Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 3, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 30, 2010
July 1, 2010
3 years
July 3, 2006
July 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in TSS at 12 weeks
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nagasaki University
Nagasaki, Nagasaki, 852-8501, Japan
Related Publications (1)
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.
PMID: 23910617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kazuhiko Takehara, Professor
Kanazawa University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 3, 2006
First Posted
July 4, 2006
Study Start
July 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 30, 2010
Record last verified: 2010-07