Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2025-12-25 @ 4:40 AM
NCT ID:
NCT03651518
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03651518
Study Brief:
Protocol Section:
NCT03651518