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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00119678
• Date of registration: 30/06/2005
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
• Scientific 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
• Date of first enrolment: September 2005
• Target sample size: 183
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00119678
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Korea, Republic of, Mexico, Puerto Rico, South Africa, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Abatacept

Drug: Prednisone

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

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 [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

OL; Number of Participants With Significant AEs of Special Interest [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare [Time Frame: From start of corticosteroid taper to Day 365]

OL; Number of Participants With MAs in Urinalysis [Time Frame: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

Secondary Outcome(s)

DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

OL; Number of Participants With a New SLE Flare [Time Frame: From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

DB; Median Number of Days to the First Occurrence of a New SLE Flare [Time Frame: From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period]

DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

DB; Number of Participants With a New SLE Flare During the Initial 6 Months [Time Frame: From start of corticosteroid taper to 6 months.]

DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment [Time Frame: From Day 1 to Day 365]

DB; Total Number of New SLE Flares Each Participant Experienced [Time Frame: From start of corticosteroid taper to Day 365]

DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total) [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent [Time Frame: From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

DB; Number of Participants With MAs in Urinalysis [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline [Time Frame: From start of study drug treatment to Day 365]

DB; Number of Participants With Significant AEs of Special Interest [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline [Time Frame: From start of study drug therapy in open-label period (Day 365) and on Day 729.]

OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment [Time Frame: After the first dose of open-label period]

DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count [Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier]

OL; Total Number of BILAG A Flares Each Participant Experienced [Time Frame: From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

Secondary ID(s)

IM101-042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00119678