Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

NCT ID: NCT03828643

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.

Secukinumab

Intervention Type DRUG

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.

Secukinumab

Intervention Type DRUG

Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.

Interventions

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Secukinumab

Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.

Intervention Type DRUG

Secukinumab

Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Paolo Gisondi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Verona

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Gisondi 3

Identifier Type: -

Identifier Source: org_study_id

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