Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03651518
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Selim ARACTINGI, PhD
Phone + 33 1 58 41 19 88
Email selim.aractingi@gmail.com
Status Recruiting
Phase Phase 2
Start date October 20, 2020
Completion date November 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04078698 - Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Completed NCT03266172 - A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses Phase 1
Completed NCT03649412 - A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772 Phase 1
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Completed NCT00975936 - Phase 0 Microdose Study Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Completed NCT01210716 - Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device Phase 3
Completed NCT00820469 - Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab Phase 4
Completed NCT01953523 - Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions N/A
Withdrawn NCT03239600 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS) Phase 2
Completed NCT04872257 - Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo N/A
Recruiting NCT06019611 - Epidural Stimulation in Multiple Sclerosis N/A
Recruiting NCT05030779 - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus Early Phase 1
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04005456 - Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design N/A
Recruiting NCT05085444 - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma Early Phase 1
Recruiting NCT05853835 - First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641 Phase 1