ClinicalTrials.Veeva

Menu

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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Lupus Nephritis

Treatments

Drug: Abatacept
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00705367
IM101-217

Details and patient eligibility

About

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)

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

13 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Abatacept, 30 mg/kg
Active Comparator group
Treatment:
Drug: Abatacept
Abatacept, 10 mg/kg
Other group
Description:
Open-label long-term extension phase
Treatment:
Drug: Abatacept

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems