Characterization of Anti-FGFR3 Antibodies

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Sensory Peripheral Neuropathy

Treatments: Other: Neurological assessment and Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02539329

1408060

2014-A00636-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

251 participants in 2 patient groups

patient

Description:

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.

Treatment:

Other: Neurological assessment and Blood sample

control

Description:

Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies

Treatment:

Other: Neurological assessment and Blood sample