Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

Abbott

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338650

M06-808

CHOICE

Details and patient eligibility

About

The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient diagnosed with moderate to severe Crohn's Disease.
• Failed prior infliximab therapy.
• Patient is judged to be in generally good health as determined by the principal investigator.

Exclusion criteria

• Previous treatment with adalimumab.
• Patient considered by the investigator, for any reason, to be an unsuitable candidate

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)