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Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01714817
First received: October 24, 2012
Last updated: July 12, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Condition Intervention Phase
Lupus Nephritis Biological: BMS-188667 Drug: Mycophenolate mofetil Drug: Prednisone Biological: Placebo matching with BMS-188667 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: At Day 365 ]

Secondary Outcome Measures:
  • Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis [ Time Frame: At Day 365 ]
  • Mean change in Urine Protein Creatinine ratio (UPCR) from baseline in nephrotic subjects [ Time Frame: At Day 365 ]
  • Mean change in UPCR from baseline in overall population [ Time Frame: At Day 365 ]
  • Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis [ Time Frame: At Day 729 ]
  • Proportion of subjects with complete renal response of lupus glomerulonephritis in overall population [ Time Frame: At Day 729 ]
  • Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response [ Time Frame: At Day 365 ]
  • Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response [ Time Frame: At Day 729 ]
  • Time to achieving first complete renal response during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Time to achieving first partial renal response during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Proportion of subjects meeting each of the components of PR and CR over time during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Mean change from baseline in disease activity as measured by BILAG 2004 over time during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Time to and proportion of subjects with sustained change to lower level of response, ie, CR to PR or NR, PR to NR during the double-blind period [ Time Frame: Day 15 to 729 ]
    Sustained response is defined as response present at 2 consecutive visits

  • Time to first lupus treatment failure and proportion of subjects in lupus treatment failures overall, and after achievement of CR or PR during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Time to first overall treatment failure and proportion of subjects in lupus treatment failure overall, and after achievement of CR or PR during the double-blind period [ Time Frame: Day 15 to 729 ]
  • Safety assessments based on All adverse events (AEs/SAEs) [ Time Frame: Day 15 and 729 ]
    AEs = Adverse Events, SAEs = Serious Adverse Events

  • Safety assessments based on AEs of interest (infections, malignancies, autoimmune disorders, and infusional reactions) [ Time Frame: Day 15 to 729 ]
  • Safety assessments based on AEs of interest (injection site reactions) [ Time Frame: Day 897 to 1065 ]
  • Safety assessments based on Vital signs [ Time Frame: Day 15 to 729 ]
  • Safety assessments based on Laboratory test abnormalities [ Time Frame: Day 15 to 729 ]
  • Immunogenicity assessment based on Proportion of subjects with abatacept induced antibody response over time in the double blind period [ Time Frame: Day 15 to 729 ]
  • Cmin (µg/mL): Trough level serum concentration of abatacept prior to the administration of the intravenous infusion [ Time Frame: Days 1, 15, 29, 57, 85, 113, 169, 281, 337 ]
  • Cmax (µg/mL): Maximum observed serum concentration following subjects receiving active abatacept IV [ Time Frame: Day 1 to Day 337 ]
  • AUC (TAU) (µg•h/mL): Area under the serum concentration time curve over a dosing interval [ Time Frame: Days 337 to 365 ]

Enrollment: 695
Actual Study Start Date: January 22, 2013
Estimated Study Completion Date: May 6, 2021
Primary Completion Date: November 21, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-188667 + Mycophenolate mofetil + Prednisone
BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
Biological: BMS-188667
Other Name: Abatacept
Drug: Mycophenolate mofetil
Other Name: Cellcept
Drug: Prednisone
Placebo Comparator: Placebo + Mycophenolate mofetil + Prednisone
Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
Drug: Mycophenolate mofetil
Other Name: Cellcept
Drug: Prednisone Biological: Placebo matching with BMS-188667

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Note: Subjects > 16 are eligible for enrollment at selected centers

Inclusion Criteria:

  • Potential subjects must have active lupus nephritis
  • Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
  • Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
  • Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
  • There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:

    • Worsening of lupus nephritis OR
    • UPCR ≥ 3 at Screening OR
    • Active urine sediment OR
    • Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis

Inclusion Criteria for the Long-Term Extension Period:

  • Signed Written Informed Consent
  • Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment

Exclusion Criteria:

  • Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
  • 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
  • Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
  • Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714817

  Show 128 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01714817     History of Changes
Other Study ID Numbers: IM101-291
2012-000714-11 ( EudraCT Number )
Study First Received: October 24, 2012
Last Updated: July 12, 2017

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Mycophenolic Acid
Mycophenolate mofetil
Abatacept
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2017