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Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
This study has been completed.
Study NCT00119678   Information provided by Bristol-Myers Squibb
First Received: June 30, 2005   Last Updated: September 30, 2009   History of Changes

June 30, 2005
September 30, 2009
September 2005
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
The primary objective of this study will be to assess the proportion of subjects with new clinical flare of SLE (BILAG "A" or "B") during the 1 year double-blind treatment period.
Complete list of historical versions of study NCT00119678 on ClinicalTrials.gov Archive Site
  • 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 ]
1. Assess proportion of subjects with a new clinical flare of SLE (BILAG A or B) within the initial 6 months of the double-blind treatment period. 2. Evaluate the proportion of subjects who during the study experienced a BILAG A or B flare
 
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
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

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.

 
Phase II
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Systemic Lupus Erythematosus
  • Drug: Abatacept
  • Drug: Placebo
  • Drug: Prednisone
  • Active Comparator: Double Blind Period
  • Placebo Comparator: Double Blind Period
  • Experimental: Open Label
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
183
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   Mexico,   Puerto Rico,   South Africa,   Taiwan,   United Kingdom
 
NCT00119678
Study Director, Bristol-Myers Squibb
IM101-042
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP