Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Condition(s) targeted: Systemic Lupus Erythematosus

Intervention: Abatacept+Prednisone (Drug); Placebo + Prednisone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

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

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, active lupus flares in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Official title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary objective of this study will be to assess the proportion of subjects with new clinical flare of SLE (BILAG "A" or "B")

Secondary outcome:

Assess proportion of subjects with a new clinical flare of SLE (BILAG A or B)

Evaluate the proportion of subjects who experienced a BILAG A or B flare.

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

Criteria:

Inclusion Criteria:

- Subjects must be diagnosed with SLE and be experiencing an active lupus flare in at

least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit.

- Stable dose of prednisone (<30mg) for at least one month.

Exclusion Criteria:

- Subjects experiencing an active lupus flare in the kidney or central nervous systems.

- Treatment with a stable dose of azathioprine, mycophenolate mofetil,

hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study.

- Subjects with active viral or bacterial infections.

- Subjects with any other autoimmune disease as a main diagnosis.

- Prior treatment with rituximab.

Local Institution, Graz 8036, Austria

Local Institution, Leuven 3000, Belgium

Local Institution, Bruxelles 1200, Belgium

Local Institution, Sao Paulo 04023900, Brazil

Local Institution, Sao Paulo 01246, Brazil

Local Institution, Sao Paulo 04233, Brazil

Local Institution, Paris Cedex 14 75679, France

Local Institution, Bordeaux Cedex 33076, France

Local Institution, Montpellier Cedex 5 34295, France

Local Institution, Duesseldorf 40225, Germany

Local Institution, Freiburg 79106, Germany

Local Institution, Berlin 13125, Germany

Local Institution, Ferrara 44100, Italy

Local Institution, Seoul 137-040, Korea, Republic of

Local Institution, Seoul 110-744, Korea, Republic of

Local Institution, Seoul 138-736, Korea, Republic of

Local Institution, Aguascalientes 20000, Mexico

Local Institution, Ponce 00716, Puerto Rico

Local Institution, Taipei 11217, Taiwan

Local Institution, Kaohsiung 833, Taiwan

Local Institution, Taichung 407, Taiwan

Local Institution, Taipei 105, Taiwan

University Of Arizona Arthritis Center, Tucson, Arizona 85724, United States

Local Institution, Vancouver, British Columbia V5Z 1L7, Canada

8737 Beverly Blvd., Los Angeles, California 90048, United States

Office Of Geoffrey S. Dolan, Md, Long Beach, California 90808, United States

Denver Arthritis Clinic, Denver, Colorado 80230, United States

Local Institution, Mexico City, Distrito Federal 06726, Mexico

Cria Research, Ft. Lauderdale, Florida 33334, United States

Local Institution, Goiania, Goias 74050, Brazil

Local Institution, London, Greater London SE1 7EX, United Kingdom

The University Of Chicago, Chicago, Illinois 60637, United States

Kentuckiana Center For Better Bone And Joint Health, Louisville, Kentucky 40202, United States

Local Institution, Berea, Kwa Zulu Natal 4001, South Africa

Local Institution, Winnipeg, Manitoba R3A 1M4, Canada

Local Institution, Morelia, Michioacan 58070, Mexico

Kelly, Timothy, Las Vegas, Nevada 89128, United States

Suny Downstate Medical Center, Brooklyn, New York 11203, United States

Columbia University Medical Center, New York, New York 10032, United States

Ok Medical Research Foundations, Oklahoma City, Oklahoma 73104, United States

Local Institution, Curitiba, Parana 80060, Brazil

Local Institution, Cairns, Queensland 4870, Australia

Local Institution, Maroochydore, Queensland 4558, Australia

Local Institution, Rio De Janeiro - Rj, Rio De Janeiro 20551, Brazil

Local Institution, Campinas, Sao Paulo 13083, Brazil

Local Institution, São Paulo, Sao Paulo 04027, Brazil

Local Institution, Seoul, Sungdong-Gu 133-792, Korea, Republic of

Texas Research Center, Sugarland, Texas 77479, United States

Local Institution, Malvern, Victoria 3144, Australia

Local Institution, Clayton, Victoria 3168, Australia

Local Institution, Heidelberg, Victoria 3084, Australia

Local Institution, Panorama, Western Cape 7506, South Africa

BMS Clinical Trials Disclosure

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

Starting date: September 2005
Ending date: November 2007
Last updated: June 4, 2008