ImmuNe-Mediated Inflammatory DiseasesNCT05172284
Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases
An observational study of ImmuNe-Mediated Inflammatory Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ImmuNe-Mediated Inflammatory Diseases
- What is being tested?
- Questionnaires
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2022to Dec 2026
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients without a diagnosis of IMID.
- Patients who do not consent to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Giovanni Damiani, Dr.
About this study
Official title: 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.
- Conditions
- ImmuNe-Mediated Inflammatory Diseases
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called blood tests, instrumental and/or imaging examinations, rating scales
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Not described Receives: Other: Questionnaires | |
| Psoriatic arthritis | Not described Receives: Other: Questionnaires | |
| Atopic dermatitis | Not described Receives: Other: Questionnaires | |
| Chronic urticaria | Not described Receives: Other: Questionnaires | |
| Suppurative hydrosadenitis | Not described Receives: Other: Questionnaires | |
| Systemic lupus erythematosus | Not described Receives: Other: Questionnaires | |
| Acne vulgaris | Not described Receives: Other: Questionnaires | |
| Rosacea | Not described Receives: Other: Questionnaires | |
| Seborrheic dermatitis | Not described Receives: Other: Questionnaires | |
| Contact dermatitis | Not described Receives: Other: Questionnaires | |
| Chronic eczema of the hands | Not described Receives: Other: Questionnaires | |
| Vitiligo | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years
Secondary outcomes (2)
PASI 50
Assess attainment of PASI 50 score from the start of treatment to all follow-ups
Measured: 15 years
PASI 75
Assess attainment of PASI 75 score from the start of treatment to all follow-ups
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmuNe-Mediated Inflammatory DiseasesStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Damiani, Dr., Principal investigator, IRCSS Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172284
- Sponsor's protocol ID
- REMIND
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases (IMIDs) REMIND Study
- ClinicalTrials.gov ID
- NCT05172284
- Acronym / sponsor ID
- REMIND
- Conditions
- ImmuNe-Mediated Inflammatory Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients without a diagnosis of IMID.
- Patients who do not consent to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: blood tests, instrumental and/or imaging examinations, rating scalesThis 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 | Acne vulgaris, Atopic dermatitis, Chronic eczema of the hands, Chronic urticaria, Contact dermatitis, Psoriasis, Psoriatic arthritis, Rosacea, Seborrheic dermatitis, Suppurative hydrosadenitis, Systemic lupus erythematosus, Vitiligo |
Primary outcome
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.
2 secondary outcomes
PASI 50
Time frame: 15 years
PASI 75
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Damiani, Dr. principal investigator
IRCSS Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ImmuNe-Mediated Inflammatory Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Damiani, Dr. (393929403679, dr.giovanni.damiani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry of ImmuNe-mediated inflammatory Diseases (IMIDs) (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.