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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: abatacept; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406653

IM101-084

Details and patient eligibility

About

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.

Enrollment: 451 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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451 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

4 arms for induction period 2 arms for maintenance period

Treatment:

Drug: abatacept

Drug: abatacept

2

Placebo Comparator group

Description:

4 arms for induction period 2 arms for maintenance period

Treatment:

Drug: placebo

abatacept

Other group

Description:

1 arm for open-label extension phase

Treatment:

Drug: abatacept

Drug: abatacept