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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 : Completed
First Posted : February 4, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Paolo Gisondi, Universita di Verona

Tracking Information
First Submitted Date January 31, 2019
First Posted Date February 4, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date March 20, 2019
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2019)
PASI75 [ Time Frame: week 48 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03828643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 1, 2019)
PASI90 [ Time Frame: week 48 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis
Official Title Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Psoriasis Vulgaris
Intervention
  • Drug: Secukinumab
    Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
  • Drug: Secukinumab
    Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.
Study Groups/Cohorts
  • Cases
    Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.
    Intervention: Drug: Secukinumab
  • 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.
    Intervention: Drug: Secukinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2019)
156
Original Estimated Enrollment Same as current
Actual Study Completion Date April 12, 2019
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03828643
Other Study ID Numbers Gisondi 3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Paolo Gisondi, Universita di Verona
Study Sponsor Universita di Verona
Collaborators Not Provided
Investigators Not Provided
PRS Account Universita di Verona
Verification Date April 2019