PROSE: A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02752776
Collaborator
(none)
1,660
215
1
24.3
7.7
0.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1660 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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.
Actual Study Start Date
:
Mar 17, 2016
Actual Primary Completion Date
:
Mar 28, 2018
Actual Study Completion Date
:
Mar 28, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Secukinumab 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. |
Drug: Secukinumab
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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 [16 weeks]
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.
Secondary Outcome Measures
- Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 [52 weeks]
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.
- Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 [52 weeks]
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.
- Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 [Week 16, Week 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.
- Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 [Week 16, 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).
- Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 [Week 16, 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").
- Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 [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.
- Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 [16 and 52 weeks]
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.
- Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 [16 and 52 weeks]
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.
- Patient Benefit Index (PBI) at Week 16 and Week 52 [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'.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Geel | BEL | Belgium | 2440 |
| 2 | Novartis Investigative Site | Brugge | Belgium | 8000 | |
| 3 | Novartis Investigative Site | Gent | Belgium | 9000 | |
| 4 | Novartis Investigative Site | Seraing | Belgium | 4100 | |
| 5 | Novartis Investigative Site | Pleven | Bulgaria | 5800 | |
| 6 | Novartis Investigative Site | Sofia | Bulgaria | 1407 | |
| 7 | Novartis Investigative Site | Sofia | Bulgaria | 1431 | |
| 8 | Novartis Investigative Site | Stara Zagora | Bulgaria | 6000 | |
| 9 | Novartis Investigative Site | Varna | Bulgaria | 9010 | |
| 10 | Novartis Investigative Site | Usti nad Labem | Czech Republic | Czechia | 400 11 |
| 11 | Novartis Investigative Site | Plzen | Czechia | 30460 | |
| 12 | Novartis Investigative Site | Praha 5 | Czechia | 150 06 | |
| 13 | Novartis Investigative Site | Praha | Czechia | 12808 | |
| 14 | Novartis Investigative Site | Tallinn | Estonia | 10138 | |
| 15 | Novartis Investigative Site | Tallinn | Estonia | 13419 | |
| 16 | Novartis Investigative Site | Tartu | Estonia | 51014 | |
| 17 | Novartis Investigative Site | Le Mans | Cedex 09 | France | 72037 |
| 18 | Novartis Investigative Site | Toulon Cedex 9 | Val De Marne | France | 83800 |
| 19 | Novartis Investigative Site | Angers cedex 09 | France | 49933 | |
| 20 | Novartis Investigative Site | Antony | France | 92160 | |
| 21 | Novartis Investigative Site | Argenteuil | France | 95107 | |
| 22 | Novartis Investigative Site | Auxerre | France | 89000 | |
| 23 | Novartis Investigative Site | Bayonne | France | 64109 | |
| 24 | Novartis Investigative Site | Bordeaux | France | 33076 | |
| 25 | Novartis Investigative Site | Boulogne-sur-Mer | France | 62321 | |
| 26 | Novartis Investigative Site | Brest | France | 29609 | |
| 27 | Novartis Investigative Site | Caen | France | 14033 | |
| 28 | Novartis Investigative Site | Cannes | France | 06400 | |
| 29 | Novartis Investigative Site | Clermont Ferrand cedex 1 | France | 63003 | |
| 30 | Novartis Investigative Site | Dijon | France | 21000 | |
| 31 | Novartis Investigative Site | Grenoble Cedex | France | ||
| 32 | Novartis Investigative Site | La Rochelle | France | 17019 | |
| 33 | Novartis Investigative Site | Lille | France | 59000 | |
| 34 | Novartis Investigative Site | Marseille cedex 05 | France | 13385 | |
| 35 | Novartis Investigative Site | Martigues | France | 13500 | |
| 36 | Novartis Investigative Site | Montpellier cedex 5 | France | 34295 | |
| 37 | Novartis Investigative Site | Nice | France | 06202 | |
| 38 | Novartis Investigative Site | Nimes | France | 30029 | |
| 39 | Novartis Investigative Site | Pierre Benite Cedex | France | 69495 | |
| 40 | Novartis Investigative Site | Pringy cedex | France | 74374 | |
| 41 | Novartis Investigative Site | Quimper | France | 29000 | |
| 42 | Novartis Investigative Site | Reims | France | 51100 | |
| 43 | Novartis Investigative Site | Rouen Cedex | France | 76031 | |
| 44 | Novartis Investigative Site | Saint Mande | France | 94163 | |
| 45 | Novartis Investigative Site | St Priest en Jarez Cedex | France | 42277 | |
| 46 | Novartis Investigative Site | Toulouse Cedex | France | 31400 | |
| 47 | Novartis Investigative Site | Valence Cedex 9 | France | 26953 | |
| 48 | Novartis Investigative Site | Valenciennes Cedex | France | 59322 | |
| 49 | Novartis Investigative Site | Vandoeuvre Les Nancy | France | 54511 | |
| 50 | Novartis Investigative Site | Mannheim | Baden-Wuerttemberg | Germany | 68305 |
| 51 | Novartis Investigative Site | Muenchen | Bayern | Germany | 81675 |
| 52 | Novartis Investigative Site | Aachen | Germany | 52074 | |
| 53 | Novartis Investigative Site | Andernach | Germany | 56626 | |
| 54 | Novartis Investigative Site | Berlin | Germany | 10789 | |
| 55 | Novartis Investigative Site | Berlin | Germany | 13187 | |
| 56 | Novartis Investigative Site | Berlin | Germany | 13353 | |
| 57 | Novartis Investigative Site | Berlin | Germany | 13507 | |
| 58 | Novartis Investigative Site | Berlin | Germany | 13597 | |
| 59 | Novartis Investigative Site | Berlin | Germany | 15831 | |
| 60 | Novartis Investigative Site | Bielefeld | Germany | 33647 | |
| 61 | Novartis Investigative Site | Bonn | Germany | 53105 | |
| 62 | Novartis Investigative Site | Bramsche | Germany | 49565 | |
| 63 | Novartis Investigative Site | Braunschweig | Germany | 38114 | |
| 64 | Novartis Investigative Site | Erlangen | Germany | 91054 | |
| 65 | Novartis Investigative Site | Frankfurt | Germany | 60590 | |
| 66 | Novartis Investigative Site | Freiburg | Germany | 79106 | |
| 67 | Novartis Investigative Site | Friedrichshafen | Germany | 88045 | |
| 68 | Novartis Investigative Site | Gelsenkirchen | Germany | 45883 | |
| 69 | Novartis Investigative Site | Gera | Germany | 07548 | |
| 70 | Novartis Investigative Site | Halle | Germany | 06108 | |
| 71 | Novartis Investigative Site | Hamburg | Germany | 20246 | |
| 72 | Novartis Investigative Site | Hamburg | Germany | 20354 | |
| 73 | Novartis Investigative Site | Hamburg | Germany | 22303 | |
| 74 | Novartis Investigative Site | Hamburg | Germany | 22391 | |
| 75 | Novartis Investigative Site | Hannover | Germany | 30625 | |
| 76 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
| 77 | Novartis Investigative Site | Ibbenbueren | Germany | 49477 | |
| 78 | Novartis Investigative Site | Kiel | Germany | 24105 | |
| 79 | Novartis Investigative Site | Koeln | Germany | 50937 | |
| 80 | Novartis Investigative Site | Lubeck | Germany | 23538 | |
| 81 | Novartis Investigative Site | Ludwigshafen am Rhein | Germany | 67063 | |
| 82 | Novartis Investigative Site | Mainz | Germany | 55131 | |
| 83 | Novartis Investigative Site | Muenster | Germany | 48149 | |
| 84 | Novartis Investigative Site | Osnabrueck | Germany | 49074 | |
| 85 | Novartis Investigative Site | Pommelsbrunn | Germany | 91224 | |
| 86 | Novartis Investigative Site | Quedlinburg | Germany | 06484 | |
| 87 | Novartis Investigative Site | Recklinghausen | Germany | 45657 | |
| 88 | Novartis Investigative Site | Schwerin | Germany | 19055 | |
| 89 | Novartis Investigative Site | Simmern | Germany | 55469 | |
| 90 | Novartis Investigative Site | Vechta | Germany | 49377 | |
| 91 | Novartis Investigative Site | Wiesbaden | Germany | 65203 | |
| 92 | Novartis Investigative Site | Athens | GR | Greece | 115 25 |
| 93 | Novartis Investigative Site | Heraklion Crete | Greece | 711 10 | |
| 94 | Novartis Investigative Site | Patras | Greece | 265 00 | |
| 95 | Novartis Investigative Site | Afula | Israel | 1834111 | |
| 96 | Novartis Investigative Site | Be'er Sheva | Israel | 84101 | |
| 97 | Novartis Investigative Site | Jerusalem | Israel | 91120 | |
| 98 | Novartis Investigative Site | Kfar Saba | Israel | 4428164 | |
| 99 | Novartis Investigative Site | Petach Tikva | Israel | 4941492 | |
| 100 | Novartis Investigative Site | Arezzo | AR | Italy | 52100 |
| 101 | Novartis Investigative Site | Bergamo | BG | Italy | 24127 |
| 102 | Novartis Investigative Site | San Donato Milanese | MI | Italy | 20097 |
| 103 | Novartis Investigative Site | Modena | MO | Italy | 41124 |
| 104 | Novartis Investigative Site | Perugia | PG | Italy | 06100 |
| 105 | Novartis Investigative Site | Siena | SI | Italy | 53100 |
| 106 | Novartis Investigative Site | Varese | VA | Italy | 21100 |
| 107 | Novartis Investigative Site | Daugavpils | LVA | Latvia | LV-5404 |
| 108 | Novartis Investigative Site | Jelgava | LVA | Latvia | LV-3001 |
| 109 | Novartis Investigative Site | Riga | LVA | Latvia | LV-1003 |
| 110 | Novartis Investigative Site | Ventspils | LVA | Latvia | LV-3601 |
| 111 | Novartis Investigative Site | Riga | Latvia | 1012 | |
| 112 | Novartis Investigative Site | Riga | Latvia | LV-1001 | |
| 113 | Novartis Investigative Site | Kaunas | LTU | Lithuania | LT 50161 |
| 114 | Novartis Investigative Site | Klaipeda | LTU | Lithuania | 92304 |
| 115 | Novartis Investigative Site | Kaunas | Lithuania | 47144 | |
| 116 | Novartis Investigative Site | Vilnius | Lithuania | LT-07195 | |
| 117 | Novartis Investigative Site | Vilnius | Lithuania | LT-08661 | |
| 118 | Novartis Investigative Site | Bydgoszcz | Poland | 85-094 | |
| 119 | Novartis Investigative Site | Gdansk | Poland | 80-546 | |
| 120 | Novartis Investigative Site | Kielce | Poland | 25-317 | |
| 121 | Novartis Investigative Site | Krakow | Poland | 31-530 | |
| 122 | Novartis Investigative Site | Krakow | Poland | 31-913 | |
| 123 | Novartis Investigative Site | Lodz | Poland | 90-436 | |
| 124 | Novartis Investigative Site | Lublin | Poland | 20-079 | |
| 125 | Novartis Investigative Site | Olsztyn | Poland | 10-045 | |
| 126 | Novartis Investigative Site | Ossy | Poland | 42 624 | |
| 127 | Novartis Investigative Site | Poznan | Poland | 60 529 | |
| 128 | Novartis Investigative Site | Warszawa | Poland | 02-507 | |
| 129 | Novartis Investigative Site | Warszawa | Poland | 04141 | |
| 130 | Novartis Investigative Site | Wroclaw | Poland | 50-368 | |
| 131 | Novartis Investigative Site | Lisboa | Portugal | 1300-000 | |
| 132 | Novartis Investigative Site | Lisboa | Portugal | 1400-038 | |
| 133 | Novartis Investigative Site | Lisboa | Portugal | 1649-035 | |
| 134 | Novartis Investigative Site | Lisboa | Portugal | 1998-018 | |
| 135 | Novartis Investigative Site | Porto | Portugal | 4099-001 | |
| 136 | Novartis Investigative Site | Porto | Portugal | 4200 319 | |
| 137 | Novartis Investigative Site | Vila Nova de Gaia | Portugal | 4434 502 | |
| 138 | Novartis Investigative Site | Brasov | Romania | 500283 | |
| 139 | Novartis Investigative Site | Brasov | Romania | 500366 | |
| 140 | Novartis Investigative Site | Bucuresti | Romania | 010825 | |
| 141 | Novartis Investigative Site | Craiova | Romania | 200642 | |
| 142 | Novartis Investigative Site | Iasi | Romania | 700381 | |
| 143 | Novartis Investigative Site | Malacky | Slovak Republic | Slovakia | 90101 |
| 144 | Novartis Investigative Site | Bardejov | SVK | Slovakia | 085 01 |
| 145 | Novartis Investigative Site | Banska Bystrica | Slovakia | 974 01 | |
| 146 | Novartis Investigative Site | Bratislava | Slovakia | 825 56 | |
| 147 | Novartis Investigative Site | Kosice | Slovakia | 04011 | |
| 148 | Novartis Investigative Site | Svidnik | Slovakia | 08901 | |
| 149 | Novartis Investigative Site | Zilina | Slovakia | 01207 | |
| 150 | Novartis Investigative Site | Ferrol | A Coruna | Spain | 15405 |
| 151 | Novartis Investigative Site | Vitoria | Alava | Spain | 01009 |
| 152 | Novartis Investigative Site | Elda | Alicante | Spain | 03600 |
| 153 | Novartis Investigative Site | Almeria | Andalucia | Spain | 04009 |
| 154 | Novartis Investigative Site | Malaga | Andalucia | Spain | 29010 |
| 155 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
| 156 | Novartis Investigative Site | Sabadell | Barcelona | Spain | 08208 |
| 157 | Novartis Investigative Site | Jerez | Cadiz | Spain | 11407 |
| 158 | Novartis Investigative Site | Albacete | Castilla La Mancha | Spain | 02006 |
| 159 | Novartis Investigative Site | Guadalajara | Castilla La Mancha | Spain | 19002 |
| 160 | Novartis Investigative Site | Toledo | Castilla La Mancha | Spain | 45071 |
| 161 | Novartis Investigative Site | Avila | Castilla Y Leon | Spain | 05004 |
| 162 | Novartis Investigative Site | Valladolid | Castilla Y Leon | Spain | 47011 |
| 163 | Novartis Investigative Site | Lleida | Cataluna | Spain | 25198 |
| 164 | Novartis Investigative Site | Tarragona | Catalunya | Spain | 43005 |
| 165 | Novartis Investigative Site | Terrassa | Catalunya | Spain | 08221 |
| 166 | Novartis Investigative Site | Alicante | Comunidad Valenciana | Spain | 03010 |
| 167 | Novartis Investigative Site | Alicante | Comunidad Valenciana | Spain | 03550 |
| 168 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46010 |
| 169 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46017 |
| 170 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46026 |
| 171 | Novartis Investigative Site | Zamora | Espana | Spain | 49022 |
| 172 | Novartis Investigative Site | La Coruna | Galicia | Spain | 15006 |
| 173 | Novartis Investigative Site | Lugo | Galicia | Spain | 27003 |
| 174 | Novartis Investigative Site | Orense | Galicia | Spain | 32005 |
| 175 | Novartis Investigative Site | Mostoles | Madrid, Communidad De | Spain | 28933 |
| 176 | Novartis Investigative Site | Alcala de Henares | Madrid | Spain | 28805 |
| 177 | Novartis Investigative Site | Aranjuez | Madrid | Spain | 28300 |
| 178 | Novartis Investigative Site | Fuenlabrada | Madrid | Spain | 28942 |
| 179 | Novartis Investigative Site | Getafe | Madrid | Spain | 28905 |
| 180 | Novartis Investigative Site | Leganes | Madrid | Spain | 28911 |
| 181 | Novartis Investigative Site | Torrejon de Ardoz | Madrid | Spain | 28850 |
| 182 | Novartis Investigative Site | Barakaldo | Pais Vasco | Spain | 48903 |
| 183 | Novartis Investigative Site | Bilbao | Pais Vasco | Spain | 48013 |
| 184 | Novartis Investigative Site | Vigo | Pontevedra | Spain | 36200 |
| 185 | Novartis Investigative Site | Brena Alta | Santa Cruz De Tenerife | Spain | 38712 |
| 186 | Novartis Investigative Site | Talavera de la Reina | Toledo | Spain | 45600 |
| 187 | Novartis Investigative Site | Barcelona | Spain | 08029 | |
| 188 | Novartis Investigative Site | Burgos | Spain | 09006 | |
| 189 | Novartis Investigative Site | Granada | Spain | 18016 | |
| 190 | Novartis Investigative Site | Granollers | Spain | 08402 | |
| 191 | Novartis Investigative Site | Madrid | Spain | 28006 | |
| 192 | Novartis Investigative Site | Madrid | Spain | 28034 | |
| 193 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 194 | Novartis Investigative Site | Zaragoza | Spain | 50009 | |
| 195 | Novartis Investigative Site | Penzance | Cornwall | United Kingdom | TR19 7HX |
| 196 | Novartis Investigative Site | Harlow | Essex | United Kingdom | CM20 1QX |
| 197 | Novartis Investigative Site | Rothwell | GBR | United Kingdom | NN14 6JQ |
| 198 | Novartis Investigative Site | Burbage | Leicester | United Kingdom | LE10 2SE |
| 199 | Novartis Investigative Site | Harrow | Middlesex | United Kingdom | HA1 3UJ |
| 200 | Novartis Investigative Site | Bury Saint Edmonds | Suffolk | United Kingdom | IP33 2QZ |
| 201 | Novartis Investigative Site | Bradford | West Yorkshire | United Kingdom | BD5 0NA |
| 202 | Novartis Investigative Site | Bath | United Kingdom | BA2 3HT | |
| 203 | Novartis Investigative Site | Bristol | United Kingdom | BS48 1BZ | |
| 204 | Novartis Investigative Site | Chippenham | United Kingdom | SN14 6GT | |
| 205 | Novartis Investigative Site | Devon | United Kingdom | EX8 2JF | |
| 206 | Novartis Investigative Site | Durham | United Kingdom | DH1 5TW | |
| 207 | Novartis Investigative Site | East Sussex | United Kingdom | BN2 5BE | |
| 208 | Novartis Investigative Site | Exeter | United Kingdom | EX2 5DW | |
| 209 | Novartis Investigative Site | Lancaster | United Kingdom | LA1 4RP | |
| 210 | Novartis Investigative Site | London | United Kingdom | SE1 9RT | |
| 211 | Novartis Investigative Site | Middlesex | United Kingdom | TW7 6AF | |
| 212 | Novartis Investigative Site | Newcastle Upon Tyne | United Kingdom | NE1 4LP | |
| 213 | Novartis Investigative Site | Stoke-on-Trent | United Kingdom | ST4 6QG | |
| 214 | Novartis Investigative Site | Watford | United Kingdom | WD25 7NL | |
| 215 | Novartis Investigative Site | Wellingborough | United Kingdom | NN8 4RW |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02752776
Other Study ID Numbers:
- CAIN457A3401
- 2015-003701-42
First Posted:
Apr 27, 2016
Last Update Posted:
Sep 25, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 1660 participants were treated and included in the Safety set. |
|---|---|
| Pre-assignment Detail | A total of 1858 patients were screened in this study. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 663 | 673 | 324 |
| COMPLETED | 611 | 597 | 276 |
| NOT COMPLETED | 52 | 76 | 48 |
Baseline Characteristics
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 663 | 673 | 324 | 1660 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
43.2
(14.03)
|
44.4
(13.67)
|
47.4
(12.89)
|
44.5
(13.74)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
224
33.8%
|
222
33%
|
107
33%
|
553
33.3%
|
| Male |
439
66.2%
|
451
67%
|
217
67%
|
1107
66.7%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||
| Caucasian |
626
94.4%
|
642
95.4%
|
307
94.8%
|
1575
94.9%
|
| Black |
3
0.5%
|
2
0.3%
|
0
0%
|
5
0.3%
|
| Asian |
12
1.8%
|
6
0.9%
|
2
0.6%
|
20
1.2%
|
| Other |
22
3.3%
|
23
3.4%
|
15
4.6%
|
60
3.6%
|
Outcome Measures
| Title | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 |
|---|---|
| Description | 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. |
| Time Frame | 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Number (95% Confidence Interval) [Percentage of participants] |
74.7
11.3%
|
71.3
10.6%
|
61.7
19%
|
70.8
4.3%
|
| Title | Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 |
|---|---|
| Description | 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. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Number (95% Confidence Interval) [Percentage of participants] |
75.3
11.4%
|
73.3
10.9%
|
62.0
19.1%
|
71.9
4.3%
|
| Title | Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 |
|---|---|
| Description | 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. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Wk 16: DLQI cat. score: 2-5 |
18.3
2.8%
|
19.1
2.8%
|
21.2
6.5%
|
19.2
1.2%
|
| Wk 16: DLQI cat. score: 6-10 |
5.7
0.9%
|
6.3
0.9%
|
9.3
2.9%
|
6.7
0.4%
|
| Wk 16: DLQI cat. score: 11-20 |
1.2
0.2%
|
2.9
0.4%
|
5.3
1.6%
|
2.7
0.2%
|
| Wk 16:DLQI cat. score: 21-30 |
0.0
0%
|
0.5
0.1%
|
2.5
0.8%
|
0.7
0%
|
| Wk 52: DLQI cat. score: 2-5 |
17.9
2.7%
|
14.0
2.1%
|
18.2
5.6%
|
16.4
1%
|
| Wk 52: DLQI cat. score: 6-10 |
4.7
0.7%
|
7.2
1.1%
|
9.6
3%
|
6.7
0.4%
|
| Wk 52:DLQI cat. score: 11-20 |
1.8
0.3%
|
4.0
0.6%
|
8.3
2.6%
|
4.0
0.2%
|
| Wk 52:DLQI cat. score: 21-30 |
0.3
0%
|
1.5
0.2%
|
1.9
0.6%
|
1.1
0.1%
|
| Title | Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 |
|---|---|
| Description | 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. |
| Time Frame | Week 16, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Wk 16: PASI 50 |
97.7
14.7%
|
97.5
14.5%
|
95.0
29.3%
|
97.1
5.8%
|
| Wk 16: PASI 75 |
94.4
14.2%
|
92.8
13.8%
|
85.4
26.4%
|
92.0
5.5%
|
| Wk 16: PASI 90 |
82.4
12.4%
|
78.8
11.7%
|
69.0
21.3%
|
78.3
4.7%
|
| Wk 16: PASI 100 |
47.3
7.1%
|
38.8
5.8%
|
33.4
10.3%
|
41.1
2.5%
|
| Wk 16: IGA 0/1 |
87.4
13.2%
|
84.9
12.6%
|
76.2
23.5%
|
84.2
5.1%
|
| Wk 52: PASI 50 |
97.9
14.8%
|
96.3
14.3%
|
92.9
28.7%
|
96.3
5.8%
|
| Wk 52: PASI 75 |
94.4
14.2%
|
89.7
13.3%
|
83.3
25.7%
|
90.4
5.4%
|
| Wk 52: PASI 90 |
80.8
12.2%
|
75.5
11.2%
|
63.9
19.7%
|
75.3
4.5%
|
| Wk 52: PASI 100 |
56.9
8.6%
|
45.5
6.8%
|
37.0
11.4%
|
48.4
2.9%
|
| Wk 52: IGA 0/1 |
86.4
13%
|
79.9
11.9%
|
71.3
22%
|
80.8
4.9%
|
| Title | Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 |
|---|---|
| Description | 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). |
| Time Frame | Week 16, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Week 16 |
0.217
(0.2294)
|
0.201
(0.2277)
|
0.235
(0.2602)
|
0.214
(0.2352)
|
| Week 52 |
0.221
(0.2353)
|
0.193
(0.2360)
|
0.226
(0.2596)
|
0.211
(0.2408)
|
| Title | Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 |
|---|---|
| Description | 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"). |
| Time Frame | Week 16, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Week 16 |
19.7
(24.36)
|
21.4
(25.66)
|
18.7
(26.66)
|
20.2
(25.36)
|
| Week 52 |
21.7
(24.11)
|
22.6
(25.47)
|
19.5
(25.14)
|
21.7
(24.88)
|
| Title | Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 |
|---|---|
| Description | 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. |
| Time Frame | Week 16 and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 44 | 117 | 90 | 251 |
| Week 16 |
-0.7
(0.97)
|
-0.5
(0.83)
|
-0.3
(0.85)
|
-0.5
(0.87)
|
| Week 52 |
-0.7
(0.90)
|
-0.5
(0.90)
|
-0.4
(0.85)
|
-0.5
(0.88)
|
| Title | Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 |
|---|---|
| Description | 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. |
| Time Frame | 16 and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Pain: Wk 16 |
-3.0
(2.87)
|
-3.3
(3.11)
|
-3.3
(3.30)
|
-3.2
(3.06)
|
| Pain: Wk 52 |
-3.1
(2.95)
|
-3.2
(3.22)
|
-3.3
(3.36)
|
-3.2
(3.14)
|
| Itching: Wk 16 |
-4.9
(2.96)
|
-4.9
(3.06)
|
-4.8
(3.31)
|
-4.9
(3.07)
|
| Itching: Wk 52 |
-5.0
(2.92)
|
-5.0
(3.10)
|
-4.6
(3.28)
|
-4.9
(3.07)
|
| Scaling: Wk 16 |
-5.5
(2.68)
|
-5.5
(2.71)
|
-5.2
(3.26)
|
-5.4
(2.81)
|
| Scaling: Wk 52 |
-5.4
(2.72)
|
-5.3
(2.87)
|
-4.9
(3.27)
|
-5.3
(2.90)
|
| Title | Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 |
|---|---|
| Description | 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. |
| Time Frame | 16 and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Effectiveness: Wk 16 |
81.5
(24.02)
|
80.9
(25.13)
|
75.0
(23.43)
|
80.0
(24.48)
|
| Effectiveness: Wk 52 |
85.1
(20.64)
|
82.0
(25.05)
|
74.9
(24.24)
|
81.9
(23.50)
|
| Convenience: Wk 16 |
79.2
(15.50)
|
80.8
(15.83)
|
75.9
(15.20)
|
79.2
(15.67)
|
| Convenience: Wk 52 |
82.8
(15.67)
|
83.9
(15.42)
|
78.9
(15.14)
|
82.5
(15.57)
|
| Global satisfaction: Wk 16 |
83.8
(14.71)
|
83.3
(16.68)
|
75.1
(20.07)
|
81.9
(16.99)
|
| Global satisfaction: Wk 52 |
83.9
(17.23)
|
81.9
(20.38)
|
73.5
(23.10)
|
81.1
(20.14)
|
| Title | Patient Benefit Index (PBI) at Week 16 and Week 52 |
|---|---|
| Description | 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'. |
| Time Frame | Week 16 and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined |
| Measure Participants | 662 | 673 | 324 | 1659 |
| Week 16 |
3.5
(0.61)
|
3.4
(0.69)
|
3.2
(0.85)
|
3.4
(0.70)
|
| Week 52 |
3.5
(0.70)
|
3.4
(0.80)
|
3.2
(0.96)
|
3.4
(0.80)
|
Adverse Events
| Time Frame | 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. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants | ||||
| Arm/Group Description | 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. | 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. | 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. | Participants from all 3 subpopulations: Subpopulation A B & C combined | ||||
All Cause Mortality |
||||||||
| Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
Serious Adverse Events |
||||||||
| Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 43/663 (6.5%) | 44/673 (6.5%) | 32/324 (9.9%) | 119/1660 (7.2%) | ||||
| Cardiac disorders | ||||||||
| Acute myocardial infarction | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Angina pectoris | 1/663 (0.2%) | 0/673 (0%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Atrial fibrillation | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Atrial flutter | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Cardiac failure | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Cardiomyopathy | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Coronary artery disease | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Left ventricular failure | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Myocardial infarction | 2/663 (0.3%) | 2/673 (0.3%) | 0/324 (0%) | 4/1660 (0.2%) | ||||
| Palpitations | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Ventricular fibrillation | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Ear and labyrinth disorders | ||||||||
| Vertigo | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Endocrine disorders | ||||||||
| Thyroid mass | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Eye disorders | ||||||||
| Pupils unequal | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Vitreous haemorrhage | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Abdominal pain upper | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Colitis ulcerative | 2/663 (0.3%) | 0/673 (0%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Constipation | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Crohn's disease | 1/663 (0.2%) | 3/673 (0.4%) | 0/324 (0%) | 4/1660 (0.2%) | ||||
| Food poisoning | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Functional gastrointestinal disorder | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Haemorrhoids | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Ileus paralytic | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Inguinal hernia | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Oedematous pancreatitis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| General disorders | ||||||||
| Chest pain | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Non-cardiac chest pain | 1/663 (0.2%) | 0/673 (0%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Sudden death | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Hepatic cirrhosis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Immune system disorders | ||||||||
| Anaphylactic reaction | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Infections and infestations | ||||||||
| Appendicitis | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Cellulitis | 1/663 (0.2%) | 1/673 (0.1%) | 1/324 (0.3%) | 3/1660 (0.2%) | ||||
| Clostridium difficile colitis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Dermo-hypodermitis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Diverticulitis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Erysipelas | 4/663 (0.6%) | 2/673 (0.3%) | 0/324 (0%) | 6/1660 (0.4%) | ||||
| Febrile infection | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Gastroenteritis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Herpes virus infection | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Infective exacerbation of chronic obstructive airways disease | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Necrotising fasciitis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Oral candidiasis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Otitis media chronic | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Pneumonia | 1/663 (0.2%) | 0/673 (0%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Post procedural infection | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Pulmonary sepsis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Purulent discharge | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Pyelonephritis | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Respiratory tract infection viral | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Septic shock | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Tinea pedis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Tonsillitis | 0/663 (0%) | 2/673 (0.3%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Urinary tract infection | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Alcohol poisoning | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Concussion | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Fall | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Femoral neck fracture | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Head injury | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Humerus fracture | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Lower limb fracture | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Lumbar vertebral fracture | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Pelvic fracture | 0/663 (0%) | 0/673 (0%) | 2/324 (0.6%) | 2/1660 (0.1%) | ||||
| Procedural dizziness | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Radius fracture | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Skin abrasion | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Subdural haematoma | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Tendon rupture | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Upper limb fracture | 0/663 (0%) | 2/673 (0.3%) | 1/324 (0.3%) | 3/1660 (0.2%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Diabetic ketoacidosis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Type 3 diabetes mellitus | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Bursitis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Intervertebral disc protrusion | 1/663 (0.2%) | 2/673 (0.3%) | 0/324 (0%) | 3/1660 (0.2%) | ||||
| Muscular weakness | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Musculoskeletal pain | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Osteitis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Osteoarthritis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Osteonecrosis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Rotator cuff syndrome | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Adenocarcinoma of colon | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Basal cell carcinoma | 0/663 (0%) | 1/673 (0.1%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Bladder transitional cell carcinoma | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Bronchial carcinoma | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Gastrointestinal tract adenoma | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Malignant melanoma | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Myelodysplastic syndrome | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Pituitary tumour benign | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Seborrhoeic keratosis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Squamous cell carcinoma | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Thyroid cancer | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Nervous system disorders | ||||||||
| Carotid arteriosclerosis | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Cerebral infarction | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Diabetic hyperglycaemic coma | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Diabetic neuropathy | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Dizziness | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Dysaesthesia | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Facial paralysis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Generalised tonic-clonic seizure | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Headache | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Intracranial aneurysm | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Ischaemic stroke | 0/663 (0%) | 0/673 (0%) | 3/324 (0.9%) | 3/1660 (0.2%) | ||||
| Migraine | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Radiculopathy | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Transient ischaemic attack | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Abortion spontaneous | 0/663 (0%) | 1/673 (0.1%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Psychiatric disorders | ||||||||
| Alcohol abuse | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Alcohol withdrawal syndrome | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Suicidal ideation | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Suicide attempt | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Hydronephrosis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Nephrolithiasis | 0/663 (0%) | 1/673 (0.1%) | 2/324 (0.6%) | 3/1660 (0.2%) | ||||
| Renal failure | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Urinary retention | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Reproductive system and breast disorders | ||||||||
| Cervical dysplasia | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Erectile dysfunction | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Prostatitis | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Chronic obstructive pulmonary disease | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Dyspnoea | 1/663 (0.2%) | 1/673 (0.1%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Pharyngeal cyst | 1/663 (0.2%) | 0/673 (0%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Vocal cord leukoplakia | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Angioedema | 0/663 (0%) | 1/673 (0.1%) | 1/324 (0.3%) | 2/1660 (0.1%) | ||||
| Drug eruption | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Erythema multiforme | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Pruritus | 0/663 (0%) | 1/673 (0.1%) | 0/324 (0%) | 1/1660 (0.1%) | ||||
| Psoriasis | 1/663 (0.2%) | 2/673 (0.3%) | 2/324 (0.6%) | 5/1660 (0.3%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 2/663 (0.3%) | 0/673 (0%) | 0/324 (0%) | 2/1660 (0.1%) | ||||
| Hypovolaemic shock | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
| Varicose vein | 0/663 (0%) | 0/673 (0%) | 1/324 (0.3%) | 1/1660 (0.1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Subpopulation A (Naive) | Subpopulation B (Non-biologic) | Subpopulation C (Biologic) | All Participants | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 450/663 (67.9%) | 474/673 (70.4%) | 203/324 (62.7%) | 1127/1660 (67.9%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 35/663 (5.3%) | 30/673 (4.5%) | 14/324 (4.3%) | 79/1660 (4.8%) | ||||
| Toothache | 14/663 (2.1%) | 15/673 (2.2%) | 5/324 (1.5%) | 34/1660 (2%) | ||||
| General disorders | ||||||||
| Asthenia | 16/663 (2.4%) | 10/673 (1.5%) | 7/324 (2.2%) | 33/1660 (2%) | ||||
| Fatigue | 17/663 (2.6%) | 25/673 (3.7%) | 6/324 (1.9%) | 48/1660 (2.9%) | ||||
| Influenza like illness | 8/663 (1.2%) | 15/673 (2.2%) | 4/324 (1.2%) | 27/1660 (1.6%) | ||||
| Pyrexia | 11/663 (1.7%) | 12/673 (1.8%) | 8/324 (2.5%) | 31/1660 (1.9%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 24/663 (3.6%) | 27/673 (4%) | 10/324 (3.1%) | 61/1660 (3.7%) | ||||
| Conjunctivitis | 33/663 (5%) | 21/673 (3.1%) | 15/324 (4.6%) | 69/1660 (4.2%) | ||||
| Folliculitis | 16/663 (2.4%) | 21/673 (3.1%) | 7/324 (2.2%) | 44/1660 (2.7%) | ||||
| Gastroenteritis | 21/663 (3.2%) | 14/673 (2.1%) | 6/324 (1.9%) | 41/1660 (2.5%) | ||||
| Influenza | 15/663 (2.3%) | 17/673 (2.5%) | 8/324 (2.5%) | 40/1660 (2.4%) | ||||
| Nasopharyngitis | 189/663 (28.5%) | 189/673 (28.1%) | 66/324 (20.4%) | 444/1660 (26.7%) | ||||
| Oral candidiasis | 16/663 (2.4%) | 30/673 (4.5%) | 14/324 (4.3%) | 60/1660 (3.6%) | ||||
| Oral herpes | 16/663 (2.4%) | 8/673 (1.2%) | 7/324 (2.2%) | 31/1660 (1.9%) | ||||
| Otitis externa | 9/663 (1.4%) | 7/673 (1%) | 7/324 (2.2%) | 23/1660 (1.4%) | ||||
| Pharyngitis | 28/663 (4.2%) | 19/673 (2.8%) | 10/324 (3.1%) | 57/1660 (3.4%) | ||||
| Rhinitis | 37/663 (5.6%) | 37/673 (5.5%) | 11/324 (3.4%) | 85/1660 (5.1%) | ||||
| Sinusitis | 11/663 (1.7%) | 16/673 (2.4%) | 11/324 (3.4%) | 38/1660 (2.3%) | ||||
| Tinea pedis | 16/663 (2.4%) | 18/673 (2.7%) | 7/324 (2.2%) | 41/1660 (2.5%) | ||||
| Tonsillitis | 22/663 (3.3%) | 34/673 (5.1%) | 11/324 (3.4%) | 67/1660 (4%) | ||||
| Upper respiratory tract infection | 39/663 (5.9%) | 25/673 (3.7%) | 20/324 (6.2%) | 84/1660 (5.1%) | ||||
| Urinary tract infection | 26/663 (3.9%) | 21/673 (3.1%) | 13/324 (4%) | 60/1660 (3.6%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 26/663 (3.9%) | 28/673 (4.2%) | 18/324 (5.6%) | 72/1660 (4.3%) | ||||
| Back pain | 31/663 (4.7%) | 46/673 (6.8%) | 15/324 (4.6%) | 92/1660 (5.5%) | ||||
| Myalgia | 10/663 (1.5%) | 7/673 (1%) | 7/324 (2.2%) | 24/1660 (1.4%) | ||||
| Pain in extremity | 15/663 (2.3%) | 17/673 (2.5%) | 7/324 (2.2%) | 39/1660 (2.3%) | ||||
| Tendonitis | 6/663 (0.9%) | 1/673 (0.1%) | 7/324 (2.2%) | 14/1660 (0.8%) | ||||
| Nervous system disorders | ||||||||
| Headache | 76/663 (11.5%) | 79/673 (11.7%) | 21/324 (6.5%) | 176/1660 (10.6%) | ||||
| Renal and urinary disorders | ||||||||
| Haematuria | 10/663 (1.5%) | 17/673 (2.5%) | 5/324 (1.5%) | 32/1660 (1.9%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 37/663 (5.6%) | 31/673 (4.6%) | 12/324 (3.7%) | 80/1660 (4.8%) | ||||
| Oropharyngeal pain | 34/663 (5.1%) | 40/673 (5.9%) | 14/324 (4.3%) | 88/1660 (5.3%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 3/663 (0.5%) | 7/673 (1%) | 8/324 (2.5%) | 18/1660 (1.1%) | ||||
| Eczema | 25/663 (3.8%) | 20/673 (3%) | 5/324 (1.5%) | 50/1660 (3%) | ||||
| Intertrigo | 12/663 (1.8%) | 15/673 (2.2%) | 3/324 (0.9%) | 30/1660 (1.8%) | ||||
| Pruritus | 31/663 (4.7%) | 41/673 (6.1%) | 13/324 (4%) | 85/1660 (5.1%) | ||||
| Psoriasis | 20/663 (3%) | 36/673 (5.3%) | 22/324 (6.8%) | 78/1660 (4.7%) | ||||
| Urticaria | 14/663 (2.1%) | 7/673 (1%) | 3/324 (0.9%) | 24/1660 (1.4%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 26/663 (3.9%) | 31/673 (4.6%) | 8/324 (2.5%) | 65/1660 (3.9%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
| novartis.email@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02752776
Other Study ID Numbers:
- CAIN457A3401
- 2015-003701-42
First Posted:
Apr 27, 2016
Last Update Posted:
Sep 25, 2019
Last Verified:
Aug 1, 2019