Prospective multi-center study on pathophysiological features of generalized myasthenia gravis(MG)patients treated with eculizumab

Not Applicable

• Conditions: Generalized myasthenia gravis

• Registration Number: JPRN-jRCTs031190015
• Lead Sponsor: Murai Hiroyuki

Brief Summary

The results of a study of the relationship between the efficacy of anti-AChR antibody-positive gMG patients with various complement proteins, MG-related antibody titers, and inflammatory markers before and after treatment with eculizumab suggested that anti-Kv1.4 antibody and severity of disease (MGFA classification) may be candidate predictors of response, but further research is needed to accumulate the results. However, we believe that further accumulation of research is needed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-23
• Study Completion: 2022-07-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1.Not administration history of Eculizumab
2.Anti acetylcholie receptor antibody positive (the technique does not matter)
3.Age at registration 18 years old or older in both Sexes
4.Patients with systemic myasthenia gravis ( MGFA Clinical Classification Class II-V)
5.Symptom management by IVIg or the PP is insufficient ( QMG score of 12 points or more as the standard )
6.Start Eculizumab treatment
7.Received meningococcal vaccines
8.Written informed consent

Exclusion Criteria

1.Meningococcal infectious disease
2.Hypersensitivity for an ingredient of Eculizumab
3.Ocular myasthenia gravis ( MGFA Clinical Classification Class I)
4.Participate in the trial using a unapproved drug, medical equipment or the therapy
5.Judged not eligible in participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood paramete<br>1. Complement protein concentration in plasma<br>2. MG related antibody titer in serum<br>3. Inflammatory marker in serum

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoint<br>1. QMG, MG-ADL and Neuro-QOL Fatigue (change at 26 weeks from baseline)<br><br>Safety endpoint<br>1. Serious ADRs