative Site

    Aranjuez, Madrid, 28300

  • Novartis Investigative Site

    Ávila, Castille and León, 05004

  • Novartis Investigative Site

    Barakaldo, Basque Country, 48903

  • Novartis Investigative Site

    Barcelona, 08029

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Breña Alta, Santa Cruz De Tenerife, 38712

  • Novartis Investigative Site

    Burgos, 09006

  • Novartis Investigative Site

    Elda, Alicante, 03600

  • Novartis Investigative Site

    Ferrol, A Coruna, 15405

  • Novartis Investigative Site

    Fuenlabrada, Madrid, 28942

  • Novartis Investigative Site

    Getafe, Madrid, 28905

  • Novartis Investigative Site

    Granada, 18016

  • Novartis Investigative Site

    Granollers, 08402

  • Novartis Investigative Site

    Guadalajara, Castille-La Mancha, 19002

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407

  • Novartis Investigative Site

    Leganés, Madrid, 28911

  • Novartis Investigative Site

    Lleida, Catalonia, 25198

  • Novartis Investigative Site

    Lugo, Galicia, 27003

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Móstoles, Madrid, Communidad de, 28933

  • Novartis Investigative Site

    Ourense, Galicia, 32005

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Talavera de la Reina, Toledo, 45600

  • Novartis Investigative Site

    Tarragona, Catalonia, 43005

  • Novartis Investigative Site

    Terrassa, Catalonia, 08221

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Torrejón de Ardoz, Madrid, 28850

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46017

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Valladolid, Castille and León, 47011

  • Novartis Investigative Site

    Vigo, Pontevedra, 36200

  • Novartis Investigative Site

    Vitoria-Gasteiz, Alava, 01009

  • Novartis Investigative Site

    Zamora, Espana, 49022

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Germany42 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Andernach, 56626

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 13597

  • Novartis Investigative Site

    Berlin, 15831

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Bramsche, 49565

  • Novartis Investigative Site

    Braunschweig, 38114

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Friedrichshafen, 88045

  • Novartis Investigative Site

    Gelsenkirchen, 45883

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22303

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Ibbenbueren, 49477

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Ludwigshafen am Rhein, 67063

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Pommelsbrunn, 91224

  • Novartis Investigative Site

    Quedlinburg, 06484

  • Novartis Investigative Site

    Recklinghausen, 45657

  • Novartis Investigative Site

    Schwerin, 19055

  • Novartis Investigative Site

    Simmern, 55469

  • Novartis Investigative Site

    Vechta, 49377

  • Novartis Investigative Site

    Wiesbaden, 65203

Other trials in Germany

France33 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Antony, 92160

  • Novartis Investigative Site

    Argenteuil, 95107

  • Novartis Investigative Site

    Auxerre, 89000

  • Novartis Investigative Site

    Bayonne, 64109

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Boulogne-sur-Mer, 62321

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    Caen, 14033

  • Novartis Investigative Site

    Cannes, 06400

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Dijon, 21000

  • Novartis Investigative Site

    Grenoble

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    Le Mans, Cedex 09, 72037

  • Novartis Investigative Site

    Lille, 59000

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Martigues, 13500

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Pringy, 74374

  • Novartis Investigative Site

    Quimper, 29000

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Saint-Mandé, 94163

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42277

  • Novartis Investigative Site

    Toulon, Val De Marne, 83800

  • Novartis Investigative Site

    Toulouse, 31400

  • Novartis Investigative Site

    Valence, 26953

  • Novartis Investigative Site

    Valenciennes, 59322

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom21 sites

  • Novartis Investigative Site

    Bath, BA2 3HT

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD5 0NA

  • Novartis Investigative Site

    Bristol, BS48 1BZ

  • Novartis Investigative Site

    Burbage, Leicester, LE10 2SE

  • Novartis Investigative Site

    Bury Saint Edmonds, Suffolk, IP33 2QZ

  • Novartis Investigative Site

    Chippenham, SN14 6GT

  • Novartis Investigative Site

    Devon, EX8 2JF

  • Novartis Investigative Site

    Durham, DH1 5TW

  • Novartis Investigative Site

    East Sussex, BN2 5BE

  • Novartis Investigative Site

    Exeter, EX2 5DW

  • Novartis Investigative Site

    Harlow, Essex, CM20 1QX

  • Novartis Investigative Site

    Harrow, Middlesex, HA1 3UJ

  • Novartis Investigative Site

    Lancaster, LA1 4RP

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Middlesex, TW7 6AF

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP

  • Novartis Investigative Site

    Penzance, Cornwall, TR19 7HX

  • Novartis Investigative Site

    Rothwell, GBR, NN14 6JQ

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG

  • Novartis Investigative Site

    Watford, WD25 7NL

  • Novartis Investigative Site

    Wellingborough, NN8 4RW

Other trials in United Kingdom

Poland13 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-094

  • Novartis Investigative Site

    Gdansk, 80-546

  • Novartis Investigative Site

    Kielce, 25-317

  • Novartis Investigative Site

    Krakow, 31-530

  • Novartis Investigative Site

    Krakow, 31-913

  • Novartis Investigative Site

    Lodz, 90-436

  • Novartis Investigative Site

    Lublin, 20-079

  • Novartis Investigative Site

    Olsztyn, 10-045

  • Novartis Investigative Site

    Ossy, 42 624

  • Novartis Investigative Site

    Poznan, 60 529

  • Novartis Investigative Site

    Warsaw, 02-507

  • Novartis Investigative Site

    Warsaw, 04141

  • Novartis Investigative Site

    Wroclaw, 50-368

Other trials in Poland

Italy7 sites

  • Novartis Investigative Site

    Arezzo, AR, 52100

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Perugia, PG, 06100

  • Novartis Investigative Site

    San Donato Milanese, MI, 20097

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Varese, VA, 21100

Other trials in Italy

Portugal7 sites

  • Novartis Investigative Site

    Lisbon, 1300-000

  • Novartis Investigative Site

    Lisbon, 1400-038

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Lisbon, 1998-018

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Porto, 4200 319

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

Slovakia7 sites

  • Novartis Investigative Site

    Banská Bystrica, 974 01

  • Novartis Investigative Site

    Bardejov, SVK, 085 01

  • Novartis Investigative Site

    Bratislava, 825 56

  • Novartis Investigative Site

    Košice, 04011

  • Novartis Investigative Site

    Malacky, Slovak Republic, 90101

  • Novartis Investigative Site

    Svidník, 08901

  • Novartis Investigative Site

    Žilina, 01207

Other trials in Slovakia

Latvia6 sites

  • Novartis Investigative Site

    Daugavpils, LVA, LV-5404

  • Novartis Investigative Site

    Jelgava, LVA, LV-3001

  • Novartis Investigative Site

    Riga, LVA, LV-1003

  • Novartis Investigative Site

    Riga, 1012

  • Novartis Investigative Site

    Riga, LV-1001

  • Novartis Investigative Site

    Ventspils, LVA, LV-3601

Other trials in Latvia

Bulgaria5 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Stara Zagora, 6000

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Israel5 sites

  • Novartis Investigative Site

    Afula, 1834111

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Petah Tikva, 4941492

Other trials in Israel

Lithuania5 sites

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161

  • Novartis Investigative Site

    Kaunas, 47144

  • Novartis Investigative Site

    Klaipėda, LTU, 92304

  • Novartis Investigative Site

    Vilnius, LT-07195

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Romania5 sites

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Brasov, 500366

  • Novartis Investigative Site

    Bucharest, 010825

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Iași, 700381

Other trials in Romania

Belgium4 sites

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Geel, BEL, 2440

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Seraing, 4100

Other trials in Belgium

Czechia4 sites

  • Novartis Investigative Site

    Pilsen, 30460

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 150 06

  • Novartis Investigative Site

    Ústí nad Labem, Czech Republic, 400 11

Other trials in Czechia

Estonia3 sites

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Greece3 sites

  • Novartis Investigative Site

    Athens, GR, 115 25

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Pátrai, 265 00

Other trials in Greece

About this study

Official title: An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

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.

Being tested
Secukinumab
Keywords
secukinumab, AIN457, Moderate to severe plaque psoriasis, immune-mediated systemic disease, scaly patches, papules, plaques, itching
Medical subject headings
Plaque, Amyloid, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabDrug

    Also called AIN457

    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).

Study groups in NCT02752776
Study groupRoleWhat they receive
SecukinumabExperimentalAll 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.
Receives: Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 52 weeks

  2. 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.

    Measured: 52 weeks

  3. 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.

    Measured: Week 16, Week 52

  4. 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).

    Measured: Week 16, Week 52

  5. 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").

    Measured: Week 16, Week 52

  6. 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.

    Measured: Week 16 and Week 52

  7. 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.

    Measured: 16 and 52 weeks

  8. 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.

    Measured: 16 and 52 weeks

  9. 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'.

    Measured: Week 16 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study start17 Mar 2016
  3. Primary completion28 Mar 2018
  4. Study completion28 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752776
Sponsor's protocol ID
CAIN457A3401
Other IDs
2015-003701-42, 2015
Acronym
PROSE
Status last verified
Aug 2019
First submitted
10 Feb 2016
Last updated
25 Sep 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 35305260

  • 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.

    PubMed 34273904

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 215 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in Spain, Germany, France, United Kingdom, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752776, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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