Not Yet RecruitingPhase 3ACTRN12607000002482

A Phase 3 Study of Abatacept in Patients With Active Crohn's Disease

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 Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Sponsor

Bristol-Myers Squibb

Enrollment

689 participants

Start Date

Feb 1, 2007

Study Type

Interventional

Conditions

Crohns Disease

Summary

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Have had Crohn's Disease for at least 3 months *moderate to severely active Crohn's Disease *have had an inadequate response or intolerance to other Crohn's Disease treatments.

Exclusion Criteria1

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.

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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 randsomi

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.