Research StudiesInflammatory Neuropathy Consortium
Investigator-Led International Research Studies Supported by the INC Network
- Active (ongoing or in planning) at March 2022. Videos date from June 2021.
- We do not list single-country studies, or clinical research studies sponsored by the pharmaceutical industry, although many INC members are participating in these. The most up-to-date list is at https://clinicaltrials.gov/
- A summary of active clinical research trials in inflammatory neuropathy, aimed at patients, is given at Current Clinical Trials – GBS/CIDP Foundation International
International GBS Outcome Study (IGOS)
Steering committee: Bart Jacobs, MD, PhD (chair), David Cornblath, MD, Pieter van Doorn, MD, PhD, Hans-Peter Hartung, MD, Richard Hughes, MD, FRCP, Ken Gorson, MD, Susumu Kusunoki, MD, PhD, Hugh Willison, MD, PhD
Diseases Involved: Guillain-Barré syndrome (GBS), including all clinical variants and electrophysiological subtypes.
Contact Details: firstname.lastname@example.org
IGOS is an international prospective observational cohort study that aims to identify clinical and biological determinants and predictors of disease course and outcome in GBS. The current IGOS research program consists of 37 research projects in five different research domains: clinical, laboratory, prognostic, electrophysiological and treatment studies. The study is performed by the IGOS Consortium and their expertise groups.
Participating Countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Spain, South Africa, Switzerland, Taiwan, United Kingdom, United States of America. In total 160 local investigators and their medical centers are participating.
Approximate Dates of Recruiting Patients: In May 2021, the aimed number of 2000 inclusions was reached. Follow-up from previously included patients will continue until the last (3 year) follow-up visit of the last enrolled patients (May 2024). A protocol for IGOS 2.0 is in development, which will focus on new research questions.
Further Information: https://gbsstudies.erasmusmc.nl
Clinical Trials Listing: https://clinicaltrials.gov/ct2/show/NCT01582763/
IMAGiNe (IgM Anti-MAG Peripheral Neuropathy: From Proper Assessment to Trial Needs)
Tatiana Hamadeh, Ingemar Merkies, Catharina Farber, Nicolette Notermans (NL).
Prospective observational study including registry, biobanking and development of a disease specific Rasch-built patient-reported outcome measure (IgM anti-MAG paraproteinemic neuropathy: from proper assessment to trial needs).
Currently, 181 patients are included (from centers inNetherlands, USA, Spain, Italy, Serbia, Denmark) and ethical board approvals are pend-ing for other centers that have agreed to participate.
The Inflammatory Neuropathy Consortium Base (INCbase)
Steering committee: Filip Eftimov, MD, PhD (chair), Luis Querol, MD, PhD, Jeffrey Allen, MD, Bart Jacobs, MD, PhD, Ivana Basta, MD, PhD, Eduardo Nobile-Orazio, MD, PhD, Yusuf Rajabally, MD, Jean Christophe Antoine, MD, Haruki Koike, MD, PhD
Diseases Involved: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Contact Details: email@example.com
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disorder in which symptoms, treatment response, and disease course may vary from person to person. INCbase will collect a standard set of data and biomaterials from large numbers of patients with CIDP across the globe in a modular research database which has been developed with patient privacy and investigator autonomy as first priorities. Investigators that are part of the INCbase network will have the opportunity to use the database as part of unprecedented international collaborative studies for various research objectives to improve diagnostic criteria, provide robust data on treatment responses and course of disease, and develop biomarkers of disease activity. The data may also be used on a smaller scale to securely conduct single center studies. INCbase is a investigator-initiated collaboration between international researchers, the GBS/CIDP foundation and different pharmaceutical companies, with Amsterdam UMC as coordinating center. The investigators anticipate that this study will lead to an understanding of the diagnosis, prognosis, and treatment of CIDP in an unprecedented manner. Currently, the study protocol has been approved in the 7 contries and 4 more countries are in this process of seeking ethical approval. Additional information and updates on INCbase can be found at www.incbase.org.
Participating Countries: Netherlands, Serbia, Spain, Switzerland, Taiwan, United States
Further Information: www.incbase.org
OPTIC Trial: Optimal Induction Treatment in CIDP
Filip Eftimov (NL) and Mike Lunn (UK)
IVIg+placebo versus IVIg+methylprednisolone.