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

Crohn's Disease Clinical Trial

Official title:

A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338650
• Other study ID #: M06-808
• Secondary ID: CHOICE
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2006
• Last updated: November 28, 2007
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• adalimumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory data, physical examinations and vital signs
Secondary	Efficacy variables will be assessed from Outcomes Questionnaires