NCT03651518

Personalized Therapies in Inflammatory Complex Disease

Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase IIb study. The main objective of this study is to evaluate the efficacy of targeted treatments in patients displaying a non-classified, severe and resistant inflammatory disease. Targeted treatments for each patient will have been selected through an algorithm based on molecular analysis of specific altered inflammatory signaling pathway. Treatments consist in targeted therapies approved in other indications (Kineret®, Humira®, Stelara®, Cosentyx®, Roactemra® and Rituximab®) that will be given once selected using molecular analysis and decision making procedure by the Scientific committee. For each patient, one targeted treatment will be administered according to the SmPC procedure for a treatment period of 6 months. Primary efficacy endpoint: Response will be assessed at month 6 with a composite endpoint defined as improvement of at least 2 of the 3 following parameters: * 50% improvement of the systemic activity assessed by the clinician following a visual analog scale (0-10 mm), * and/or 50% improvement of cutaneous activity assessed by the involved skin surface area, * and/or 50% decrease or normalisation of biological markers of inflammation (either CRP, ESR or fibrin). An independent adjudication committee blinded to the treatment received, will review primary endpoint for all patients based on clinical files and standardized photographs, to validate the response. Other secondary criteria will be assessed. Overall, this study will require a molecular analysis done on patient's tissue, the final aim being to evaluate efficiency and tolerance of targeted treatments chosen in a personalized analysis when classification is impossible.

Conditions

• Inflammatory Disease
• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	Kineret	100 mg, once/day sc 6 months
DRUG	Humira	40 mg/15 days sc 6 months
DRUG	Stelara	45 mg/12 weeks sc, 6 months
DRUG	Cosentyx	300mg sc every week for 1 month, then 300 mg/month sc for 5 months
DRUG	Roactemra	480 mg/perf/4 weeks 6 months
DRUG	Rituximab	2 sessions of 1000 mg at inclusion and 15 days after inclusion

Timeline

• Start date: 2020-10-20
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2018-08-29
• Last updated: 2025-11-20

Locations

1 site across 1 country: France