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NOT YET RECRUITING
NCT06757426

Prospective Observational Study Evaluating the Safety and Efficacy of Immunomodulatory Therapies in Refractory Inflammatory and Autoimmune Diseases

Sponsor: Groupe français d'étude des Maladies Inflammatoires de loeil

View on ClinicalTrials.gov

Summary

Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies. Prescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and/or autoimmune diseases.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2025-01-15

Completion Date

2028-07-15

Last Updated

2025-01-03

Healthy Volunteers

No

Locations (17)

Clinique Axium - Aix-en-provence

Aix-en-Provence, France

CH Simone Veil de BLOIS

Blois, France

CHU Caen Normandie

Caen, France

CH du Mans

Le Mans, France

APHM_Hôpital La Conception

Marseille, France

APHM_Hôpital Nord

Marseille, France

GHSIF Melun

Melun, France

GHI Le Raincy Montfermeil

Montfermeil, France

CHU Nantes - Hotel-Dieu

Nantes, France

CHU Rouen_Hôpital Charles Nicolle

Rouen, France

Clinique Saint-Exupéry

Saint-Exupéry, France

CHRU de Tours_Hôpital Bretenneau

Tours, France

APHP_Hopital Lariboisière

Paris, Île-de-France Region, France

APHP_Hôpital St Antoine

Paris, Île-de-France Region, France

APHP_ Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France

APHP_Hôpital Bichat

Paris, Île-de-France Region, France

APHP_Hopital Ambroise Paré

Paris, Île-de-France Region, France