NCT05172284

Brief Summary

Formation of a registry of IMID patients to assess the evolution of resistance to conventional and target therapies. This aim is achieved by evaluating the achievement of PASI 50 and PASI 75 scores at week 16 from the start of treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress88%
Feb 2022Dec 2026

First Submitted

Initial submission to the registry

December 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 9, 2021

Last Update Submit

January 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Registry of ImmuNe-mediated inflammatory Diseases (IMIDs)

    Formation of a registry of IMID patients to assess the evolution of resistance to conventional and target therapies.

    15 years

Secondary Outcomes (2)

  • PASI 50

    15 years

  • PASI 75

    15 years

Other Outcomes (1)

  • Special populations

    15 years

Study Arms (12)

Psoriasis

Other: Questionnaires

Psoriatic arthritis

Other: Questionnaires

Atopic dermatitis

Other: Questionnaires

Chronic urticaria

Other: Questionnaires

Suppurative hydrosadenitis

Other: Questionnaires

Systemic lupus erythematosus

Other: Questionnaires

Acne vulgaris

Other: Questionnaires

Rosacea

Other: Questionnaires

Seborrheic dermatitis

Other: Questionnaires

Contact dermatitis

Other: Questionnaires

Chronic eczema of the hands

Other: Questionnaires

Vitiligo

Other: Questionnaires

Interventions

This is a collection of data from normal clinical routine: patients will be asked to record the assessments they undergo during their course of treatment, without changing clinical practice in any way. Data inherent to the following procedures will be collected: examinations, laboratory tests, imaging tests, questionnaires and rating scales.

Also known as: blood tests, instrumental and/or imaging examinations, rating scales
Acne vulgarisAtopic dermatitisChronic eczema of the handsChronic urticariaContact dermatitisPsoriasisPsoriatic arthritisRosaceaSeborrheic dermatitisSuppurative hydrosadenitisSystemic lupus erythematosusVitiligo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this study (registry) will be included all IMID patients afferent to the UO of Dermatology of IRCCS Istituto Ortopedico Galeazzi for an estimated total of 5 years of recruitment.

You may qualify if:

  • Patients with a diagnosis of IMID.
  • Patients of any age, including minors.
  • Patients treated with approved medications for the condition in question and/or phototherapy.
  • Patients who agree to sign informed consent.

You may not qualify if:

  • Patients without a diagnosis of IMID.
  • Patients who do not consent to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

MeSH Terms

Interventions

Surveys and QuestionnairesHematologic Tests

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Giovanni Damiani, Dr.

    IRCSS Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Damiani, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 29, 2021

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion (Estimated)

December 1, 2026

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations