NCT04469829

Brief Summary

A prospective, controlled, open trial in psoriasis patients with metabolic syndrome, candidate to methotrexate or secukinumab was conducted between January 2019 and May 2020. The primary end point of the study was investigating any variations in waist circumference, body mass index (BMI), blood pressure, fasting glucose, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine levels between baseline and month-6 and 12 of follow-up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

July 2, 2020

Last Update Submit

July 8, 2020

Conditions

PsoriasisMetabolic Syndrome

Keywords

psoriasismethotrexatesecukinumabmetabolic syndromesafety

Outcome Measures

Primary Outcomes (10)

  • Changes in waist circumference at month 12

    Changes in waist circumference at month 12

    12 month

  • Changes in BMI at month 12

    Changes in BMI at month 12

    12 month

  • Changes in blood pressure at month 12

    Changes in blood pressure at month 12

    12 month

  • Changes in fasting glucose at month 12

    Changes in fasting glucose at month 12

    12 month

  • Changes in total cholesterol at month 12

    Changes in total cholesterol at month 12

    12 month

  • Changes in LDL cholesterol at month 12

    Changes in LDL cholesterol at month 12

    12 month

  • changes in (HDL)-cholesterol at month 12

    changes in (HDL)-cholesterol at month 12

    12 month

  • Changes in triglycerides at month 12

    Changes in triglycerides at month 12

    12 month

  • Changes in AST at month 12

    Changes in AST at month 12

    month 12

  • Changes in ALT at month 12

    Changes in ALT at month 12

    month 12

Secondary Outcomes (1)

  • PASI75 and PASI90

    6 and 12 months

Other Outcomes (1)

  • adverse reactions

    6 and 12 months

Study Arms (2)

secukinumab

EXPERIMENTAL

patients with psoriasis and metabolic syndrome candidate for treatment with secukinumab standard doses

Drug: Secukinumab

methotrexate

ACTIVE COMPARATOR

patients with psoriasis and metabolic syndrome candidate for treatment with methotrexate dosed 15 mg/week

Drug: Methotrexate

Interventions

SecukinumabDRUG

standard doses of secukinumab for psoriasis

secukinumab
MethotrexateDRUG

Methotrexate 15 mg/week

methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years
  • being affected by moderate to severe chronic plaque psoriasis and concomitant metabolic syndrome
  • being candidate to systemic treatment with methotrexate or secukinumab according to the Italian guideline for psoriasis

You may not qualify if:

  • being affected by psoriatic arthritis, pregnancy, breast feeding,
  • having initiated a systemic treatment for psoriasis in the previous 3 months and having a clinical condition that could affect the metabolic parameters other than metabolic syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Verona

Verona, 37126, Italy

Location

MeSH Terms

Conditions

PsoriasisMetabolic Syndrome

Interventions

secukinumabMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Paolo Gisondi, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Gisondi, MD

CONTACT

045 8122546paolo.gisondi@univr.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 14, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

IT(1)