Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

Scleroderma, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348296
• Other study ID #: 0998-A1
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2006
• Last updated: July 28, 2010
• Start date: July 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: Benesis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Drug:
• High-dose intravenous immunoglobulin (Venoglobulin-IH)

Locations

Country	Name	City	State
Japan	Nagasaki University	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Benesis Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in TSS at 12 weeks
Secondary	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.