Clinical trial NCT02539329: Characterization of Anti-FGFR3 Antibodies
Official title: Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensory Peripheral Neuropathy
Keywords: neuropathy
antibodies antiFGFR3
Biological diagnostic criteria
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient group : patient with clinically pure sensory peripheral neuropathy and positive for anti-FGFR3 antibodies Control group :clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
timeFrame: 12 months
measure: Description for patients with anti-FGFR3 antibodies of the immune context
timeFrame: 6 months
measure: Description for patients with anti-FGFR3 antibodies of the immune context
timeFrame: 12 months
measure: Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Creteil
country: France
facility: Chu Creteil
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: AP-HM
city: Nantes
country: France
facility: CHRU de Nantes
city: Nice
country: France
facility: CHU de NICE
city: Paris
country: France
facility: Hôpital BICETRE
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Fondation Rothschild
city: Poitiers
country: France
facility: CHU Poitiers
city: Quimper
country: France
facility: CH Cornouailles
city: Saint-Denis
country: France
facility: CH Saint Denis - Hôpital Delafontaine
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
city: Strasbourg
country: France
facility: Chu Strasbourg
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Christophe ANTOINE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassabliere F, Reynaud-Federspiel E, Franca MC Jr, Martinez ARM, Camdessanche JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.