None listed
Conditions
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
Interventions
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.
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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed