Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Condition(s) targeted: Systemic Lupus Erythematosus

Intervention: steroids (prednisone or prednisolone) + MMF (Drug); abatacept (Drug); abatacept (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

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

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)

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

Primary outcome:

Renal response - (Double Blind Period)

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)

Secondary outcome:

Proportion of subjects achieving renal response - (Double Blind Period)

Proportion of subjects maintaining renal response - (Double Blind Period)

Proportion of subjects/time to occurrence of renal improvement (partial response) - (Double Blind Period)

Change in renal function - (Double Blind Period)

SLE disease activity/ACR Damage Index Assessment - (Double Blind Period)

Score on quality of life scales - (Double Blind Period)

Safety of abatacept

Assess the durability of efficacy (e.g. complete renal response, renal improvement, SLICC/ACR Damage Index)

Assess glucocorticosteroid use

Assess the immunogenicity of abatacept during chronic use

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Cordoba 5016, Argentina; Recruiting
Site 074

Local Institution, Tucuman 4000, Argentina; Recruiting
Site 072

Local Institution, Leuven 3000, Belgium; Recruiting
Site 086

Local Institution, Bruxelles 1200, Belgium; Recruiting
Site 087

Local Institution, Rio De Janeiro 20551, Brazil; Active, not recruiting

Local Institution, Sao Paulo 04026, Brazil; Active, not recruiting

Local Institution, Beijing 100853, China; Recruiting
Site 126

Local Institution, Beijing 100044, China; Recruiting
Site 128

Local Institution, Beijing 100730, China; Recruiting
Site 132

Local Institution, Beijing 100034, China; Recruiting
Site 133

Local Institution, Shanghai 200001, China; Recruiting
Site 125

Local Institution, Shanghai 200025, China; Recruiting
Site 129

Local Institution, Shanghai 200001, China; Recruiting
Site 130

Local Institution, Shanghai 200025, China; Recruiting
Site 157

Local Institution, Toulouse Cedex 4 31403, France; Active, not recruiting

Local Institution, Creteil Cedex 94010, France; Active, not recruiting

Local Institution, Paris Cedex 13 75651, France; Active, not recruiting

Local Institution, Strasbourg Cedex 67098, France; Active, not recruiting

Local Institution, Hong Kong *, Hong Kong; Recruiting
Site 101

Local Institution, Hong Kong *, Hong Kong; Recruiting
Site 102

Local Institution, Hyderabad 500082, India; Recruiting
Site 042

Local Institution, Visakhapatnam 530002, India; Recruiting
Site 099

Local Institution, Seoul 137-040, Korea, Republic of; Recruiting
Site 089

Local Institution, Seoul 110-744, Korea, Republic of; Recruiting
Site 090

Local Institution, Aguascalientes 20000, Mexico; Recruiting
Site 154

Local Institution, San Luis Potosi 78240, Mexico; Not yet recruiting
Site 153

Local Institution, Wroclaw 50-417, Poland; Recruiting
Site 107

Local Institution, Bydgoszcz 85-094, Poland; Recruiting
Site 108

Local Institution, Gdansk 80-952, Poland; Recruiting
Site 109

Local Institution, Warszawa 00-909, Poland; Not yet recruiting
Site 110

Local Institution, Moscow 115522, Russian Federation; Recruiting
Site 135

Local Institution, Ekaterinburg 620102, Russian Federation; Recruiting
Site 138

Local Institution, Yaroslaval 150062, Russian Federation; Recruiting
Site 146

Local Institution, Kaohsiung 833, Taiwan; Recruiting
Site 092

Local Institution, Taichung 407, Taiwan; Recruiting
Site 093

Local Institution, Taipei 11217, Taiwan; Recruiting
Site 094

Local Institution, Taoyuan 333, Taiwan; Recruiting
Site 095

Local Institution, Taichung 402, Taiwan; Recruiting
Site 096

Local Institution, Antalya 07070, Turkey; Recruiting
Site 147

Local Institution, Ankara 06100, Turkey; Not yet recruiting
Site 149

Local Institution, Gaziantep 27310, Turkey; Not yet recruiting
Site 150

Local Institution, Gujarat, Ahmedabad 380016, India; Recruiting
Site 083

University Of Alabama At Birmingham, Birmingham, Alabama 35294, United States; Recruiting
W. Winn Chatham, Site 013, Phone: 205-934-7727

Local Institution, Edmonton, Alberta T6G 2S2, Canada; Recruiting
Site 144

Local Institution, Secunderabad, Andhra Pradesh 500003, India; Recruiting
Site 045

Arizona Arthritis Center, Tucson, Arizona 85724, United States; Recruiting
Jeffrey R Lisse, Site 003, Phone: 520-626-3608

Local Institution, Vancouver, British Columbia V5Z 1L7, Canada; Not yet recruiting
Site 163

Local Institution, Capital Federal, Buenos Aires 1015, Argentina; Recruiting
Site 071

Local Institution, Ciudad Autonoma De Buenos Aire, Buenos Aires 1055, Argentina; Recruiting
Site 073

Wallace Rheumatic Study Center, Los Angeles, California 90048, United States; Recruiting
Daniel Wallace, Site 006, Phone: 310-360-9197

Ucla Division Of Rheumatology, Los Angeles, California 90095, United States; Recruiting
Jennifer Grossman, Site 038, Phone: 310-825-7992

