Dermatomyositis, Polymyositis
Conditions
Keywords
polymyositis, dermatomyositis, High-dose intravenous immunoglobulin, Venoglobulin-IH, Steroid-resistant polymyositis(PM) and dermatomyositis(DM)
Brief summary
This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.
Interventions
DRUGGB-0998
8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
DRUGPlacebo of GB-0998
8 mL/kg per day is intravenously administered for five successive days
Sponsors
Japan Blood Products Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have been defined as definite based on the criteria of Bohan and Peter for polymyositis and dermatomyositis. * Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.
Exclusion criteria
* Patients with malignant tumors. * Patients with acute interstitial pneumonia, including acute exacerbation of chronic. * Patients with severe muscular atrophy for a long period. * Patients with severe infectious disease. * Patients who have the anamnesis of shock or hypersensitivity to this drug. * Patients with severe hepatic disorder or severe renal disorder. * Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases. * Patients who have been diagnosed as IgA deficiency in their past history. * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant. * Patients who were administered immunoglobulin dosage within 6 weeks before consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in manual muscle strength (MMT) scores | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) | 8 weeks |
| Adverse events and laboratory tests | 8 weeks |
Countries
Japan
Outcome results
None listed