Clinical trial NCT00705367: Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Nephritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: Inclusion Criteria:

* Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
* Stable renal disease
* No flaring of other organ systems in a minimum of the last 3 months

Exclusion Criteria:

* Unstable lupus nephritis and serum creatinine \>3 mg/dL
* Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
* Severe unstable, refractory, or progressive SLE
* History of cancer
* Participants at risk for tuberculosis
* Autoimmune disease other than SLE as main diagnosis
* Human immunodeficiency virus or herpes zoster infection
* Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants

Primary outcomes:
measure: Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs
timeFrame: From Day 1 of double-blind period to 1st dose of long-term period
measure: Short-term Period: Number of Adverse Events (AEs) Related to Study Drug
timeFrame: From Day 1 of double-blind period to 1st dose of long-term period
measure: Short-term Period: MeanSystolic and Diastolic Blood Pressure
timeFrame: Day 1 predose and postdose and Day 2
measure: Short-term Period: Mean Heart Rate
timeFrame: Day 1 predose and postdose and Day 2
measure: Short-term Period: Mean Respirations Rate
timeFrame: Day 1 predose and postdose and Day 2
measure: Short-term Period: Mean Temperature
timeFrame: Day 1 predose and postdose and Day 2
measure: Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities
timeFrame: Screening and Days 1 and 2
Secondary outcomes:
measure: Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs
timeFrame: Days 15 to 56 days post last dose of the long-term period
measure: Minimum (Cmin) Plasma Concentration of Abatacept
timeFrame: Days 15, 29, 85, 169, 253 and 337
measure: Maximum (Cmax) Plasma Concentration of Abatacept
timeFrame: Postdosing Day 1
measure: Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
timeFrame: Days 15 to 56 days post last dose of the long-term period
measure: Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
timeFrame: Days 15 to 56 days post last dose of the long-term period
measure: Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
timeFrame: Days 15 to 56 days post last dose of the long-term period
measure: Long-term Period: Number of Participants With Abatacept-specific Antibodies
timeFrame: Day15 to 56 days post last dose of the long-term period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. doi: 10.1191/096120301682430249.