A Proof of Concept Study With Rituximab in Patients With CIDP Not Responding to Conventional Immune Therapy

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Clinical Trial

Official title:
Anti-nerve Reactivity as Predictor of Response to Immune Therapy in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP): A Proof of Concept Study With Rituximab in Patients With CIDP Not Responding to Conventional Immune Therapy

Status Active, not recruiting

Clinical Trial Summary

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a chronic and often disabling neuropathy that often responds to immune therapies. A few phenotypes have been identified even if it is unclear whether they are variants of CIDP or different diseases considering their relatively different responses to therapy. Antibodies against proteins at the node of Ranvier, including contactin 1 and neurofascin 155, have been reported in up to 10% of the patients and were associated to a poor response to CIDP therapy but a positive response to Rituximab supporting the heterogeneity of CIDP. We will examine these antibodies in a large population of Italian CIDP patients included in a Database and correlate their presence with the clinical and electrophysiological features of the neuropathy, its progression and response to therapy. We will perform an open label prospective therapeutic study with Rituximab in patients with CIDP not responsive to conventional immune therapies and will correlate the response to therapy to the clinical phenotype and the presence of anti-neural antibodies.This may lead to a more appropriate choice of therapy in CIDP avoiding the use of expensive and possibly ineffective therapy. We will also collect the biological samples (serum and when available CSF) of the patients with CIDP and store them to allow the formation of a biological bank that may be used in future immunological studies to clarify the pathogenesis a of the disease and possibly to identify biomarkers of the disease and of response to therapy. This study will permit to collect a sufficiently large number of adequately and homogeneously examined patients with CIDP, with different antibody reactivities and with unsatisfactory response to therapy. This will permit to have sufficiently large number of patients to perform an open-label study with Rituximab whose efficacy has been so far reported only in anecdotal reports on small number of patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Clinical Trial Details

NCT number	NCT05877040
Study type	Interventional
Source	Istituto Clinico Humanitas
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 1, 2019
Completion date	September 30, 2023

View Details

See also
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Completed	`NCT00305266` - Study of CIDP Patients During IVIG Treatment	N/A
Completed	`NCT00004939` - Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy	Phase 3
Completed	`NCT01017159` - Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)	Phase 2
Completed	`NCT00220740` - Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Phase 3
Completed	`NCT06325943` - Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.