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 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

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)

Resource links provided by NLM:

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

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 - (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 ]

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

Arms	Assigned Interventions
A1: Active Comparator Double Blind Period	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 Double Blind Period	Drug: abatacept intravenous solution, injectable, 10mg/kg or 30 mg/kg, every 28 days, 52 week double blind period
A3 Open Label Period	Drug: abatacept intravenous solution, injectable, 10 mg/kg or 30 mg/kg, every 28 days

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:

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 100 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

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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-075
Study First Received:	February 1, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00430677 History of Changes
Health Authority:	United States: Food and Drug Administration

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 November 27, 2009