NCT00348296CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
Benesis Corporation2 sites in 1 country60 target enrollmentStarted: July 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Changes in TSS at 12 weeks
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (2)
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