Personalized therapies for severe inflammatory diseases
Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT03651518
This study is testing if personalized treatments can help people with severe inflammatory diseases that haven’t improved with standard medications.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | Methotrexate, prednisone, Rituximab |
| Locations | 1 site (Paris) |
| Trial ID | NCT03651518 on ClinicalTrials.gov |
What this trial studies
This phase IIb study aims to evaluate the efficacy of targeted treatments for patients with severe, non-classified inflammatory diseases that have not responded to standard therapies. By utilizing molecular analysis of specific altered inflammatory signaling pathways, an algorithm will select appropriate targeted therapies for each patient. Treatments will include approved medications such as Kineret, Humira, and Stelara, administered over a six-month period. The primary efficacy endpoint will assess improvement in systemic and cutaneous activity, as well as biological markers of inflammation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with severe, non-classified inflammatory diseases affecting at least two organ systems, including mandatory skin involvement.
Not a fit: Patients whose inflammatory diseases are classified or who have not been resistant to at least two prior lines of treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide personalized treatment options for patients with complex inflammatory diseases, improving their quality of life.
How similar studies have performed: While personalized treatment approaches have shown promise in oncology, this specific application in inflammatory diseases is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Cochin — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Selim ARACTINGI, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Selim ARACTINGI, PhD
- Email: selim.aractingi@gmail.com
- Phone: + 33 1 58 41 19 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Disease, Autoimmune Diseases, Personalized treatment, Inflammatory diseases, auto-inflammatory diseases, auto-immune diseases, Targeted treatments, skin