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The comparison of the efficacy and safety of efgartigimod and IVIg in the treatment of Guillain-Barré Syndrome

The comparison of the efficacy and safety of efgartigimod and IVIg in the treatment of Guillain-Barré Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090893
Enrollment
Unknown
Registered
2024-10-15
Start date
2024-10-21
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Guillain-Barré syndrome

Interventions

Efgartigimod group (Initiation of efgartigimod 10mg/kg, intravenous injection, administered twice within 5 days, within 10 days of limb weakness onset):None
IVIg group (Initiation of IVIg 0.4g/kg, intravenous injection, for 5 days, within 10 days of limb weakness onset):None

Sponsors

First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: a) Provide a signed and dated informed consent form; b) Male or female, aged =18 years; c) Meet the diagnostic criteria for GBS; d) Able to run prior to the onset of GBS symptoms; e) GBS disability scale score = 3; f) Initiation of treatment with either efgartigimod (efgartigimod 10mg/kg, intravenous injection, administered twice within 5 days) or IVIg (0.4g/kg, intravenous injection, for 5 days) within 10 days of symptom onset (calculated from limb weakness).

Exclusion criteria

Exclusion criteria: a) GBS disability scale score = 2; b) Use of efgartigimod, IVIg, plasma exchange, rituximab, or immunosuppressants within 28 days prior to treatment with efgartigimod or IVIg; c) Combined use of efgartigimod and IVIg after the onset of GBS; d) Evidence supporting the diagnosis of other peripheral neuropathies; e) Presence of severe comorbidities affecting functional assessment, such as malignancies, severe cardiovascular diseases, severe chronic obstructive pulmonary disease (COPD), etc.; f) Onset of GBS symptoms more than 10 days prior.

Design outcomes

Primary

MeasureTime frame
Guillain-Barré Syndrome Disability Scale;

Secondary

MeasureTime frame
INCAT Disability Scale;I-RODS Scale;Grip strength;MRC sum scores;

Countries

China

Contacts

Public ContactWei Zhang

First Hospital of Shanxi Medical University

zhangvey@126.com+86 188 3516 6424

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026