Skip to content

Characterization of Anti-FGFR3 Antibodies

Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02539329
Enrollment
251
Registered
2015-09-03
Start date
2015-02-03
Completion date
2022-01-17
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Peripheral Neuropathy

Keywords

neuropathy, antibodies antiFGFR3, Biological diagnostic criteria

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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),12 monthsScore to the Overall Disability Scale Score (ODSS), the Rankin Score, the International PrognosticScore (ISS).
Description for patients with anti-FGFR3 antibodies of the immune context6 monthsLevels of Antibodies anti-FGFR3
Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies12 monthsLevels of Antibodies anti-FGFR3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026