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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Galeazzi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings