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Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, February 2009
First Received: February 1, 2007   Last Updated: May 6, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00430677
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: steroids (prednisone or prednisolone) + MMF
Drug: abatacept
Phase II
Phase III

MedlinePlus related topics: Lupus
Drug Information available for: Prednisolone Prednisolone acetate Prednisone Depo-medrol Medrol veriderm Methylprednisolone Abatacept Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 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)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Renal response [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving renal response [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Proportion of subjects maintaining renal response [ Time Frame: for at least 3 months ] [ Designated as safety issue: No ]
  • Proportion of subjects/time to occurrence of renal improvement (partial response) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Change in renal function [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • SLE disease activity/ACR Damage Index Assessment [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Score on quality of life scales [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
  • Safety of abatacept [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 303
Study Start Date: June 2007
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1: Active Comparator Drug: steroids (prednisone or prednisolone) + MMF
tablets, oral, 0.5-0.8 mg/kg + 2-3g, daily, 52 week double blind period
A2: Active Comparator Drug: abatacept
intravenous solution, injectable, 10mg/kg or 30 mg/kg, every 28 days, 52 week double blind period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430677

Contacts
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.

  Show 104 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: IM101-075
Study First Received: February 1, 2007
Last Updated: May 6, 2009
ClinicalTrials.gov Identifier: NCT00430677     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Antineoplastic Agents, Hormonal
Methylprednisolone
Lupus Nephritis
Hormone Antagonists
Lupus
Hormones, Hormone Substitutes, and Hormone Antagonists
Methylprednisolone acetate
Prednisolone acetate
Immunosuppressive Agents
Hormones
Glucocorticoids
Abatacept
Lupus Erythematosus, Systemic
Nephritis
Prednisolone
Mycophenolate mofetil
Connective Tissue Diseases
Antirheumatic Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Abatacept
Lupus Erythematosus, Systemic
Therapeutic Uses
Prednisolone
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009