A Study of Abatacept in Patients With Active Crohn’s Disease

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.

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

Conditions

Crohn’s Disease

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Reduction in Crohn’s Disease Activity Index to meet clinical response criteria [Time Frame: at 8 weeks and 12 weeks during induction and at 12 months during maintenance]

Secondary Outcome Measures:

• Reduction in Crohn’s Disease Activity Index to meet clinical remission criteria [Time Frame: at 8 weeks and 12 weeks during induction and at 12 months during maintenance]

Study Start

December 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 18 years or older
• 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

Total Enrolment

689

Contact Details

Locations:

• Garran, Australian Capital Territory, 2605, Australia; Recruiting
• Camperdown, New South Wales, 2050, Australia; Recruiting
• Herston, Queensland, 4029, Australia; Recruiting
• South Brisbane, Queensland, 4101, Australia; Recruiting
• Bedford Park, South Australia, 5042, Australia; Recruiting
• Launceston, Tasmania, 7250, Australia; Recruiting
• Fitzroy, Victoria, 3065 VIC, Australia; Recruiting
• Box Hill, Victoria, 3128, Australia; Recruiting
• South Ballarat, Victoria, 3350, Australia; Recruiting
• Fremantle, Western Australia, 6160, Australia; Recruiting

For more information, see the Bristol-Myers Squibb Clinical Trial Registry