RecruitingPhase 2NCT03651518

Personalized Therapies in Inflammatory Complex Disease

Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

32 participants

Start Date

Oct 20, 2020

Study Type

INTERVENTIONAL

Conditions

Autoimmune Diseases Inflammatory Disease

Summary

Inflammatory diseases may display atypical features making such patients impossible to classify. Management of these cases in daily practice cannot rely on the results of clinical trials nor on guidelines. DNA and RNA mapping have become major tools to understand and sometimes direct the treatment strategy in oncology. This study aims to test whether a precise analysis of molecular pathways in inflammatory, non classified diseases, can constitute a predictive tool of therapeutic efficiency

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Patients (men or women) aged 18 years old and over
Patients presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract, eye, nerves and brain tissues, respiratory tract, cardio-vascular disorders, genito-urinary tract including kidney, musculo-skeletal tissues. Skin involvement is mandatory in order to be able to compare involved and non-involved tissue
Signed informed consent
The disease should be considered as non-classified despite classical and adapted investigations and evaluation through expert committee meeting.
The disease alters significantly quality of life. The impairment of quality of life will be assessed based on the investigator's assessment.
The disease has been resistant to at least two prior lines of treatment \[for example : Hydroxychloroquine, Chloroquine, Colchicine, Methotrexate, Ciclosporine, Azathioprine, Mycophenolate mofetil, Disulone, Corticosteroids (prednisone, prednisolone, dexamethasone, methylprednisolone…)\].

Exclusion Criteria20

Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy
Patients refusing biopsies
Pregnancy
Women of child-bearing potential unable to receive highly efficient contraception such as combined oral contraceptives, intra-uterine disposals, hormonal implants or the use of male condoms recommended in case of unstable or irregular partner or as a replacement method for transient unacessebility to hormonal method
Breastfeeding
Patients presenting disease needing urgent therapeutic measures
Patients without health insurance or social security
Participation in another interventional trial
Patients under legal protection
Patients unable to respect the wash out delay of previously taken medications before biopsy and before treatment initiation :
Hydroxychloroquine (wash out period = 30 days)
Chloroquine (wash out period = 7 days)
Colchicine (wash out period = 7 days)
Methotrexate (wash out period = 7 days)
Ciclosporine (wash out period = 14 days)
Azathioprine (wash out period = 14 days)
Mycophenolate mofetil (wash out period = 14 days)
Disulone (wash out period = 7 days)
Corticosteroids (=prednisone, prednisolone, dexamethasone, methylprednisolone) (wash out period = 7 days for doses greater than 5mg)
Patients with contra-indications to treatments : Severe or active infections including tuberculosis