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Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

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ClinicalTrials.gov Identifier: NCT03828643
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Paolo Gisondi, Universita di Verona

Brief Summary:
This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Drug: Secukinumab

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Study Type : Observational
Estimated Enrollment : 156 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Group/Cohort Intervention/treatment
Cases
Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.
Drug: Secukinumab
Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.

Controls
Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Drug: Secukinumab
Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.




Primary Outcome Measures :
  1. PASI75 [ Time Frame: week 48 ]

Secondary Outcome Measures :
  1. PASI90 [ Time Frame: week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe chronic plaque psoriasis attended two Dermatological centers of North Italy in Veneto (Azienda Ospedaliera Universitaria of Verona and Azienda Ospedaliera of Padua) dedicated to the care of patients with psoriasis
Criteria

Inclusion Criteria:

  • Patients older than 18 years old
  • Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
  • The criteria for receiving secukinumab were according to standard clinical practice.

Exclusion Criteria:

  • Patients younger than 18 years old
  • Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
  • Pregnant women and women during breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828643


Locations
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Italy
University of Verona Recruiting
Verona, Italy, 37126
Contact: Paolo Gisondi, MD    045-8122647 ext 0039    paolo.gisondi@univr.it   
Sub-Investigator: Paolo Gisondi, MD         
Sponsors and Collaborators
Universita di Verona

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Responsible Party: Paolo Gisondi, Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT03828643     History of Changes
Other Study ID Numbers: Gisondi 3
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Paolo Gisondi, Universita di Verona:
Secukinumab
loading dose
chronic plaque psoriasis
no loading dose

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs