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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00119678

Purpose

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with 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 (arthritis). All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Abatacept Drug: Placebo Drug: Prednisone	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Prednisone Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assess the proportion of subjects with new clinical flare of SLE (Adjudicated BILAG "A" or "B") [ Time Frame: during the 1 year double blind treatment period ] [ Designated as safety issue: No ]
Assess the long term safety and tolerability of abatacept in subjects with SLE who have completed the initial 12 month double-blind treatment period on a background of tapering glucocorticosteroids [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety of chronic use of abatacept [ Time Frame: double blind treatment period ] [ Designated as safety issue: No ]
Assess the Immunogenicity of abatacept during chronic use [ Time Frame: double-blind treatment period ] [ Designated as safety issue: No ]
Assess the proportion of subjects with a new clinical flare of SLE [ Time Frame: open label treatment period ] [ Designated as safety issue: No ]
Assess the total number of BILAG A flares [ Time Frame: open label treatment period ] [ Designated as safety issue: No ]
Assess SLICC/ACR Damage Index at Year 2 compared with the baseline and Year 1 [ Time Frame: open label treatment period ] [ Designated as safety issue: No ]
Assess the total exposure to glucocorticosteroids as measured by total prednisone or prednisone equivalent are under the curve (AUC) [ 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 ]

Enrollment:	183
Study Start Date:	September 2005
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Abatacept + Prednisone: Active Comparator Double Blind Period	Drug: Abatacept Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months Drug: Prednisone Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Placebo + Prednisone: Placebo Comparator Double Blind Period	Drug: Placebo Injectable, intravenous, 0 mg, every 28 days, 12 months Drug: Prednisone Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Abatacept: Experimental Open Label	Drug: Abatacept Injectable, intravenous, 10 mg/kg, every 28 days

Eligibility

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

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 (arthritis)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119678

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Locations

United States, Arizona
University Of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, California
8737 Beverly Blvd.
Los Angeles, California, United States, 90048
Office Of Geoffrey S. Dolan, Md
Long Beach, California, United States, 90808
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, Florida
Cria Research
Ft. Lauderdale, Florida, United States, 33334
United States, Illinois
The University Of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Kentuckiana Center For Better Bone And Joint Health
Louisville, Kentucky, United States, 40202
United States, Nevada
Kelly, Timothy
Las Vegas, Nevada, United States, 89128
United States, New York
Suny Downstate Medical Center
Brooklyn, New York, United States, 11203
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oklahoma
Ok Medical Research Foundations
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Texas Research Center
Sugarland, Texas, United States, 77479
Australia, Queensland
Local Institution
Cairns, Queensland, Australia, 4870
Local Institution
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
Local Institution
Clayton, Victoria, Australia, 3168
Local Institution
Heidelberg, Victoria, Australia, 3084
Austria
Local Institution
Graz, Austria, 8036
Belgium
Local Institution
Leuven, Belgium, 3000
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Bruxelles, Belgium, 1200
Brazil
Local Institution
Sao Paulo, Brazil, 04023900
Local Institution
Sao Paulo, Brazil, 01246
Local Institution
Sao Paulo, Brazil, 04233
Brazil, Goias
Local Institution
Goiania, Goias, Brazil, 74050
Brazil, Parana
Local Institution
Curitiba, Parana, Brazil, 80060
Brazil, Rio De Janeiro
Local Institution
Rio de Janeiro - Rj, Rio De Janeiro, Brazil, 20551
Brazil, Sao Paulo
Local Institution
Campinas, Sao Paulo, Brazil, 13083
Local Institution
São Paulo, Sao Paulo, Brazil, 04027
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 1L7
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3A 1M4
France
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Bordeaux Cedex, France, 33076
Local Institution
Paris Cedex 14, France, 75679
Germany
Local Institution
Duesseldorf, Germany, 40225
Local Institution
Freiburg, Germany, 79106
Local Institution
Berlin, Germany, 13125
Italy
Local Institution
Ferrara, Italy, 44100
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 137-040
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 138-736
Korea, Republic of, Sungdong-Gu
Local Institution
Seoul, Sungdong-Gu, Korea, Republic of, 133-792
Mexico
Local Institution
Aguascalientes, Mexico, 20000
Mexico, Distrito Federal
Local Institution
Mexico City, Distrito Federal, Mexico, 06726
Mexico, Michioacan
Local Institution
Morelia, Michioacan, Mexico, 58070
Puerto Rico
Local Institution
Ponce, Puerto Rico, 00716
South Africa, Kwa Zulu Natal
Local Institution
Berea, Kwa Zulu Natal, South Africa, 4001
South Africa, Western Cape
Local Institution
Panorama, Western Cape, South Africa, 7506
Taiwan
Local Institution
Taipei, Taiwan, 11217
Local Institution
Kaohsiung, Taiwan, 833
Local Institution
Taichung, Taiwan, 407
Local Institution
Taipei, Taiwan, 105
United Kingdom, Greater London
Local Institution
London, Greater London, United Kingdom, SE1 7EX

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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

PhRMA website - CSR Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-042
Study First Received:	June 30, 2005
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00119678 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

SLE

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Abatacept
Lupus Erythematosus, Systemic
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 30, 2009