Characterization of Anti-FGFR3 Antibodies
Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies
2 other identifiers
observational
251
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2015
CompletedFirst Submitted
Initial submission to the registry
July 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedFebruary 10, 2023
February 1, 2023
6.8 years
July 31, 2015
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Evolution of clinical and electrophysiological pattern of the neuropathy for patients with anti-FGFR3 antibodies (composite measure),
12 months
Description for patients with anti-FGFR3 antibodies of the immune context
6 months
Description for patients with anti-FGFR3 antibodies of the immune context
12 months
Patient evolution during one year for patients with anti-FGFR3 antibodies to a control group of sensory neuropathy without antibodies
12 months
Study Arms (2)
patient
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.
control
Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies
Interventions
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
Eligibility Criteria
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
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- Motor or sensory-motor neuropathies
- Genetic, toxic, paraneoplasic neuropathies
- Diabetic Neuropathy.
- Neuropathy with Anti-MAG or anti-ganglioside IgM.
- Pregnant or breastfeeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CHU Bordeaux
Bordeaux, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Chu Creteil
Créteil, 94000, France
CHU de Grenoble
Grenoble, 38000, France
CHU de Limoges
Limoges, 87000, France
Hospices Civils de Lyon
Lyon, 69000, France
AP-HM
Marseille, 13000, France
CHRU de Nantes
Nantes, 44093, France
CHU de NICE
Nice, 06000, France
Hôpital BICETRE
Paris, 75000, France
Hopital Pitie Salpetriere
Paris, 75013, France
Fondation Rothschild
Paris, 75019, France
CHU Poitiers
Poitiers, France
CH Cornouailles
Quimper, France
CH Saint Denis - Hôpital Delafontaine
Saint-Denis, France
Chu Saint-Etienne
Saint-Etienne, 42055, France
Chu Strasbourg
Strasbourg, 67000, France
Related Publications (1)
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.
PMID: 31690697DERIVED
Biospecimen
blood sample for antibodies measure
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Christophe ANTOINE, PhD
CHU SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2015
First Posted
September 3, 2015
Study Start
February 3, 2015
Primary Completion
November 15, 2021
Study Completion
January 17, 2022
Last Updated
February 10, 2023
Record last verified: 2023-02