Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01083680

P10-278

Details and patient eligibility

About

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Full description

This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Enrollment: 4,107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Exclusion criteria

• Hypersensitivity against the drug or one of the other ingredients.

Trial design

4,107 participants in 1 patient group

Participants with Crohn's Disease (CD)

Description:

Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.