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

Prospective multi-center study on pathophysiological features of generalized myasthenia gravis(MG)patients treated with eculizumab: Chronological changes of blood complement proteins and MG-related antibody titers in Japanese patients - PREDICT-MG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190015

Enrollment

Registered

2019-04-23

Start date

2019-08-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized myasthenia gravis Generalized myasthenia gravis

Interventions

Bleeding volume more than normal medical treatment

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Blood paramete 1. Complement protein concentration in plasma 2. MG related antibody titer in serum 3. Inflammatory marker in serum	—

Secondary

Measure	Time frame
Efficacy endpoint 1. QMG, MG-ADL and Neuro-QOL Fatigue (change at 26 weeks from baseline) Safety endpoint 1. Serious ADRs	—

Contacts

Public ContactHiroyuki Murai

International University of Health and Welfare, Narita Hosptial

murai@iuhw.ac.jp+81-476-35-5600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026