Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases
1 other identifier
observational
2,000
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 11, 2022
December 1, 2021
1 year
December 9, 2021
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
Psoriatic arthritis
Atopic dermatitis
Chronic urticaria
Suppurative hydrosadenitis
Systemic lupus erythematosus
Acne vulgaris
Rosacea
Seborrheic dermatitis
Contact dermatitis
Chronic eczema of the hands
Vitiligo
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.
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Damiani, Dr.
IRCSS Ortopedico Galeazzi
Central Study Contacts
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