Characterization of Anti-FGFR3 Antibodies

Sensory Peripheral Neuropathy Clinical Trial

Official title:

Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539329
• Other study ID #: 1408060
• Secondary ID: 2014-A00636-41
• Status: Completed
• Start date: February 3, 2015
• Est. completion date: January 17, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 17, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Sensory Peripheral Neuropathy

Intervention

Other:
• Neurological assessment and Blood sample
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Chu Creteil	Creteil
France	CHU de Grenoble	Grenoble
France	CHU de Limoges	Limoges
France	Hospices Civils de Lyon	Lyon
France	AP-HM	Marseille
France	CHRU de Nantes	Nantes
France	CHU de NICE	Nice
France	Fondation Rothschild	Paris
France	Hôpital BICETRE	Paris
France	Hopital Pitie Salpetriere	Paris
France	CHU Poitiers	Poitiers
France	CH Cornouailles	Quimper
France	CH Saint Denis - Hôpital Delafontaine	Saint-Denis
France	Chu Saint-Etienne	Saint-etienne
France	Chu Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),	Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).	6 months
Secondary	Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),	Score to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).	12 months
Secondary	Description for patients with anti-FGFR3 antibodies of the immune context	Levels of Antibodies anti-FGFR3	6 months
Secondary	Description for patients with anti-FGFR3 antibodies of the immune context	Levels of Antibodies anti-FGFR3	12 months
Secondary	Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies	Levels of Antibodies anti-FGFR3	12 months