Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000003471
Ethics application status
Not yet submitted
Date submitted
20/12/2006
Date registered
2/01/2007
Date last updated
2/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 3 Study of Abatacept in Patients With Active Ulcerative Colitis
Scientific title
A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Secondary ID [1] 325 0
Bristol Myers Squibb (BMS): IM101-108
Universal Trial Number (UTN)
Trial acronym
IM101-108
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 1506 0
Condition category
Condition code
Oral and Gastrointestinal 1604 1604 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Intravenous Abatacept 10mg/kg once a fortnight for the first month and then once a month from then on. Some subjects will recieve 30mg/kg for the first two doses.
Participants will be randsomised to be dosed with either Abatacept or placebo for the first 12 weeks. All participants who respond to treatment as per the protocol definition will then be randomised again to either placebo or abatacept for 12 months of treatment. All non responders will be offered open label abtacept for 1 year.
All subjects who disease is not controlled will be considered for either discontinuation or open label treatment if not already being dosed with this.
Intervention code [1] 1514 0
Treatment: Drugs
Comparator / control treatment
First stage: Placebo 12 weeks. Second stage: Placebo 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 2213 0
Clinical response after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy as defined by reduction in Mayo score
Timepoint [1] 2213 0
A full Mayo or partial Mayo score will be calculated at each visit.
Secondary outcome [1] 3857 0
Remission; Mucosal Healing at time point and with scoring system noted in Mayo score.
Timepoint [1] 3857 0
A full Mayo or partial Mayo score will be calculated at each visit.

Eligibility
Key inclusion criteria
*Ulcerative colitis for at lease 3 months *Moderate to severe active ulcerative colitis *Inadequate response or intolerance to standard ulcerative colitis treatment.
Minimum age
18 Years
Maximum age
Not stated
Sex
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 for the entire study period and for up to 10 weeks after the study.

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)
Stratified allocation. Based on previous response to anti Tumor necrosis factor (TNF) therapy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cross over dependant on response to therapy. All persons involved in the study except the safety monitoring board and the data analyst are blinded to allocation
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
586
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1748 0
Commercial sector/Industry
Name [1] 1748 0
Bristol-Myers Squibb
Country [1] 1748 0
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
United States of America
Secondary sponsor category [1] 1545 0
None
Name [1] 1545 0
n/a
Address [1] 1545 0
Country [1] 1545 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3236 0
Flinders Medical Centre
Ethics committee address [1] 3236 0
Ethics committee country [1] 3236 0
Australia
Date submitted for ethics approval [1] 3236 0
Approval date [1] 3236 0
Ethics approval number [1] 3236 0
Ethics committee name [2] 3237 0
St Vincents
Ethics committee address [2] 3237 0
Ethics committee country [2] 3237 0
Australia
Date submitted for ethics approval [2] 3237 0
Approval date [2] 3237 0
Ethics approval number [2] 3237 0
Ethics committee name [3] 3238 0
Mater Adult Hospital
Ethics committee address [3] 3238 0
Ethics committee country [3] 3238 0
Australia
Date submitted for ethics approval [3] 3238 0
Approval date [3] 3238 0
Ethics approval number [3] 3238 0
Ethics committee name [4] 3239 0
Box Hill Hospital
Ethics committee address [4] 3239 0
Ethics committee country [4] 3239 0
Australia
Date submitted for ethics approval [4] 3239 0
Approval date [4] 3239 0
Ethics approval number [4] 3239 0
Ethics committee name [5] 3240 0
Ballarat Base Hospital
Ethics committee address [5] 3240 0
Ethics committee country [5] 3240 0
Australia
Date submitted for ethics approval [5] 3240 0
Approval date [5] 3240 0
Ethics approval number [5] 3240 0
Ethics committee name [6] 3241 0
Fremantle Hospital
Ethics committee address [6] 3241 0
Ethics committee country [6] 3241 0
Australia
Date submitted for ethics approval [6] 3241 0
Approval date [6] 3241 0
Ethics approval number [6] 3241 0
Ethics committee name [7] 3242 0
Launceston General Hospital
Ethics committee address [7] 3242 0
Ethics committee country [7] 3242 0
Australia
Date submitted for ethics approval [7] 3242 0
Approval date [7] 3242 0
Ethics approval number [7] 3242 0
Ethics committee name [8] 3243 0
The Canberra hospital
Ethics committee address [8] 3243 0
Ethics committee country [8] 3243 0
Australia
Date submitted for ethics approval [8] 3243 0
Approval date [8] 3243 0
Ethics approval number [8] 3243 0
Ethics committee name [9] 3244 0
Royal Brisbane Hospital
Ethics committee address [9] 3244 0
Ethics committee country [9] 3244 0
Australia
Date submitted for ethics approval [9] 3244 0
Approval date [9] 3244 0
Ethics approval number [9] 3244 0
Ethics committee name [10] 3245 0
Royal Prince Alfred Hospital
Ethics committee address [10] 3245 0
Ethics committee country [10] 3245 0
Australia
Date submitted for ethics approval [10] 3245 0
Approval date [10] 3245 0
Ethics approval number [10] 3245 0

Summary
Brief summary
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27448 0
Address 27448 0
Country 27448 0
Phone 27448 0
Fax 27448 0
Email 27448 0
Contact person for public queries
Name 10703 0
Dr Miles Sparrow
Address 10703 0
Gastroenterology Department
8th Floor
Eastern Health
Clive Ward Building
16 Arnold Street
Box Hill VIC 3128
Country 10703 0
Australia
Phone 10703 0
+61 3 98950369
Fax 10703 0
+61 3 98950353
Email 10703 0
Miles.sparrow@med.monash.edu.au
Contact person for scientific queries
Name 1631 0
Dr Miles Sparrow
Address 1631 0
Gastroenterology Department
8th Floor
Eastern Health
Clive Ward Building
16 Arnold Street
Box Hill VIC 3128
Country 1631 0
Australia
Phone 1631 0
+61 3 98950369
Fax 1631 0
+61 3 98950353
Email 1631 0
Miles.sparrow@med.monash.edu.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

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