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Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

NCT00430677 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2015-03-20

Study results available
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Summary

The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

Conditions

Interventions

DRUG

Corticosteroids (prednisone or prednisolone)

tablets, oral, 0.5-0.8 mg/kg, daily

DRUG

Abatacept

intravenous solution, injectable, 30 mg/kg, every 28 days

DRUG

Abatacept

intravenous solution, injectable, 10 mg/kg, every 28 days

DRUG

Mycophenolate mofetil (MMF)

tablets, oral, 1.5 to 2 g, daily

DRUG

Abatacept

intravenous solution, injectable, 10 mg/kg, every 28 days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-09-30
Completion
2011-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Hong Kong
  • India
  • Mexico
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00430677 on ClinicalTrials.gov