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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lupus Nephritis

Thank you

Trial Information

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis


Inclusion Criteria:



- Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11
classification criteria of the American College of Rheumatology for the
classification of Systemic Lupus Erythematosus, either sequentially or coincidentally

- Urine protein creatinine ratio (UPCR) ≥ 1.0 at Screening

- Biopsy within 12 months prior to screening visit indicating active proliferative
lupus glomerulonephritis International Society of Nephrology (ISN)/ Renal Pathology
Society (RPS) 2003 classification Class III or IV [excluding Class III (C), IV-S (C)
and IV-G (C)] or World Health Organization (WHO) 1982 Classification Class III or IV
(excluding IIIc, IVd)

- Evidence of active disease within 3 months of Screening, based on at least one of the
following:

- Renal Flare

- UPCR > 3 at Screening

- Active urine sediment, defined as at least one of the following:

- ≥ 5 red blood cells (RBC) per high power field (hpf)

- ≥ 5 white blood cells (WBC) per hpf

- Presence of cellular casts

- Biopsy within 3 months prior to screening visit indicating active proliferative
lupus glomerulonephritis

- Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)

Exclusion Criteria:

- Subjects with drug-induced SLE, as opposed to idiopathic SLE

- Subjects with autoimmune disease other than SLE as their main diagnosis [eg;
Rheumatoid Arthritis (RA), Multiple Sclerosis (MS)]

- Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other concomitant medical conditions that, in the opinion of the
Investigator, might place the subject at unacceptable risk for participation in this
study

- Active Central nervous system (CNS) lupus [British Isles Lupus Assessment Group
(BILAG) A or B)] with the exception of fatigue or mild stable cognitive dysfunction
[screening Magnetic Resonating Imaging (MRI) or other imaging of the brain is not
required to rule-out CNS disease in subjects who have no clinical features suggesting
active CNS disease]

- Subjects who are diagnosed as end-stage renal disease

- Subjects with persistent non-lupus related pyuria or hematuria (eg, hemorrhagic
cystitis)

- Subjects with a degree of tubulo-interstitial changes that suggests a significant and
irreversible decrease in renal function

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose

Outcome Time Frame:

At Day 365

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

IM101-291

NCT ID:

NCT01714817

Start Date:

February 2013

Completion Date:

July 2019

Related Keywords:

  • Lupus Nephritis
  • Lupus Nephritis
  • Nephritis

Name

Location

Emory University Atlanta, Georgia  30322
Local Institution Bronx, New York  
Local Institution Corona, California  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Local Institution Wilmington, North Carolina  
Local Institution Austin, Texas  
Local Institution New Orleans, Louisiana  
Local Institution Salt Lake City, Utah  
University of Alabama at Birmingham (UAB) Birmingham, Alabama  35233
Northshore Lij Health System Lake Success, New York  11042
The Feinstein Institute For Medical Research Manhasset, New York  11030
Shanahan Rheum & Immunology Pllc Raleigh, North Carolina  27617
Paramount Medical Research & Consulting, Llc Middleburg Heights, Ohio  44130
Rheumatology Consultants Pllc Knoxville, Tennessee  37909-1907