Back to resultsEfficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
Primary Purpose
Scleroderma, Systemic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
High-dose intravenous immunoglobulin (Venoglobulin-IH)
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma, Systemic focused on measuring Scleroderma, Systemic
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.
Sites / Locations
- Nagasaki University
Outcomes
Primary Outcome Measures
Changes in TSS at 12 weeks
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348296
Brief Title
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
Official Title
A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Benesis Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic
Keywords
Scleroderma, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
High-dose intravenous immunoglobulin (Venoglobulin-IH)
Primary Outcome Measure Information:
Title
Changes in TSS at 12 weeks
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhiko Takehara, Professor
Organizational Affiliation
Kanazawa University
Official's Role
Study Chair
Facility Information:
Facility Name
Nagasaki University
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23910617
Citation
Takehara K, Ihn H, Sato S. A randomized, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):151-6. Epub 2013 Jul 23.
Results Reference
derived
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Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
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