EGPA patients with residual neurological neuropathy after corticosteroid therapy
Conditions
Interventions
The use of the following drugs and therapies is prohibited throughout the period from informed consent until 4 weeks after the start of study treatment (or until the discontinuation).
-Human immunoglo
Sponsors
Amano Koichi
Kanme Shinya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Men and women aged 18 years and older at the time of informed consent. -Patients who have received an explanation of the study through the informed consent form approved by the Institutional Review Board and have signed the form prior to any study-related procedure specified in the protocol. -Patients with a diagnosis of "definite EGPA" based on the diagnostic criteria of the Ministry of Health and Welfare of Japan (1998). -Patients with residual neuropathy after the following corticosteroid therapies 1) and 2) for EGPA prior to informed consent. 1) Induction therapy with 40 mg/day or more of prednisolone (or an equivalent dosage of another corticosteroid) for at least 4 weeks, followed by a reduction of dosage and then 2) Maintenance therapy with 5 to 20 mg/day of prednisolone (or an equivalent dosage of another corticosteroid) for at least 4 weeks. -Patients with the manual muscle testing (MMT) of a score of be equal to 3 or less on at least one item AND a sum MMT score of less than 130 at provisional enrollment and at definitive enrollment.
Exclusion criteria
Exclusion criteria: -Patients whose a sum score of the MMT at the definitive enrollment improved by at least 10% of room for improvement in a sum score of the MMT at the provisional enrollment. (the score at the definitive enrollment - the score at the provisional enrollment)/(144 -the score at the provisional enrollment) not lower than 0.1). -Patients who have used any prohibited drug (defined separately) during the period between informed consent and the start of study drug administration. -Patients with muscle atrophy considered ineligible for this drug. -Patients who have received a total of 2.0 g/kg of human immunoglobulin G to treat an autoimmune or inflammatory disease within 12 months before informed consent. -Patients who have received cyclophosphamide within 4 weeks before informed consent. -Patients who have newly started mepolizumab within 24 weeks before informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (before the start of study treatment) in a sum score of the MMT to 4 weeks after the start of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from baseline (before the start of study treatment) in a sum score of the MMT sum score to 2 weeks after the start of study treatment -Changes from baseline (before the start of study treatment) in the number of muscles with an MMT score of be equal to or lower than 3 to 2 and 4 weeks after the start of study treatment -Changes from baseline (before the start of study treatment) in the Pain VAS to 2 and 4 weeks after the start of study treatment -Changes from baseline (before the start of study treatment) in the numbness grade to 2 and 4 weeks after the start of study treatment -Changes from baseline (before the start of study treatment) in the BVAS to 2 and 4 weeks after the start of study treatment -Changes from baseline (before the start of study treatment) in the Modified Barthel Index to 2 and 4 weeks after the start of study treatment | — |
Contacts
Public ContactTakahiko Koizumi
Japan Blood Products Organization
Outcome results
None listed