Clinical trial NCT01582763: International Guillain-Barré Syndrome Outcome Study
Official title: International GBS Outcome Study (IGOS): a Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Guillain-Barré Syndrome
Miller Fisher Syndrome
Keywords: Guillain-Barré syndrome
Polyneuropathy
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases
Outcome
Quality of life
Disability
Prognostic Determinants
Treatment
Immunoglobulins
Prognosis
Infections
Anti-ganglioside antibodies
Genetic polymorphisms
Electrophysiology
Cerebrospinal Fluid
Serum
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Guillain-Barré syndrome (GBS) or variants of GBS, including the Miller Fisher syndrome (MFS) and overlap syndromes.

Brief summary: International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

Detailed description: GBS is a post-infectious immune-mediated polyradiculoneuropathy with a highly diverse clinical course and outcome despite partially effective forms of treatment(immunoglobulins and plasma exchange). Outcome in patients with GBS has not improved in the last two decades. At present about 10 to 20% of patients remain severely disabled and about 5% die. One explanation for this stagnation is the highly variable clinical course of GBS and the lack of knowledge about the factors that determine the clinical course in individual patients with GBS. GBS may consist of distinct pathogenic subgroups, in which disease onset and progression is influenced by different types of preceding infections, anti-neural antibodies and genetic polymorphisms. Optimal treatment of individual patients may depend on the pathogenesis and clinical severity. Patients with severe forms of GBS may possibly need more intensive treatment to recover. Patients with a milder course that fully recover after standard therapy could suffer from possibly more side effects of more aggressive forms of treatment. This could only be possible if there are prognostic models that accurately predict the clinical course in individual patients. Ideally such models should be based on clinical and biological predictors that are strongly associated with disease course and known as early as possible in the acute phase of illness, when treatment with immunomodulatory therapy is most effective. Prognostic models could help to guide selective trials in specific GBS subtypes. Because of this it will be possible to treat GBS with more effective and more individual therapy.

This study aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. This information will be used to understand the diversity in clinical presentation and response to treatment of GBS. This information will also be used to develop new prognostic models to predict the clinical course and outcome accurately in individual patients with GBS.

To address these research questions it is required to conduct a prospective study with standardized collection of clinical data and biomaterials from a large group of well-defined GBS patients during a long follow-up period. Such an extensive study in a relatively rare disease as GBS can be addressed only by intensive international collaboration.

Eligibility criteria: Inclusion Criteria:

* Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of GBS, including overlap syndromes, can be included.
* Inclusion of all males and females of all ages, independent of disease severity and treatment
* Inclusion within two weeks of onset of weakness
* Inclusion of patients transferred from another hospital if the stay in the first hospital was less than one week
* Opportunity to conduct a follow-up of at least one year
* Informed consent of patient or, in case of children, of parents or legal guardians

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Guillain Barré Syndrome (GBS) disability score
timeFrame: 1 year
measure: MRC sum score
timeFrame: 1 year
Secondary outcomes:
measure: Overall Neuropathy Limitations Scale (ONLS)
timeFrame: 1 year
measure: Fatigue Severity Scale (FSS)
timeFrame: 1 year
measure: EurQol EQ-5D Health Questionnaire
timeFrame: 1 year
measure: Rasch-built Overall Disability Scale (R-ODS)
timeFrame: one year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrows Neurological Institute
state: Arizona
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: New Haven
country: United States
facility: Yale University School of medicine
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Lahey clinic Boston
state: Massachusetts
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York City
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Med
state: New York
city: New York
country: United States
facility: Montefiore MC
state: New York
city: Columbus
country: United States
facility: Wexner Medical Center at The Ohio State University
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: The university of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Buenos Aires
country: Argentina
facility: Hospital Austral
city: Buenos Aires
country: Argentina
facility: Hospital Britanico
city: Buenos Aires
country: Argentina
facility: Hospital Cesar Milstein
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas
city: Buenos Aires
country: Argentina
facility: Hospital Fleni
city: Buenos Aires
country: Argentina
facility: Hospital Garrahan
city: Buenos Aires
country: Argentina
facility: Hospital Militar
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital Sydney
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College & Hospital
city: Dhaka
country: Bangladesh
facility: ICDDR,B
city: Brussels
country: Belgium
facility: Clinique Universitaire St. Luc
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Calgary
country: Canada
facility: University of Calgary
city: Kingston
country: Canada
facility: Queens University
city: London
country: Canada
facility: University hospital LHSC
city: Toronto
country: Canada
facility: University Health Network
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiang Hospital Central South University
state: Hunan
city: Xuzhou
country: China
facility: The affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: National Hospital Copenhagen
city: Glostrup
country: Denmark
facility: Glostrup Hospital Copenhagen
city: Odense
country: Denmark
facility: Odense University Hospital
city: Marseille
country: France
facility: Hospital de la Timone
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Hôpital St. Louis de Paris
city: Strasbourg
country: France
facility: University Strassbourg
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH
city: Cologne
country: Germany
facility: University of Cologne
city: Dresden
country: Germany
facility: Universitatsklinikum Dresden
city: Duesseldorf
country: Germany
facility: Heinrich Heine University
city: Homburg
country: Germany
facility: University Hospital of Saarland
city: Würzburg
country: Germany
facility: Universitatsklinikum Würzburg
city: Larissa
country: Greece
facility: University of Thessaly
state: Thessaly
city: Genova
country: Italy
facility: University of Genova
city: la Spezia
country: Italy
facility: Ospedale Sant'Andrea La Spezia
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Milan
country: Italy
facility: University of Milan
city: Modena
country: Italy
facility: University of Modena
city: Monza
country: Italy
facility: University of Milano-Bicocca
city: Napoli
country: Italy
facility: Universita FedericoII di Napoli
city: Padova
country: Italy
facility: University of Padova
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rome
country: Italy
facility: Sant' Andrea Hospital
city: Chiba
country: Japan
facility: Chiba University School of Medicine
city: Osaka
country: Japan
facility: Kinki University School of Medicine
city: Sapporo
country: Japan
facility: Hokkaido Medical Center
city: Tochigi
country: Japan
facility: Dokkyo Medical Univeristy
city: Tokorozawa
country: Japan
facility: National Defense Medical College
city: Tokyo
country: Japan
facility: Toho University Medical Center
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuis
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: HAGA ziekenhuis
city: Den Haag
country: Netherlands
facility: MCH Westeinde
city: Dirksland
country: Netherlands
facility: Van Weel-Bethesda Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Helmond
country: Netherlands
facility: Elkerliek hospital
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis Hoorn
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Nijmegen
country: Netherlands
facility: CWZ Nijmegen
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Schiedam
country: Netherlands
facility: SSVZ
city: Tilburg
country: Netherlands
facility: St. Elisabeth hospital
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
city: Cape Town
country: South Africa
facility: University of Cape Town
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Clinica Hospital 2 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen de Sevilla
city: Bern
country: Switzerland
facility: Universityhospital Bern, Inselspital
city: Fribourg
country: Switzerland
facility: HFR - Cantonal Hospital
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
city: Lugano
country: Switzerland
facility: Ospeale Civico Lugano
city: Sion
country: Switzerland
facility: Hopital du Valais
city: St. Gallen
country: Switzerland
facility: Kantonspital St. Gallen
city: Tai Pei
country: Taiwan
facility: National Taiwan University Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: Huntingdon
country: United Kingdom
facility: Hinching Brooke Hospital
city: Larbert
country: United Kingdom
facility: NHS Forth Valley Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: National Hospital of Neurology and Neurosurgery
city: London
country: United Kingdom
facility: St. George's Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: University of Oxford
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Bart Jacobs, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Pereon Y, Burmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutierrez-Gutierrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barre Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.
citation: Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barre Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barre syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.