NCT00705367

Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Placebo	Infusion, Intravenous, single dose, Day 1
DRUG	Abatacept	Infusion, Intravenous, 30mg/kg, single dose, Day 1
DRUG	Abatacept	Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-01-01
• Completion: 2011-07-01
• First posted: 2008-06-26
• Last updated: 2013-07-30
• Results posted: 2010-06-03

Locations

1 site across 1 country: China