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Trial registered on ANZCTR


Registration number
ACTRN12605000784617
Ethics application status
Approved
Date submitted
8/12/2005
Date registered
9/12/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate
Scientific title
A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate
Secondary ID [1] 225 0
Bristol Myers Squibb: IM101-023
Universal Trial Number (UTN)
Trial acronym
IM101-023
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 943 0
Condition category
Condition code
Inflammatory and Immune System 1012 1012 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Abatacept plus methotrexate for the first 12 months. Month 12 to 24, subjects previously treated with Abatacept plus methotrexate remain on this same treatment.
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention code [1] 792 0
Treatment: Drugs
Comparator / control treatment
Drug: Placebo plus methotrexate for the first 12 months. Month 12 to 24 subjects previously dosed with placebo plus methotrexate change to Abatacept plus methotrexate.
Control group
Placebo

Outcomes
Primary outcome [1] 1349 0
The proportion of subjects who achieve remission in 12 months of treatment as defined by a DAS 28 score less that 2.6.
Timepoint [1] 1349 0
On day 365.
Primary outcome [2] 1350 0
Joint damage progression measured by radiographic evaluation using the Genantâ Modified Sharp total score
Timepoint [2] 1350 0
At 12 months of treatment (Day 365).
Secondary outcome [1] 2402 0
Compare the proportion of subjects with an ACR50 response.
Timepoint [1] 2402 0
At month 12 (Day 365).
Secondary outcome [2] 2403 0
Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response.
Timepoint [2] 2403 0
At month 12 (Day 365).
Secondary outcome [3] 2404 0
Compare the disease activity as measured by DAS 28 score.
Timepoint [3] 2404 0
At month 12 (Day 365).
Secondary outcome [4] 2405 0
Compare the improvement in physical function using the HAQ disability index.
Timepoint [4] 2405 0
At month 12 (Day 365) and assess the improvement in physical function at month 24 (Day 729).
Secondary outcome [5] 2406 0
Compare the improvement in health-related quality of life using SF-36.
Timepoint [5] 2406 0
At month 12 (Day 365).
Secondary outcome [6] 2407 0
Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing.
Timepoint [6] 2407 0
At month 12 (Day 365).
Secondary outcome [7] 2408 0
Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score.
Timepoint [7] 2408 0
At month 24 (Day 729).
Secondary outcome [8] 2409 0
Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept.
Timepoint [8] 2409 0

Eligibility
Key inclusion criteria
Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray. CRP >= 8.0 mg/L Rheumatoid factor or anti CCP positive.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women and men who are not willing to use birth control Diagnosed with other rheumatic disease History of cancer within 5 years Active tuberculosis Treatment with another investigation drug within 28 days Active bacterial or viral infection.

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
Other
Other design features
Parallel design followed by crossover design for placebo only.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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] 1116 0
Commercial sector/Industry
Name [1] 1116 0
Bristol-Myers Squibb Australia
Address [1] 1116 0
Country [1] 1116 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Australia
Address
Country
Australia
Secondary sponsor category [1] 974 0
None
Name [1] 974 0
N/A
Address [1] 974 0
Country [1] 974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2425 0
Monash Medical Centre
Ethics committee address [1] 2425 0
Ethics committee country [1] 2425 0
Australia
Date submitted for ethics approval [1] 2425 0
Approval date [1] 2425 0
Ethics approval number [1] 2425 0
Ethics committee name [2] 2426 0
Cabrini Medical Centre
Ethics committee address [2] 2426 0
Ethics committee country [2] 2426 0
Australia
Date submitted for ethics approval [2] 2426 0
Approval date [2] 2426 0
Ethics approval number [2] 2426 0
Ethics committee name [3] 2427 0
Cairns Rheumatology
Ethics committee address [3] 2427 0
Ethics committee country [3] 2427 0
Australia
Date submitted for ethics approval [3] 2427 0
Approval date [3] 2427 0
Ethics approval number [3] 2427 0
Ethics committee name [4] 2428 0
Royal Perth Hospital
Ethics committee address [4] 2428 0
Ethics committee country [4] 2428 0
Australia
Date submitted for ethics approval [4] 2428 0
Approval date [4] 2428 0
Ethics approval number [4] 2428 0

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

Contacts
Principal investigator
Name 35202 0
Address 35202 0
Country 35202 0
Phone 35202 0
Fax 35202 0
Email 35202 0
Contact person for public queries
Name 9981 0
Associate Professor Geoff Littlejohn
Address 9981 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 9981 0
Australia
Phone 9981 0
+61 3 95943565
Fax 9981 0
+61 3 95946512
Email 9981 0
g.littlejohn@southernhealth.org.au
Contact person for scientific queries
Name 909 0
Associate Professor Geoff Littlejohn
Address 909 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 909 0
Australia
Phone 909 0
+61 3 95943565
Fax 909 0
+61 3 95946512
Email 909 0
g.littlejohn@southernhealth.org.au

No information has been provided regarding IPD availability
Summary results
No Results