Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases

January 10, 2022 updated by: Istituto Ortopedico Galeazzi

Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases (IMIDs) REMIND Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:
          • Giovanni Damiani, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriatic arthritis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Psoriasis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Atopic dermatitis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Chronic urticaria
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Suppurative hydrosadenitis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Systemic lupus erythematosus
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Acne vulgaris
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Rosacea
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Seborrheic dermatitis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Contact dermatitis
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Chronic eczema of the hands
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales
Vitiligo
Other: Questionnaires
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.
Other Names:
  • blood tests
  • instrumental and/or imaging examinations
  • rating scales

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry of ImmuNe-mediated inflammatory Diseases (IMIDs)
Time Frame: 15 years
Formation of a registry of IMID patients to assess the evolution of resistance to conventional and target therapies.
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI 50
Time Frame: 15 years
Assess attainment of PASI 50 score from the start of treatment to all follow-ups
15 years
PASI 75
Time Frame: 15 years
Assess attainment of PASI 75 score from the start of treatment to all follow-ups
15 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Special populations
Time Frame: 15 years
Quantification and monitoring of IMID patients belonging to "special populations". Special populations include: homeless, transgender, amputees, para and quadriplegics.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Giovanni Damiani, Dr., IRCSS Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (ACTUAL)

December 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • REMIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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