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OpenTrials
Completed

NCT Number: NCT03828643

Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

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.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Verona

Verona, 37126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

secukinumab

Drug

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

Primary outcomes

  1. PASI75

    Time frame: week 48

Secondary outcomes

  1. PASI90

    Time frame: week 48

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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