A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00524537

P06-134

Details and patient eligibility

About

The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.

Enrollment: 5,025 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbvie sponsored investigational Crohn's disease (CD) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
• Subjects who were participants in AbbVie sponsored investigational Crohn's CD trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
• Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
• Subjects willing to consent to data being collected and provided to AbbVie.
• Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.

Exclusion criteria

• Subjects should not be enrolled if they cannot be treated in accordance with the local product label.

Trial design

5,025 participants in 1 patient group

Adalimumab (Humira) Treatment

Description:

Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.