Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00430677




Registration number
NCT00430677
Ethics application status
Date submitted
1/02/2007
Date registered
2/02/2007
Date last updated
20/03/2015

Titles & IDs
Public title
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Scientific title
A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 0 0
IM101-075
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 - Corticosteroids (prednisone or prednisolone)
Treatment: Drugs - Abatacept
Treatment: Drugs - Abatacept
Treatment: Drugs - Mycophenolate mofetil (MMF)
Treatment: Drugs - Abatacept

Experimental: Abatacept 30 mg/kg+Corticosteroids+MMF - Short-term Period

Experimental: Abatacept 10 mg/kg+Corticosteroids+MMF - Short-term Period

Experimental: Placebo+Corticosteroids+MMF - Short-term Period

Experimental: Abatacept 10mg/kg - Long-term Extension Period


Treatment: Drugs: Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily

Treatment: Drugs: Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days

Treatment: Drugs: Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days

Treatment: Drugs: Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily

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

Outcomes
Primary outcome [1] 0 0
Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
Timepoint [1] 0 0
Day 1 (randomization) to 12 months.
Secondary outcome [1] 0 0
Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period
Timepoint [1] 0 0
Day 1 to 12 months
Secondary outcome [2] 0 0
Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period
Timepoint [2] 0 0
At Month 12 from Day 1
Secondary outcome [3] 0 0
Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
Timepoint [3] 0 0
Day 1 (randomization) to 12 months.
Secondary outcome [4] 0 0
Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
Timepoint [4] 0 0
At Month 12 from Day 1
Secondary outcome [5] 0 0
Number of Months CRR Was Maintained During Short-term Period
Timepoint [5] 0 0
Day 1 (randomization) to 12 Months
Secondary outcome [6] 0 0
Baseline Renal Function Over Time During Short-term Period
Timepoint [6] 0 0
Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Secondary outcome [7] 0 0
Change in Renal Function From Baseline Over Time During Short-term Period
Timepoint [7] 0 0
Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Secondary outcome [8] 0 0
Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period
Timepoint [8] 0 0
Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)
Secondary outcome [9] 0 0
Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
Timepoint [9] 0 0
Month 12
Secondary outcome [10] 0 0
Change in SLICC/ACR Damage Index From Baseline During Short-term Period
Timepoint [10] 0 0
Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)
Secondary outcome [11] 0 0
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period
Timepoint [11] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [12] 0 0
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period
Timepoint [12] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [13] 0 0
Baseline Mental Component Summary of the Short SF-36 During Short-term Period
Timepoint [13] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [14] 0 0
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period
Timepoint [14] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [15] 0 0
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period
Timepoint [15] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [16] 0 0
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period
Timepoint [16] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [17] 0 0
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period
Timepoint [17] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [18] 0 0
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period
Timepoint [18] 0 0
Baseline (Day 1), Days 85, 169, 253, and 365
Secondary outcome [19] 0 0
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period
Timepoint [19] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [20] 0 0
Participants With AEs of Special Interest During the Short-term Period
Timepoint [20] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [21] 0 0
Participants With Marked Hematology Abnormalities During the Short-term Period
Timepoint [21] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [22] 0 0
Participants With Marked Laboratory Abnormalities During the Short-term Period
Timepoint [22] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [23] 0 0
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period
Timepoint [23] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [24] 0 0
Participants With Marked Abnormalities Urinalysis During the Short-term Period
Timepoint [24] 0 0
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Secondary outcome [25] 0 0
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)
Timepoint [25] 0 0
0 - 12 Months
Secondary outcome [26] 0 0
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)
Timepoint [26] 0 0
0 - 12 Months
Secondary outcome [27] 0 0
Vital Signs Summary During the Short-term Period: Heart Rate
Timepoint [27] 0 0
0 - 12 Months
Secondary outcome [28] 0 0
Vital Signs Summary During the Short-term Period: Temperature
Timepoint [28] 0 0
0 - 12 Months
Secondary outcome [29] 0 0
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period
Timepoint [29] 0 0
Day 169, Day 365
Secondary outcome [30] 0 0
Baseline Quantitative Immunoglobulins During the Short-term Period
Timepoint [30] 0 0
Baseline (Day 1)
Secondary outcome [31] 0 0
Change in Quantitative Immunoglobulin From Baseline During Short-term Period
Timepoint [31] 0 0
Day 365
Secondary outcome [32] 0 0
Number of Participants Achieving Complete Response by ACCESS Definition
Timepoint [32] 0 0
End of short-term period (Day 365) to termination of the long-term extension period
Secondary outcome [33] 0 0
Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis
Timepoint [33] 0 0
At Day 365 (end of Short-term Period) and Day 645
Secondary outcome [34] 0 0
Mean Change From Baseline in SLICC/ACR Damage Index
Timepoint [34] 0 0
Day 365 to termination of the long-term extension phase
Secondary outcome [35] 0 0
Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period
Timepoint [35] 0 0
From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.
Secondary outcome [36] 0 0
Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period
Timepoint [36] 0 0
Day 365 to end of long-term extension period
Secondary outcome [37] 0 0
Number of Participants Achieving Renal Response
Timepoint [37] 0 0
At Day 365 (end of short-term period) and Day 645
Secondary outcome [38] 0 0
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period
Timepoint [38] 0 0
From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Secondary outcome [39] 0 0
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
Timepoint [39] 0 0
From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Secondary outcome [40] 0 0
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
Timepoint [40] 0 0
From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period

Eligibility
Key inclusion criteria
* Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
* Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification criteria [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but =12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range.
* A stable serum creatinine =3 mg/dL
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with a rise in serum creatinine of =1 mg/dL within 1 month prior to the screening visit
* Subjects with drug-induced SLE, as opposed to idiopathic SLE
* Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
* Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS])
* Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
* Subjects who have received treatment with rituximab < 6 months prior to the screening visit

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
423
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Liverpool
Recruitment hospital [2] 0 0
Local Institution - Clayton
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
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
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Tucuman
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Brazil
State/province [17] 0 0
Goias
Country [18] 0 0
Brazil
State/province [18] 0 0
Parana
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio Grande Do Sul
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio De Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Guangdong
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Shanxi
Country [30] 0 0
France
State/province [30] 0 0
Creteil Cedex
Country [31] 0 0
France
State/province [31] 0 0
Paris Cedex 13
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg Cedex
Country [33] 0 0
France
State/province [33] 0 0
Toulouse Cedex 4
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Hong Kong
Country [35] 0 0
India
State/province [35] 0 0
Ahmedabad
Country [36] 0 0
India
State/province [36] 0 0
Andhra Pradesh
Country [37] 0 0
India
State/province [37] 0 0
Gujarat
Country [38] 0 0
India
State/province [38] 0 0
Karnataka
Country [39] 0 0
India
State/province [39] 0 0
Kerala
Country [40] 0 0
India
State/province [40] 0 0
Maharajhsra
Country [41] 0 0
India
State/province [41] 0 0
Hyderabad
Country [42] 0 0
India
State/province [42] 0 0
Visakhapatnam
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Sungdong-Gu
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Mexico
State/province [45] 0 0
Distrito Federal
Country [46] 0 0
Mexico
State/province [46] 0 0
Estado De Mexico
Country [47] 0 0
Mexico
State/province [47] 0 0
Jalisco
Country [48] 0 0
Mexico
State/province [48] 0 0
Nuevo Leon
Country [49] 0 0
Mexico
State/province [49] 0 0
Yucatan
Country [50] 0 0
Mexico
State/province [50] 0 0
Aguascalientes
Country [51] 0 0
Mexico
State/province [51] 0 0
San Luis Potosi
Country [52] 0 0
Poland
State/province [52] 0 0
Bydgoszcz
Country [53] 0 0
Poland
State/province [53] 0 0
Gdansk
Country [54] 0 0
Poland
State/province [54] 0 0
Wroclaw
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Ekaterinburg
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Moscow
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Yaroslaval
Country [58] 0 0
South Africa
State/province [58] 0 0
Gauteng
Country [59] 0 0
South Africa
State/province [59] 0 0
Western Cape
Country [60] 0 0
Taiwan
State/province [60] 0 0
Kaohsiung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taichung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taoyuan
Country [64] 0 0
Turkey
State/province [64] 0 0
Gaziantep
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cambridgeshire
Country [66] 0 0
United Kingdom
State/province [66] 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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00430677