ANZCTR - Registration

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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

Secondary ID [1]

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)

Condition category

Condition code

Inflammatory and Immune System

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]

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]

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]

On day 365.

Primary outcome [2]

Joint damage progression measured by radiographic evaluation using the Genantâ Modified Sharp total score

Timepoint [2]

At 12 months of treatment (Day 365).

Secondary outcome [1]

Compare the proportion of subjects with an ACR50 response.

Timepoint [1]

At month 12 (Day 365).

Secondary outcome [2]

Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response.

Timepoint [2]

At month 12 (Day 365).

Secondary outcome [3]

Compare the disease activity as measured by DAS 28 score.

Timepoint [3]

At month 12 (Day 365).

Secondary outcome [4]

Compare the improvement in physical function using the HAQ disability index.

Timepoint [4]

At month 12 (Day 365) and assess the improvement in physical function at month 24 (Day 729).

Secondary outcome [5]

Compare the improvement in health-related quality of life using SF-36.

Timepoint [5]

At month 12 (Day 365).

Secondary outcome [6]

Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing.

Timepoint [6]

At month 12 (Day 365).

Secondary outcome [7]

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]

At month 24 (Day 729).

Secondary outcome [8]

Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept.

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Bristol-Myers Squibb Australia

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Bristol-Myers Squibb Australia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Medical Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Cabrini Medical Centre

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Cairns Rheumatology

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Royal Perth Hospital

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Associate Professor Geoff Littlejohn

Address

Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Country

Australia

Phone

+61 3 95943565

Fax

+61 3 95946512

[email protected]

Contact person for scientific queries

Name

Associate Professor Geoff Littlejohn

Address

Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Country

Australia

Phone

+61 3 95943565

Fax

+61 3 95946512

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: A systematic review and network meta-analysis.	2017	https://dx.doi.org/10.1002/14651858.CD012657
Embase	Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: A systematic review and network meta-analysis.	2017	https://dx.doi.org/10.1002/14651858.CD012591

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically