A study to verify the acute therapeutic effect of mepolizumab for eosinophilic polyangiitis granulomatosis (EGPA) neuropathy(A Prospective Observational Study)

JRCT ID: jRCT1061230097

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Eosinophilic granulomatosis with polyangiitis
• Date of first enrollment: 01/02/2024
• Target sample size: 20
• Study type: Observational

Outcome(s)

• Primary Outcome: Comparison of peripheral nerve recovery rate, electrical diagnosis rate of peripheral nerve recovery, peripheral blood eosinophil count, and relapse rate with previous results.
• Secondary Outcome: Comparison of test items other than primary endpoints and safety with previous results.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients =<30 day after onset of EGPA neuropathy.
2) Patients who treated with steroid-pulse therapy (3 days) during the acute phase of EGPA neuropathy and shown no complete remission in EGPA neuropathy.
3) Patients who meet the American Society of Rheumatology EGPA classification criteria or American College of Rheumatology/European League Against Rheumatism EGPA classification criteria.
4) Patients aged 20 years or older at the time of onset of EGPA neuropathy.
5) Regardless of gender.
6) Patients who gave informed consent to participate in the study by the patient or the legally acceptable
representative after receiving adequate explanation for their participation in the study.

Exclude criteria

1) Patients being treated with mepolizumab
2) Patients who received steroid-pulse therapy (3 days) in the acute phase of EGPA neuropathy and had complete EGPA neuropaty resolution.
3) Life-threatening patients
4) Patients who were judged inappropriate by principal investigator

Related Information

• Primary Sponsor: Takeshita Yukio
• Secondary Sponsor: GlaxoSmithKline K.K.