Valerius Medical Group &Research Ctr. Of Greater Long Beach, Long Beach, California 90806, United States; Recruiting
Nathaniel Neal, Site 161, Phone: 562-989-2374

Local Institution, Cambridge, Cambridgeshire CB2 2QQ, United Kingdom; Active, not recruiting

Denver Nephrology, Pc, Denver, Colorado 80218, United States; Recruiting
Bradley A. Marder, Site 155, Phone: 303-861-4845

Local Institution, Mexico City, Distrito Federal 06726, Mexico; Recruiting
Site 076

Local Institution, Metepec, Estado De Mexico 52140, Mexico; Recruiting
Site 080

Local Institution, Johannesburg, Gauteng 2013, South Africa; Active, not recruiting

Local Institution, Atlanta, Georgia 30342, United States; Not yet recruiting
Site 164

Local Institution, Goiania, Goias 74110, Brazil; Active, not recruiting

Local Institution, London, Greater London SE1 7EX, United Kingdom; Active, not recruiting

Local Institution, Guangzhou, Guangdong 510080, China; Recruiting
Site 131

Local Institution, Nadiad, Gujarat 387001, India; Not yet recruiting
Site 082

Local Institution, Ahmedabad, Gujarat 380 007, India; Recruiting
Site 084

Local Institution, Guadalajara, Jalisco 44100, Mexico; Recruiting
Site 117

Local Institution, Guadalajara, Jalisco 44690, Mexico; Recruiting
Site 162

University Of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Kevin Latinis, Site 021, Phone: 913-588-6009

Local Institution, Bangalore, Karnataka 560 034, India; Recruiting
Site 065

Local Institution, Bangalore, Karnataka 560 017, India; Recruiting
Site 066

Local Institution, Kochi, Kerala 682026, India; Recruiting
Site 119

Local Institution, Mumbai, Maharajhsra 400064, India; Recruiting
Site 148

Local Institution, Winnipeg, Manitoba R3A 1M4, Canada; Recruiting
Site 137

Boston University School Of Medicine, Boston, Massachusetts 02118, United States; Recruiting
Robert Lafyatis, Site 152, Phone: 617-638-4312

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States; Recruiting
Barbara Segal, Site 020

Local Institution, Westmead, New South Wales 2145, Australia; Active, not recruiting

Local Institution, Liverpool, New South Wales 2170, Australia; Active, not recruiting

Suny Downstate Medical Center, Brooklyn, New York 11203, United States; Recruiting
Olga Dvorkina, Site 009, Phone: 718-270-1662

Suny Upstate Medical University, Syracuse, New York 13210, United States; Recruiting
Andras Perl, Site 018

Northshore Lij Health System, Lake Success, New York 11042, United States; Recruiting
Richard Furie, Site 070, Phone: 516-708-2550

Hospital For Special Surgery, New York, New York 10021, United States; Recruiting
Kyriakos Kirou, Site 115, Phone: 212-606-1671

The Feinstein Institute For Medical Research, Manhasset, New York 11030, United States; Recruiting
Meggan Mackay, Site 140

University Of North Carolina At Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Mary Dooley, Site 019, Phone: 919-966-4191

Local Institution, Monterrey, Nuevo Leon 64020, Mexico; Recruiting
Site 078

Ok Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States; Recruiting
Joan T Merrill, Site 001, Phone: 405-271-7805

Local Institution, Toronto, Ontario M5T 2S8, Canada; Recruiting
Site 139

Local Institution, Curitiba, Parana 80060, Brazil; Active, not recruiting

Local Institution, Montreal, Quebec H1T 2M4, Canada; Recruiting
Site 145

Local Institution, Brisbane, Queensland 4102, Australia; Active, not recruiting

Local Institution, Porto Alegre, Rio Grande Do Sul 91610, Brazil; Active, not recruiting

Local Institution, Campinas, Sao Paulo 13083, Brazil; Active, not recruiting

Local Institution, Xi'An, Shan3xi 710032, China; Recruiting
Site 134

Local Institution, Seoul, Sungdong-Gu 133-792, Korea, Republic of; Recruiting
Site 088

Rheumatology Consultants Pllc, Knoxville, Tennessee 37909, United States; Recruiting
Richard Misischia, Site 029, Phone: 865-602-7983

Rheumatic Disease Clinical Research Center, Llc, Houston, Texas 77004, United States; Recruiting
Samuel B. Pegram, Site 159, Phone: 713-341-5930

Local Institution, Clayton, Victoria 3168, Australia; Active, not recruiting

Local Institution, Parkville, Victoria 3050, Australia; Active, not recruiting

Local Institution, Heidelberg, Victoria 3084, Australia; Active, not recruiting

Virginia Mason Medical Center, Seattle, Washington 98101, United States; Recruiting
Stanford L. Peng, Site 165, Phone: 206-223-6824

Local Institution, Observatory, Western Cape 7925, South Africa; Active, not recruiting

Local Institution, Panorama, Western Cape 7500, South Africa; Active, not recruiting

Local Institution, Merida, Yucatan 97000, Mexico; Recruiting
Site 124

BMS Clinical Trials Disclosure

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

Starting date: June 2007
Ending date: October 2010
Last updated: September 14, 2009