Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.

Study Overview

• Status: Recruiting
• Conditions: Guillain-barre Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zhu MD Jiitng, PhD; Phone Number: 13559947905; Email: zjtzjt11@yeah.net
• Study Contact Backup: Name: Ying Fu, PhD; Phone Number: +8613920263688; Email: fuying1995@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Neurology,First Affiliated Hospital of Fujian Medical University
      • Contact: Wang MD Ning, PhD; Phone Number: +86-0591-87982772; Email: ningwang@fjmu.edu.cn
      • Principal Investigator: Wang Ning, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with GBS after standard IVIg treatment in relation to slow clinical course or worse outcome

Description

Inclusion Criteria:

1. Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
2. Age ≥18;
3. Patients with AIDP, AMAN and AMSAN;

5. IVIG was treated within 2 weeks of onset; 6. GBS disability scale>2; 6. Cooperate with patients who were followed up for 180 days and sign the informed consent;

Exclusion criteria:

1. Age <18;
2. Pregnant or nursing women;
3. Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
4. Combined with other types of immune system diseases;
5. Accept drugs that affect the function of the immune system within 5 or 3 months;
6. Concomitant neoplastic diseases.
7. The patient or guardian refused to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GBS disability score	GBS disability scale ( Guillain-Barré syndrome disability scale) was defined as follows: 0: healthy state; 1: minor symptoms and capable of running; 2: able to walk 5 meters or more without assistance but unable to run; 3: able to walk 5 meters across an open space with help; 4: bedridden or chair-bound; 5: requiring assisted ventilation for at least part of the day; 6: dead	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function	whether mechanical ventilation is required	6 months

Collaborators and Investigators

• Sponsor: Ning Wang, MD., PhD.
• Investigators: Principal Investigator: Ning Wang, MD, First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Anticipated): January 21, 2024
• Study Completion (Anticipated): January 21, 2025

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Syndrome; Guillain-Barre Syndrome
• Other Study ID Numbers: MRCTA，ECFAH of FMU[2019]217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No