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

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

ChemIDplus related topics:

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

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:	474
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-075
First Received:	February 1, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00430677
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prednisone

Glomerulonephritis

Autoimmune Diseases

Lupus Nephritis

Methylprednisolone

Methylprednisolone acetate

Prednisolone acetate

Abatacept

Lupus Erythematosus, Systemic

Nephritis

Prednisolone

Mycophenolate mofetil

Connective Tissue Diseases

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Antineoplastic Agents, Hormonal

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Glucocorticoids

Hormones

Immunosuppressive Agents

Pharmacologic Actions

Therapeutic Uses

Antirheumatic Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00430677