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

Abbott1,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Crohn's Disease

Interventions

adalimumabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (97)

Outcomes

Primary Outcomes

AEs, laboratory data, physical examinations and vital signs

Secondary Outcomes

Efficacy variables will be assessed from Outcomes Questionnaires

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Jonesboro, Arkansas, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Roseville, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Englewood, Colorado, United States

Unnamed facility

Wheat Ridge, Colorado, United States

Unnamed facility

Bridgeport, Connecticut, United States

Unnamed facility

Hamden, Connecticut, United States

Unnamed facility

Clearwater, Florida, United States

...and 87 more locations