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International Guillain-Barré Syndrome Outcome Study (IGOS)

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ClinicalTrials.gov Identifier: NCT01582763
Recruitment Status : Recruiting
First Posted : April 23, 2012
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. B.C. Jacobs, Erasmus Medical Center

Tracking Information
First Submitted Date April 20, 2012
First Posted Date April 23, 2012
Last Update Posted Date July 18, 2019
Study Start Date May 2012
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Guillain Barré Syndrome (GBS) disability score [ Time Frame: 1 year ]
    7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead
  • MRC sum score [ Time Frame: 1 year ]
    the sum of MRC scores of six muscle groups, including shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsiflexors on both sides, ranging from 60 (normal) to 0 (quadriplegic). 0 = no visible contraction to 5 = normal strength, score per muscle group
Original Primary Outcome Measures
 (submitted: April 20, 2012)
GBS disability score and MRC sumscore [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Overall Neuropathy Limitations Scale (ONLS) [ Time Frame: 1 year ]
    Questions regarding affection of ability in both arms and legs, with a score from 0 = normal to 5 = disability in both arms preventing all purposeful movements and a score from 0 = walking/climbing stairs/running not affected to 7 = restricted to wheelchair or bed most of the day, unable to make any purposeful movements of the legs
  • Fatigue Severity Scale (FSS) [ Time Frame: 1 year ]
    the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.
  • EurQol EQ-5D Health Questionnaire [ Time Frame: 1 year ]
    EQ-5D® is a standardized instrument for use as a measure of health outcome with a scale from 0 = the worst health you can imagine to 100 = the best health you can imagine
  • Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: one year ]
    The R-ODS is a linearly weighted scale that specifically captures activity and social participation limitations in patients with GBS, CIDP, and MGUSP. Compared to the Overall Disability Sum Score, the R-ODS represents a wider range of item difficulties, thereby better targeting patients with different ability levels. If responsive, the R-ODS will be valuable for future clinical trials and follow-up studies in these conditions. Score from 0 = not possible to perform any activity to 48 = easy to perform any activity
Original Secondary Outcome Measures
 (submitted: April 20, 2012)
  • ONLS questionnaire [ Time Frame: 1 year ]
  • FSS questionnaire [ Time Frame: 1 year ]
  • EurQol questionnaire [ Time Frame: 1 year ]
  • R-ODS questionnaire [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, cerebrospinal fluid, samples with DNA
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.
Condition
  • Guillain-Barré Syndrome
  • Miller Fisher Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • GBS
    Guillain-Barré syndrome >1000, follow-up 1-3 years
  • NC
    Normal controls (NC)
  • IC
    Infectious controls (IC)
  • OND
    Other neurological diseases (OND)
Publications * 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-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 20, 2012)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Marieke van Woerkom 0031107043831 gbsstudies@erasmusmc.nl
Contact: Bart C Jacobs, MD, DR, PHD 0031107043999 m.vanwoerkom@erasmusmc.nl
Listed Location Countries Argentina,   Australia,   Bangladesh,   Belgium,   Canada,   China,   Denmark,   France,   Germany,   Greece,   Italy,   Japan,   Malaysia,   Netherlands,   Puerto Rico,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Brazil,   India,   Mexico
 
Administrative Information
NCT Number NCT01582763
Other Study ID Numbers MEC-2011-477
3290 ( Other Identifier: Dutch Trial Registration )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr. B.C. Jacobs, Erasmus Medical Center
Study Sponsor Erasmus Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Bart Jacobs, Dr. Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date July 2019