Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000692639
Ethics application status
Approved
Date submitted
25/10/2005
Date registered
27/10/2005
Date last updated
27/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol IM101042: 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.
Scientific title
Protocol IM101042: 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.
Universal Trial Number (UTN)
Trial acronym
Not applicable.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE). 841 0
Condition category
Condition code
Inflammatory and Immune System 908 908 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Abatacept plus Prednisone or Prednisone equivalent for 12-month period OR placebo plus Prednisone or Prednisone equivalent for 12-month period.

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study.
Intervention code [1] 734 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1182 0
The primary objective of this study will be to assess the proportion of subjects with new clinical flare of Systemic Lupus Erythematosus (British Isles Lupus Assessment Group (BILAG) "A" or "B") during the 1 year double-blind treatment period.
Timepoint [1] 1182 0
Secondary outcome [1] 2159 0
1. Assess proportion of subjects with a new clinical flare of SLE (BILAG A or B)
Timepoint [1] 2159 0
Within the initial 6 months of the double-blind treatment period.
Secondary outcome [2] 2160 0
2. Evaluate the proportion of subjects who during the study experienced a BILAG A or B flare.
Timepoint [2] 2160 0

Eligibility
Key inclusion criteria
1. Subjects 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. 2. Stable dose of prednisone (<30mg) for at least one month.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects experiencing an active lupus flare in the kidney or central nervous systems. 2. Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study. 3. Subjects with active viral or bacterial infections. 4. Subjects with any other autoimmune disease as a main diagnosis. 5. Prior treatment with rituximab.

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)
Treatment allocated through central randomisation system by phone and fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated to randomly allocate treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1001 0
Commercial sector/Industry
Name [1] 1001 0
Bristol-Myers Squibb Australia
Country [1] 1001 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Australia
Address
Country
Australia
Secondary sponsor category [1] 862 0
None
Name [1] 862 0
Not applicable.
Address [1] 862 0
Country [1] 862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2311 0
Monash Medical Centre
Ethics committee address [1] 2311 0
Ethics committee country [1] 2311 0
Australia
Date submitted for ethics approval [1] 2311 0
Approval date [1] 2311 0
Ethics approval number [1] 2311 0
Ethics committee name [2] 2312 0
Austin Health
Ethics committee address [2] 2312 0
Ethics committee country [2] 2312 0
Australia
Date submitted for ethics approval [2] 2312 0
Approval date [2] 2312 0
Ethics approval number [2] 2312 0
Ethics committee name [3] 2313 0
Cabrini Medical Centre
Ethics committee address [3] 2313 0
Ethics committee country [3] 2313 0
Australia
Date submitted for ethics approval [3] 2313 0
Approval date [3] 2313 0
Ethics approval number [3] 2313 0
Ethics committee name [4] 2314 0
Sixth Avenue Specialist Centre
Ethics committee address [4] 2314 0
Ethics committee country [4] 2314 0
Australia
Date submitted for ethics approval [4] 2314 0
Approval date [4] 2314 0
Ethics approval number [4] 2314 0
Ethics committee name [5] 2315 0
Cairns Rheumatology
Ethics committee address [5] 2315 0
Ethics committee country [5] 2315 0
Australia
Date submitted for ethics approval [5] 2315 0
Approval date [5] 2315 0
Ethics approval number [5] 2315 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36158 0
Address 36158 0
Country 36158 0
Phone 36158 0
Fax 36158 0
Email 36158 0
Contact person for public queries
Name 9923 0
Associate Professor Geoff Littlejohn
Address 9923 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 9923 0
Australia
Phone 9923 0
+61 3 95943565
Fax 9923 0
+61 3 95946512
Email 9923 0
g.littlejohn@southernhealth.org.au
Contact person for scientific queries
Name 851 0
Associate Professor Geoff Littlejohn
Address 851 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 851 0
Australia
Phone 851 0
+61 3 95943565
Fax 851 0
+61 3 95946512
Email 851 0
g.littlejohn@southernhealth.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.