| 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
|
| |
| |
| 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
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| 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 |