Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis


Tracking Information

Start Date  ICMJEJune 2007
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 14, 2009)
  • Renal response - (Double Blind Period) [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]
  • Assess the long term safety and tolerability of abatacept in subjects who have completed the initial 12 month double-blind treatment period on a background of Mycophenolate Mofetil and of tapering glucocorticosteroids - (Open Label Period) [ Time Frame: Open label treatment period ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: February 1, 2007)		Time to occurrence of renal response
Change HistoryComplete list of historical versions of study NCT00430677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 14, 2009)
  • Proportion of subjects achieving renal response - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Proportion of subjects maintaining renal response - (Double Blind Period) [ Time Frame: for at least 3 months ] [ Designated as safety issue: No ]
  • Proportion of subjects/time to occurrence of renal improvement (partial response) - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Change in renal function - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • SLE disease activity/ACR Damage Index Assessment - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Score on quality of life scales - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Safety of abatacept [ Time Frame: Double Blind Period ] [ Designated as safety issue: Yes ]
  • Assess the durability of efficacy (e.g. complete renal response, renal improvement, SLICC/ACR Damage Index) [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
  • Assess glucocorticosteroid use [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
  • Assess the immunogenicity of abatacept during chronic use [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: February 1, 2007)
  • Proportion of subjects achieving renal response within 1 year
  • Proportion of subjects maintaining renal response for at least 3 months
  • Proportion of subjects/time to occurrence of renal improvement (partial response) within 1 year
  • Change in renal function within 1 year
  • SLE disease activity/ACR Damage Index Assessment
  • Score on quality of life scales
  • Safety of abatacept

Descriptive Information

Brief Title  ICMJEEfficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Official Title  ICMJEA Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)
Brief Summary

The purpose of this clinical research study is to learn if abatacept treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and steroids as part of this study will control the nephritis despite a protocol-defined steroid taper; the endpoint is a "complete renal response", a composite including normalization of renal function (or stable normal function if function was normal at study entry) plus disappearance of protein and cells/casts from the urinary sediment. The safety of this treatment will also be studied

Detailed Description

Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study

Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study

Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJESystemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: steroids (prednisone or prednisolone) + MMF
    tablets, oral, 0.5-0.8 mg/kg + 2-3g, daily, 52 week double blind period
  • Drug: abatacept
    intravenous solution, injectable, 10mg/kg or 30 mg/kg, every 28 days, 52 week double blind period
    Other Names:
    • Orencia
    • BMS-188667
  • Drug: abatacept
    intravenous solution, injectable, 10 mg/kg or 30 mg/kg, every 28 days
    Other Names:
    • Orencia
    • BMS-188667
Study Arms / Comparison Groups
  • A1: Active Comparator
    Double Blind Period
    Intervention: Drug: steroids (prednisone or prednisolone) + MMF
  • A2: Active Comparator
    Double Blind Period
    Intervention: Drug: abatacept
  • A3
    Open Label Period
    Intervention: Drug: abatacept

Recruitment Information

Estimated Enrollment  ICMJE303
Estimated Completion DateOctober 2010
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 coincident. The 4 criteria need not be present at study entry
  • Renal Biopsy within 12 months of randomization (Day 1) indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-g (C)] or WHO 1982 Classification Class III or IV (excluding Class IIIc, IVd).
  • Active renal disease at the screening visit, as defined by: urinary protein/creatinine ratio ≥0.5 AND an active urinary sediment as defined by at least one of the following 3 criteria: i) >5 RBC/hpf OR ii) >5 WBC/hpf (with no evidence of a urinary tract infection) OR iii) cylindruria AND
  • A Stable serum creatine ≤3 mg/dL

Exclusion Criteria:

  • Subjects with a rise in serum creatine of ≥1 mg/dL within 1 month prior to the screening visit
  • Subjects with drug-induced SLE, as opposed to idiopathic SLE
  • Subjects with severe, unstable and/or progressive CNS lupus
  • Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
  • Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
  • Subjects who have received treatment with rituximab < 6 months prior to the screening visit
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   France,   Hong Kong,   India,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   South Africa,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00430677
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJEIM101-075
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb