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
Study ID
NCT06757426
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases
  • Inflammatory Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jan 3, 2025
Start date
Jan 15, 2025
Status verified
Dec 2024
Primary completion
Jul 15, 2025
Completion
Jul 15, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy
    Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy.

Primary Outcome Measure

proportion of complete remission from the disease at week 24 [ Time Frame: week 24 ]

Central Contacts

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