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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe français d'étude des Maladies Inflammatoires de loeil

About this trial

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.

Eligibility criteria

Qualifiers

Patients over 18 years

Enrolled in the French national social security system

Diagnosis of an inflammatory/autoimmune disease meeting internationally accepted classification criteria;

Clinical activity of their disease with biological and/or radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.

Disqualifiers

Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);

History of severe immunosuppression, HIV or HBsAg positive.

Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).

Have received live vaccines in the 3 months preceding the start of treatment.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

80 Participants
are grouped into 1 trial group