Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220256

Enrollment

Registered

2006-06-12

Start date

2006-06-01

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

Steroid-resistant Polymyositis and Dermatomyositis

Interventions

investigational material(s) Generic name etc : GB-0998(Polyethylene Glycol Treated Human Normal Immunoglobulin) INN of investigational material : Human Normal Immunoglobulin Therapeutic category code

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Changes in manual muscle strength (MMT) scores	—

Secondary

Measure	Time frame
efficacy Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)	—

Countries

Japan

Outcome results

None listed

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