Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis - Full Text View

Sponsor:	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 steroid as part of this study will control the nephritis despite a protocol-defined steroid taper; the endpoint is "confirmed complete renal response", a composite including stabilization or improvement of renal function, improvement of proteinuria, and improvement of urinary sediment. The safety of this treatment will also be studied

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Steroids (prednisone or prednisolone) Drug: Abatacept Drug: Mycophenolate mofetil (MMF)	Phase II Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Depo-medrol Medrol veriderm Methylprednisolone Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Abatacept Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Proportion of subjects achieving renal response [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Proportion of subjects/time to occurrence of confirmed complete renal response [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Durability of renal 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: at month 12 ] [ Designated as safety issue: No ]
Score on quality of life scales [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
Safety/Immunogenicity of abatacept [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	303
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A1 Double Blind Period	Drug: Steroids (prednisone or prednisolone) tablets, oral, 0.5-0.8 mg/kg, daily, 52 week double blind period Drug: Mycophenolate mofetil (MMF) tablets, oral, 2-3g, daily, 52 week double blind period
Active Comparator: A2 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
A3 Open Label Period	Drug: Abatacept intravenous solution, injectable, 10 mg/kg or 30 mg/kg, every 28 days Other Names: Orencia BMS-188667

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

Eligibility

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

Criteria

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 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 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 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
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 Central nervous system (CNS) lupus
Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [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

Show 91 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00430677 History of Changes
Other Study ID Numbers:	IM101-075
Study First Received:	February 1, 2007
Last Updated:	July 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glomerulonephritis
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Kidney Diseases
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone

Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Abatacept
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on February 12, 2012