Conditions: Crohn's Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 451
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 4 arms for induction period

2 arms for maintenance period arm 2: 4 arms for induction period

2 arms for maintenance period arm 3: 1 arm for open-label extension phase

Interventions: intervention 1: abatacept intervention 2: placebo intervention 3: abatacept
Intervention descriptions: intervention 1: Dextrose 5% in water, intravenous (IV).

Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;

3 mg/kg on days IP-1, IP-15,IP-29, IP-57;

\~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,

or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57.

Induction Period 3 months

Maintenance Period 12 months intervention 2: Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months intervention 3: \~10 mg/kg, every 28 days.

Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued

Protocol document: