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Secukinumab targets a different interleukin and has potential to be used as alternative to existing treatments. This study will provide clinical data with respect to efficacy through Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and evaluate the impact of the treatment on quality of life and work productivity in subjects with moderate to severe plaque psoriasis in the Turkish population.
To demonstrate the efficacy of secukinumab in subjects with moderate to severe plaque psoriasis based on the percentage of PASI 90 responder patients at Week 16 as compared to baseline Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4 The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16 Work productivity (measured with WPAI-PSO) at Week 16 Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16 Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Secukinumab" "Cosentyx TM" | Experimental | "Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Secukinumab" "Cosentyx TM" | Drug | "Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of PASI 90 responder patients at Week 16 as compared to baseline | The primary endpoint has been chosen as percentage of PASI 90 responder patients. PASI 90 is accepted as clear or almost clear of psoriatic lesions which are the ultimate goal of treatment in plaque psoriasis. | 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4 | Patients, who achieved PASI 75 and PASI 90 response at week 4 will be counted by using frequencies and percentages (a subject is defined as a PASI 90 responder if the PASI score is reduced by 90% or more compared to baseline visit) | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| In case of insulin resistance determined at the baseline, the change in the resistance level as measured by HOMA-IR | Change in HOMA-IR level between baseline and week 16 will be evaluated | 16 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilgun Atakan, Prof.Dr | Hacettepe University Medical Faculty | Study Director |
| Server Serdaroglu, Prof.Dr | Istanbul University Cerrahpasa Medical Faculty | Study Director |
| Emel Bulbul Baskan, Prof.Dr | Uludag University Medical Faculty | Principal Investigator |
| Erkan Alpsoy, Prof.Dr | Akdeniz University Medical Faculty | Principal Investigator |
| Ferda Artuz, Prof.Dr | Ankara City Hospital Bilkent | Principal Investigator |
| Guliz Ikizoglu, Prof.Dr | Mersin University Medical Faculty | Principal Investigator |
| Guzin Ozarmagan, Prof.Dr | Istanbul University Istanbul Medical Faculty | Principal Investigator |
| Ilgen Ertam, Prof.Dr | Ege University Medical Faculty | Principal Investigator |
| Murat Borlu, Prof.Dr | Erciyes University Medical Faculty | Principal Investigator |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16 | Investigator's Global Assessment (IGA mod 2011) score will be explained by using descriptive statistics at week 4 and week 16. Change between week 4 and week 16 comparing to baseline | 4 and 16 week |
| Work productivity (measured with WPAI-PSO) at Week 16 | Work productivity (WPAI-PSO) at week 16 will be evaluated by using descriptive statistics at week 16. Changes at work productivity through the visits will be inspected by using Repeated Measures ANOVA test. | 16 week |
| Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16 | Changes in quality of life measured with Dermatology Life Quality Index (DLQI) through visits will be evaluated by using Repeated Measures ANOVA test. | 16 week |
| Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA) | Health Assessment Questionnaire-Disability Index (HAQ-DI) will be evaluated at all visits by using descriptive statistics. The change between visits will be evaluated by Repeated Measures ANOVA test. | 16 week |
| Muzeyyen Sanlı Gonul, Ass.Prof | Dıskapi Training and Research Hospital | Principal Investigator |
| Nilgun Senturk, Prof.Dr | Ondokuz Mayıs University Medical Faculty | Principal Investigator |
| Savas Yaylı, Ass.Prof | Karadeniz Technical University | Principal Investigator |
| Serhat Inaloz, Prof.Dr. | Gaziantep University Medical Faculty | Principal Investigator |
| Sinan Dogan, Spec.Dr | Bozyaka Training and Research Hospital | Principal Investigator |
| Tulin Ergun, Prof.Dr | Marmara university Medical Faculty | Principal Investigator |