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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-07-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion, Intravenous, single dose, Day 1

Abatacept, 30 mg/kg

Group Type ACTIVE_COMPARATOR

Abatacept

Intervention Type DRUG

Infusion, Intravenous, 30mg/kg, single dose, Day 1

Abatacept, 10 mg/kg

Open-label long-term extension phase

Group Type OTHER

Abatacept

Intervention Type DRUG

Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study

Interventions

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Placebo

Infusion, Intravenous, single dose, Day 1

Intervention Type DRUG

Abatacept

Infusion, Intravenous, 30mg/kg, single dose, Day 1

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Orencia BMS-188667 Orencia BMS-188667

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No