Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Psoriasis Vulgaris Clinical Trial

Official title:

Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828643
• Other study ID #: Gisondi 3
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: April 12, 2019

Study information

• Verified date: April 2019
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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

Locations

Country	Name	City	State
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI75		week 48
Secondary	PASI90		week 48