Personalized Therapies in Inflammatory Complex Disease

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 27, 2018

Keywords

ClinConnect Summary

The clinical trial titled "Personalized Therapies in Inflammatory Complex Disease" is looking at how a detailed analysis of DNA and RNA can help guide treatment for patients with certain inflammatory diseases that are difficult to classify. These diseases can affect multiple parts of the body, such as the skin, joints, and digestive system, and often do not respond well to standard treatments. The goal is to see if understanding the molecular pathways involved in these conditions can help doctors predict which therapies will be most effective for individual patients.

To participate in this trial, you must be at least 18 years old and have an inflammatory disease that affects at least two organs, with skin involvement being necessary for comparisons. You should also have experienced significant challenges in your quality of life due to the disease and have not responded to at least two previous treatments. If you choose to participate, you can expect to undergo some tests, including skin biopsies, and work closely with a team of medical professionals who will monitor your progress. It's important to note that there are specific criteria for eligibility, including the need for certain health conditions to be met, so not everyone will qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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