Phase 2
N=183
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00119678 ↗Enrolled (actual)
183
Serious AEs
15.6%
Results posted
May 2011
Primary outcome: Primary: Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare — 94; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abatacept (Drug); Placebo (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare |
94; 47 | — |
| PRIMARY Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs |
1; 97; 21; 3; 49; 11 | — |
| PRIMARY OL; Number of Participants With Significant AEs of Special Interest |
82; 1; 4; 3; 15 | — |
| PRIMARY OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count |
2; 3; 2; 3 | — |
| PRIMARY OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
18; 6; 32; 0; 0; 3 | — |
| PRIMARY OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine |
0; 3; 4; 6; 0; 3 | — |
| PRIMARY OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) |
0; 7; 0; 1; 4 | — |
| PRIMARY OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides |
21; 6; 6; 0; 0; 0 | — |
| PRIMARY OL; Number of Participants With MAs in Urinalysis |
12; 0; 41; 28; 57; 35 | — |
| SECONDARY DB; Number of Participants With a New SLE Flare During the Initial 6 Months |
75; 36 | — |
| SECONDARY DB; Total Number of New SLE Flares Each Participant Experienced |
24; 10; 47; 21; 21; 10 | — |
| SECONDARY DB; Median Number of Days to the First Occurrence of a New SLE Flare |
107.0; 92.0 | — |
| SECONDARY DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline |
101; 44; 3; 2; 3; 1 | — |
| SECONDARY DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs |
0; 0; 110; 54; 24; 4 | — |
| SECONDARY DB; Number of Participants With Significant AEs of Special Interest |
71; 38; 1; 0; 4; 2 | — |
| SECONDARY DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
26; 11; 8; 2; 46; 30 | — |
| SECONDARY DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine |
2; 0; 3; 0; 2; 0 | — |
| SECONDARY DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total) |
1; 0; 1; 1; 0; 0 | — |
| SECONDARY DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides |
27; 10; 5; 1; 4; 1 | — |
| SECONDARY DB; Number of Participants With MAs in Urinalysis |
15; 9; 1; 2; 39; 18 | — |
| SECONDARY DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings |
— | — |
| SECONDARY DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment |
2 | — |
| SECONDARY OL; Number of Participants With a New SLE Flare |
— | — |
| SECONDARY OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline |
— | — |
| SECONDARY OL; Total Number of BILAG A Flares Each Participant Experienced |
— | — |
| SECONDARY OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent |
— | — |
| SECONDARY OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment |
30 | — |
Summary
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 participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- participants 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
- participants 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
- participants with active viral or bacterial infections
- participants with any other autoimmune disease as a main diagnosis
- Prior treatment with rituximab
Data sourced from ClinicalTrials.gov (NCT00119678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.