Characterization of Anti-FGFR3 Antibodies

Completed

• Conditions: Sensory Peripheral Neuropathy
• Interventions: Other: Neurological assessment and Blood sample

• Registration Number: NCT02539329
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.

However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

Detailed Description

In and out patients evaluated for a sensory neuropathy meeting the inclusion and non-inclusion criteria will be proposed to enter the study

At inclusion the SSN diagnostic score is calculated and a blood sample is tested for anti-FGFR3 antibody.

Follow up: Patients positive for anti-FGFR3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. A blood sample is taken at 6 and 12 months.

A subgroup of patients negative for anti-FGFR3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.

Study Timeline

• Study Start: 2015-02-03
• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2021-11-15
• Study Completion: 2022-01-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• A :Patients Male or female patient aged 18 years or more

Patients with a clinically pure sensory peripheral neuropathy including :

• idiopathic or dysimmune sensory neuronopathies
• idiopathic or dysimmune distal axonal sensory neuropathy
• sensory chronic inflammatory demyelinating polyradiculoneuropathy
• idiopathic or dysimmune small fiber neuropathies
• idiopathic or dysimmune trigeminal nerve neuropathy
• positive to antibodies anti-FGFR3

B :Controls Male or female patient aged 18 years or more

Patients with a clinically pure sensory peripheral neuropathy including :

• idiopathic or dysimmune sensory neuronopathies
• idiopathic or dysimmune distal axonal sensory neuropathy
• sensory chronic inflammatory demyelinating polyradiculoneuropathy
• idiopathic or dysimmune small fiber neuropathies
• idiopathic or dysimmune trigeminal nerve neuropathy
• negative to antibodies anti-FGFR3

Exclusion Criteria

• -Motor or sensory-motor neuropathies
• Genetic, toxic, paraneoplasic neuropathies
• Diabetic Neuropathy.
• Neuropathy with Anti-MAG or anti-ganglioside IgM.
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	Neurological assessment and Blood sample	Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies
patient	Neurological assessment and Blood sample	Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and positive for anti-FGFR3 antibodies. These patients will have Neurological assessment and Blood sample.

Primary Outcome Measures

Name	Time	Method
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),	6 months	Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).

Secondary Outcome Measures

Name	Time	Method
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),	12 months	Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).
Description for patients with anti-FGFR3 antibodies of the immune context	12 months	Levels of Antibodies anti-FGFR3
Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies	12 months	Levels of Antibodies anti-FGFR3

Trial Locations

Locations (17)

Chu Strasbourg; 🇫🇷 Strasbourg, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hôpital BICETRE; 🇫🇷 Paris, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

AP-HM; 🇫🇷 Marseille, France

CHU de NICE; 🇫🇷 Nice, France

Chu Creteil; 🇫🇷 Creteil, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Limoges; 🇫🇷 Limoges, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hopital Pitie Salpetriere; 🇫🇷 Paris, France

CHRU de Nantes; 🇫🇷 Nantes, France

CHU Poitiers; 🇫🇷 Poitiers, France

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France

CH Cornouailles; 🇫🇷 Quimper, France

CH Saint Denis - Hôpital Delafontaine; 🇫🇷 Saint-Denis, France

Fondation Rothschild; 🇫🇷 Paris, France