A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis

Benesis Corporation1 site in 1 country60 target enrollmentJuly 2006

ConditionsScleroderma, Systemic

DrugsHigh-dose intravenous immunoglobulin (Venoglobulin-IH)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Scleroderma, Systemic
Sponsor: Benesis Corporation
Enrollment: 60
Locations: 1
Primary Endpoint: Changes in TSS at 12 weeks
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Benesis Corporation

Eligibility Criteria

Inclusion Criteria

•Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
•Patients who have not less than 20 points of TSS.
•Patients with no appropriate therapeutic treatment.

Exclusion Criteria

•Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
•Patients with malignant tumors.
•Patients who have the anamnesis of shock or hypersensitivity to this drug.
•Patients who have the anamnesis of cerebral infarction or 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 had any dose increase or new dosing of steroid within 12 weeks before consent.
•Patients who were administered other investigational drug within 12 weeks before consent.

Outcomes

Primary Outcomes

Changes in TSS at 12 weeks

Secondary Outcomes

Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.