NCT05877040

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

Status unknown Phase 2 Last updated 26 May 2023

What this trial tests

Phase 2 trial testing Rituximab in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating in 20 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
30 March 2023

30 September 2023

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 June 2019
Primary completion	30 March 2023
Estimated completion	30 September 2023
Sites	1 location across Italy

Drugs / interventions tested

• Rituximab — full drug profile →

Conditions studied

• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — all drugs for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective open-label trial with rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy not responding to conventional immune therapies.
   Doneddu PE, Cocito D, Fazio R, Benedetti L, et al · · 2024 · cited 12× · PMID 38729746 · DOI 10.1136/jnnp-2023-332844