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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338650

Enrollment

1000

Registered

2006-06-20

Start date

2006-06-30

Completion date

2007-05-31

Last updated

2007-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief 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

Interventions

DRUGadalimumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
AEs, laboratory data, physical examinations and vital signs	—

Secondary

Measure	Time frame
Efficacy variables will be assessed from Outcomes Questionnaires	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026