Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
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ClinicalTrials.gov Identifier: NCT00119678 |
Recruitment Status :
Completed
First Posted : July 14, 2005
Results First Posted : May 9, 2011
Last Update Posted : September 22, 2014
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Systemic Lupus Erythematosus |
Interventions |
Drug: Abatacept Drug: Placebo Drug: Prednisone |
Enrollment | 183 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 263 participants were enrolled in this study and 80 were excluded from the trial due to screening failure. Of the 183 randomized, 3 were not treated and 5 were treated but excluded due to site closure. |
Arm/Group Title | Abatacept | Placebo |
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Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. | Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. |
Period Title: Double-blind Treatment Period | ||
Started | 122 | 61 |
RANDOMIZED AND TREATED | 121 | 59 |
RANDOMIZED,TREATED, AND ANALYZED | 118 | 57 |
Completed | 81 | 35 |
Not Completed | 41 | 26 |
Reason Not Completed | ||
Death | 1 | 0 |
Adverse Event | 7 | 1 |
Lack of Efficacy | 21 | 12 |
Lost to Follow-up | 1 | 2 |
Participant withdrew consent | 4 | 4 |
Participants not meeting study criteria | 0 | 1 |
Poor/Non-compliance | 3 | 0 |
Pregnancy | 0 | 2 |
Not treated | 1 | 2 |
Site closed due to non-compliance | 3 | 2 |
Period Title: Open-label Treatment Period | ||
Started | 110 [1] | 0 |
Completed | 0 | 0 |
Not Completed | 110 | 0 |
Reason Not Completed | ||
Death | 1 | 0 |
Adverse Event | 3 | 0 |
Lack of Efficacy | 9 | 0 |
Lost to Follow-up | 3 | 0 |
Participant withdrew consent | 4 | 0 |
Participants not meeting study criteria | 2 | 0 |
Pregnancy | 1 | 0 |
Administrative reasons by sponsor | 87 | 0 |
[1]
Number of participants treated
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Baseline Characteristics
Arm/Group Title | Abatacept | Placebo | Total | |
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Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. | Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. | Total of all reporting groups | |
Overall Number of Baseline Participants | 118 | 57 | 175 | |
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[Not Specified]
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Age, Continuous
[1] Median (Full Range) Unit of measure: Years |
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Number Analyzed | 118 participants | 57 participants | 175 participants | |
38.0
(18.0 to 71.0)
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36.0
(19.0 to 65.0)
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38.0
(18.0 to 71.0)
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[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 118 participants | 57 participants | 175 participants | |
Female |
104 88.1%
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55 96.5%
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159 90.9%
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Male |
14 11.9%
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2 3.5%
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16 9.1%
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[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants | 57 participants | 175 participants |
White | 74 | 39 | 113 | |
Black/African American | 12 | 4 | 16 | |
American Indian/Alaska Native | 1 | 0 | 1 | |
Asian | 28 | 13 | 41 | |
Other races | 3 | 1 | 4 | |
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
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Weight
[1] Mean (Standard Deviation) Unit of measure: Kilograms |
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Number Analyzed | 118 participants | 57 participants | 175 participants | |
68.630 (18.717) | 69.000 (14.790) | 68.750 (17.493) | ||
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
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Systemic Lupus International Collaborative Clinics/American College of Rheumatology(SLICC/ACC) score
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 118 participants | 57 participants | 175 participants |
Overall SLICC/ACR score 0 | 82 | 38 | 120 | |
Overall SLICC/ACR score 1 | 12 | 11 | 23 | |
Overall SLICC/ACR score 2 | 15 | 5 | 20 | |
Overall SLICC/ACR score >2 | 6 | 1 | 7 | |
Overall SLICC/ACR score unavailable | 3 | 2 | 5 | |
[1]
Measure Description: SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: | BMS Study Director |
Organization: | Bristol-Myers Squibb |
EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00119678 |
Other Study ID Numbers: |
IM101-042 |
First Submitted: | June 30, 2005 |
First Posted: | July 14, 2005 |
Results First Submitted: | January 10, 2011 |
Results First Posted: | May 9, 2011 |
Last Update Posted: | September 22, 2014 |