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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00119678




Registration number
NCT00119678
Ethics application status
Date submitted
30/06/2005
Date registered
14/07/2005
Date last updated
22/09/2014

Titles & IDs
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
Secondary ID [1] 0 0
IM101-042
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone
Treatment: Drugs - Abatacept

Active Comparator: Abatacept + Prednisone - Double Blind Period

Placebo Comparator: Placebo + Prednisone - Double Blind Period

Experimental: Abatacept - Open Label


Treatment: Drugs: Abatacept
Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months

Treatment: Drugs: Placebo
Injectable, intravenous, 0 mg, every 28 days, 12 months

Treatment: Drugs: Prednisone
Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months

Treatment: Drugs: Abatacept
Injectable, intravenous, 10 mg/kg, every 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare
Timepoint [1] 0 0
From start of corticosteroid taper to Day 365
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [3] 0 0
OL; Number of Participants With Significant AEs of Special Interest
Timepoint [3] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [4] 0 0
OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Timepoint [4] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [5] 0 0
OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Timepoint [5] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [7] 0 0
OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)
Timepoint [7] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [8] 0 0
OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Timepoint [8] 0 0
From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Primary outcome [9] 0 0
OL; Number of Participants With MAs in Urinalysis
Timepoint [9] 0 0
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 [1] 0 0
DB; Number of Participants With a New SLE Flare During the Initial 6 Months
Timepoint [1] 0 0
From start of corticosteroid taper to 6 months.
Secondary outcome [2] 0 0
DB; Total Number of New SLE Flares Each Participant Experienced
Timepoint [2] 0 0
From start of corticosteroid taper to Day 365
Secondary outcome [3] 0 0
DB; Median Number of Days to the First Occurrence of a New SLE Flare
Timepoint [3] 0 0
From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period
Secondary outcome [4] 0 0
DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline
Timepoint [4] 0 0
From start of study drug treatment to Day 365
Secondary outcome [5] 0 0
DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
DB; Number of Participants With Significant AEs of Special Interest
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
DB; Number of Participants With MAs in Urinalysis
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Timepoint [14] 0 0
From Day 1 to Day 365
Secondary outcome [15] 0 0
OL; Number of Participants With a New SLE Flare
Timepoint [15] 0 0
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 outcome [16] 0 0
OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline
Timepoint [16] 0 0
From start of study drug therapy in open-label period (Day 365) and on Day 729.
Secondary outcome [17] 0 0
OL; Total Number of BILAG A Flares Each Participant Experienced
Timepoint [17] 0 0
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 outcome [18] 0 0
OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent
Timepoint [18] 0 0
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 outcome [19] 0 0
OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Timepoint [19] 0 0
After the first dose of open-label period

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Cairns
Recruitment hospital [2] 0 0
Local Institution - Maroochydore
Recruitment hospital [3] 0 0
Local Institution - Clayton
Recruitment hospital [4] 0 0
Local Institution - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
Goias
Country [15] 0 0
Brazil
State/province [15] 0 0
Parana
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio De Janeiro
Country [17] 0 0
Brazil
State/province [17] 0 0
Sao Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Manitoba
Country [20] 0 0
France
State/province [20] 0 0
Bordeaux Cedex
Country [21] 0 0
France
State/province [21] 0 0
Montpellier Cedex 5
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 14
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Duesseldorf
Country [25] 0 0
Germany
State/province [25] 0 0
Freiburg
Country [26] 0 0
Italy
State/province [26] 0 0
Ferrara
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Sungdong-Gu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Mexico
State/province [29] 0 0
Distrito Federal
Country [30] 0 0
Mexico
State/province [30] 0 0
Michioacan
Country [31] 0 0
Mexico
State/province [31] 0 0
Aguascalientes
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
Ponce
Country [33] 0 0
South Africa
State/province [33] 0 0
Kwa Zulu Natal
Country [34] 0 0
South Africa
State/province [34] 0 0
Western Cape
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00119678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00119678