The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000785606
Ethics application status
Approved
Date submitted
8/12/2005
Date registered
9/12/2005
Date last updated
9/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA
Scientific title
A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA
Secondary ID [1] 226 0
Bristol Myers Squibb: IM101-046
Universal Trial Number (UTN)
Trial acronym
IM101-046
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Undifferentiated Arthritis (UA) 944 0
Condition category
Condition code
Inflammatory and Immune System 1013 1013 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Abatacept for the first 6 months, then 18 months oberservation.
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention code [1] 793 0
Treatment: Drugs
Comparator / control treatment
Drug: Placebo for the first 6 months, then 18 months oberservation.
Control group
Placebo

Outcomes
Primary outcome [1] 1351 0
Proportion of subjects wih a diagnosis of Rheumatoid Arthritis by ARA criteria
Timepoint [1] 1351 0
At 12 months
Secondary outcome [1] 2410 0
Proportion of subjects with a diagnosis of RA by 1987 ARA criteria.
Timepoint [1] 2410 0
At 24 months.
Secondary outcome [2] 2411 0
The proportion of subjects with persistent symptomatic clinical synovitis.
Timepoint [2] 2411 0
At 6, 12, and 24 months.
Secondary outcome [3] 2412 0
The mean DAS 28 (crp) score.
Timepoint [3] 2412 0
At 6, 12, and 24 months.

Eligibility
Key inclusion criteria
Diagnosis of undifferentiated arthritis Clinical synovitis of two or more joints At least one but not more than three of the criteria for diagnosis of RA (1987). No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics. Duration of disease must be 18 months or less. Positive for antibodies against cyclic citrullinated peptides.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy. Men unwilling to use an adequate method of contraception. Active vasculitis of a major organ system. Severe or recurrent bacterial infection. History of cancer in the last five years except certain skin cancers. Herpes zoster that resolved less than 2 months prior to enrollment.

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, Randomisation will be stratified into two groups based on the presence or absence of erosions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1117 0
Commercial sector/Industry
Name [1] 1117 0
Bristol-Myers Squibb Australia
Address [1] 1117 0
Country [1] 1117 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Australia
Address
Country
Australia
Secondary sponsor category [1] 975 0
None
Name [1] 975 0
N/A
Address [1] 975 0
Country [1] 975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2429 0
Monash Medical Centre
Ethics committee address [1] 2429 0
Ethics committee country [1] 2429 0
Australia
Date submitted for ethics approval [1] 2429 0
Approval date [1] 2429 0
Ethics approval number [1] 2429 0
Ethics committee name [2] 2430 0
Cabrini Medical Centre
Ethics committee address [2] 2430 0
Ethics committee country [2] 2430 0
Australia
Date submitted for ethics approval [2] 2430 0
Approval date [2] 2430 0
Ethics approval number [2] 2430 0
Ethics committee name [3] 2431 0
Cairns Rheumatology
Ethics committee address [3] 2431 0
Ethics committee country [3] 2431 0
Australia
Date submitted for ethics approval [3] 2431 0
Approval date [3] 2431 0
Ethics approval number [3] 2431 0
Ethics committee name [4] 2432 0
Royal Perth Hospital
Ethics committee address [4] 2432 0
Ethics committee country [4] 2432 0
Australia
Date submitted for ethics approval [4] 2432 0
Approval date [4] 2432 0
Ethics approval number [4] 2432 0

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

Contacts
Principal investigator
Name 36261 0
Address 36261 0
Country 36261 0
Phone 36261 0
Fax 36261 0
Email 36261 0
Contact person for public queries
Name 9982 0
Associate Professor Geoff Littlejohn
Address 9982 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 9982 0
Australia
Phone 9982 0
+61 3 95943565
Fax 9982 0
+61 3 95946512
Email 9982 0
g.littlejohn@southernhealth.org.au
Contact person for scientific queries
Name 910 0
Associate Professor Geoff Littlejohn
Address 910 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 910 0
Australia
Phone 910 0
+61 3 95943565
Fax 910 0
+61 3 95946512
Email 910 0
g.littlejohn@southernhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary