Sponsor study identifier
observational
511
0 countries
N/A
Study Start
December 16, 2011
Actual (reported)Primary Completion
March 31, 2018
Actual (reported)Study Completion
March 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2011
Actual (reported)November 3, 2011
Actual (reported)December 16, 2011
Actual (reported)March 31, 2018
Actual (reported)March 31, 2018
Actual (reported)May 20, 2019
Actual (reported)Number of Participants With Adverse Events
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
From first dose of Humira up to 3 years
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
From first dose of Humira up to 3 years
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
From first dose of Humira up to 3 years
Change in WPAI: CD Presenteeism Over Time
From first dose of Humira up to 3 years
Change in WPAI: CD Overall Work Impairment Over Time
From first dose of Humira up to 3 years
Change in WPAI: CD Activity Impairment Over Time
From first dose of Humira up to 3 years
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.
AbbVie Inc.
AbbVie
511 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2011
First Posted
November 3, 2011
Study Start
December 16, 2011
Actual (reported)Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2018
Actual (reported)Study Completion
March 31, 2018
Actual (reported)Last Updated
May 20, 2019
Results First Posted
May 20, 2019
Record last verified: 2019-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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