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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12607000003471
Date of registration:	02/01/2007
Prospective Registration:	Yes
Primary sponsor:	Bristol-Myers Squibb
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
Date of first enrolment:	01/02/2007
Target sample size:	586
Recruitment status:	Not yet recruiting
URL:	https://anzctr.org.au/ACTRN12607000003471.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;Type of endpoint: Safety/efficacy;
Phase:	Phase 3

Countries of recruitment
Australia

Contacts

Name:	Dr Miles Sparrow
Address:	Gastroenterology Department 8th Floor Eastern Health Clive Ward Building 16 Arnold Street Box Hill VIC 3128 Australia
Telephone:	+61 3 98950369
Email:	Miles.sparrow@med.monash.edu.au
Affiliation:

Name:	Dr Miles Sparrow
Address:	Gastroenterology Department 8th Floor Eastern Health Clive Ward Building 16 Arnold Street Box Hill VIC 3128 Australia
Telephone:	+61 3 98950369
Email:	Miles.sparrow@med.monash.edu.au
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: *Ulcerative colitis for at lease 3 months *Moderate to severe active ulcerative colitis *Inadequate response or intolerance to standard ulcerative colitis treatment.
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.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Ulcerative Colitis;
Ulcerative Colitis

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention(s)

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.

Primary Outcome(s)

Clinical response after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy as defined by reduction in Mayo score[A full Mayo or partial Mayo score will be calculated at each visit.]

Secondary Outcome(s)

Remission; Mucosal Healing at time point and with scoring system noted in Mayo score.[A full Mayo or partial Mayo score will be calculated at each visit.]

Secondary ID(s)

Bristol Myers Squibb (BMS): IM101-108

Source(s) of Monetary Support

Bristol-Myers Squibb

Secondary Sponsor(s)

Ethics review