Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)
1 other identifier
observational
511
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedStudy Start
First participant enrolled
December 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedResults Posted
Study results publicly available
May 20, 2019
CompletedMay 20, 2019
February 1, 2019
6.3 years
November 1, 2011
February 19, 2019
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Eligibility Criteria
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.
You may qualify if:
- 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
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
November 3, 2011
Study Start
December 16, 2011
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
May 20, 2019
Results First Posted
May 20, 2019
Record last verified: 2019-02