Personalized Therapies in Inflammatory Complex Disease

• Status: Recruiting
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Adalimumab; Interleukin 1 Receptor Antagonist Protein; Rituximab; Ustekinumab

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. 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 using SF36 assessment: score less than 30 The disease has been resistant to at least two prior lines of treatment

Exclusion Criteria:

• Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy

• Patients refusing biopsies

• Pregnancy

• Breastfeeding

• Patients presenting disease needing urgent therapeutic measures

• Patients without health insurance or social security

• Participation in another trial