Overview

This trial is active, not recruiting.

Condition crohn's disease
Sponsor AbbVie (prior sponsor, Abbott)
Start date December 2011
End date May 2016
Trial size 500 participants
Trial identifier NCT01464333, P13-170

Summary

This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
those with an exposure

Primary Outcomes

Measure
Number of patients with adverse events
time frame: at month 6
Number of patients with adverse events
time frame: at year 1
Number of patients with adverse events
time frame: at year 1.5
Number of patients with adverse events
time frame: at year 2
Number of patients with adverse events
time frame: at year 2.5
Number of patients with adverse events
time frame: at year 3

Secondary Outcomes

Measure
Crohn's Disease Activity Index
time frame: at week 4
Crohn's Disease Activity Index
time frame: at month 3
Crohn's Disease Activity Index
time frame: at month 6
Crohn's Disease Activity Index
time frame: at year 1
Crohn's Disease Activity Index
time frame: at year 1.5
Crohn's Disease Activity Index
time frame: at year 2
Crohn's Disease Activity Index
time frame: at year 2.5
Crohn's Disease Activity Index
time frame: at year 3
Work Productivity and Activity Impairment Questionnaire
time frame: at week 4
Work Productivity and Activity Impairment Questionnaire
time frame: at month 3
Work Productivity and Activity Impairment Questionnaire
time frame: at month 6
Work Productivity and Activity Impairment Questionnaire
time frame: at year 1
Work Productivity and Activity Impairment Questionnaire
time frame: at year 1.5
Work Productivity and Activity Impairment Questionnaire
time frame: at year 2
Work Productivity and Activity Impairment Questionnaire
time frame: at year 2.5
Work Productivity and Activity Impairment Questionnaire
time frame: at year 3

Eligibility Criteria

Male or female participants from 16 years up to 99 years old.

Inclusion Criteria: - Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen - Patients with no past- or present malignant tumors - Patients who are not currently receiving Humira Exclusion Criteria: - Contraindications according to the Package Insert - Patients who have serious infections - Patients who have tuberculosis - Patients with a history of hypersensitivity to any ingredient of Humira - Patients who have demyelinating disease or with a history of demyelinating disease - Patients who have congestive cardiac failure

Additional Information

Official title Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by AbbVie.