Special Investigation on Long-term Treatment in Patients With Crohn's Disease
This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01464333
First received: November 1, 2011
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Crohn's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Special Investigation on Long-term Treatment in Patients With Crohn's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Number of patients with adverse events [ Time Frame: at month 6 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Number of patients with adverse events [ Time Frame: at year 1 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Number of patients with adverse events [ Time Frame: at year 1.5 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Number of patients with adverse events [ Time Frame: at year 2 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Number of patients with adverse events [ Time Frame: at year 2.5 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
- Number of patients with adverse events [ Time Frame: at year 3 ] [ Designated as safety issue: Yes ]Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Secondary Outcome Measures:
- Crohn's Disease Activity Index [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at year 1 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at year 1.5 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at year 2 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at year 2.5 ] [ Designated as safety issue: No ]
- Crohn's Disease Activity Index [ Time Frame: at year 3 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 1.5 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 2.5 ] [ Designated as safety issue: No ]
- Work Productivity and Activity Impairment Questionnaire [ Time Frame: at year 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Humira
those with an exposure
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens
Criteria
Inclusion Criteria:
Patients who meet the following criteria at baseline will be evaluated in the investigation;
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464333
Contacts
| Contact: AbbVie Japan PMOS Desk | +81-3-4588-4621 | abvj-pmos@abbvie.com |
| Contact: Toshiro Maeda | toshiro.maeda@abbvie.com |
Locations
| Japan | |
| Site Reference ID/Investigator# 81105 | Recruiting |
| Akita, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 81105 | |
| Site Reference ID/Investigator# 79700 | Recruiting |
| Chikushino, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79700 | |
| Site Reference ID/Investigator# 79643 | Recruiting |
| Fukuoka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79643 | |
| Site Reference ID/Investigator# 79644 | Recruiting |
| Fukuoka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79644 | |
| Site Reference ID/Investigator# 79694 | Recruiting |
| Gifu, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79694 | |
| Site Reference ID/Investigator# 79645 | Recruiting |
| Hamamatsu, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79645 | |
| Site Reference ID/Investigator# 79466 | Recruiting |
| Hamamatsu, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79466 | |
| Site Reference ID/Investigator# 79642 | Recruiting |
| Hirosaki, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79642 | |
| Site Reference ID/Investigator# 79477 | Recruiting |
| Hiroshima, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79477 | |
| Site Reference ID/Investigator# 79681 | Recruiting |
| Iwafune, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79681 | |
| Site Reference ID/Investigator# 79450 | Recruiting |
| Kagoshima, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79450 | |
| Site Reference ID/Investigator# 79675 | Recruiting |
| Kashiwa, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79675 | |
| Site Reference ID/Investigator# 79478 | Recruiting |
| Kashiwa, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79478 | |
| Site Reference ID/Investigator# 79693 | Recruiting |
| Kawagoe, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79693 | |
| Site Reference ID/Investigator# 79454 | Recruiting |
| Koriyama, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79454 | |
| Site Reference ID/Investigator# 79445 | Recruiting |
| Kumamoto, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79445 | |
| Site Reference ID/Investigator# 79636 | Recruiting |
| Kurashiki, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79636 | |
| Site Reference ID/Investigator# 79475 | Recruiting |
| Kyoto, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79475 | |
| Site Reference ID/Investigator# 79456 | Recruiting |
| Minato, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79456 | |
| Site Reference ID/Investigator# 68736 | Recruiting |
| Miyagi, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 68736 | |
| Site Reference ID/Investigator# 79446 | Recruiting |
| Morioka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79446 | |
| Site Reference ID/Investigator# 79656 | Recruiting |
| Nagasaki, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79656 | |
| Site Reference ID/Investigator# 79654 | Recruiting |
| Nagoya, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79654 | |
| Site Reference ID/Investigator# 79653 | Recruiting |
| Nagoya, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79653 | |
| Site Reference ID/Investigator# 79459 | Recruiting |
| Neyagawa, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79459 | |
| Site Reference ID/Investigator# 79465 | Recruiting |
| Nishinomiya, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79465 | |
| Site Reference ID/Investigator# 79695 | Recruiting |
| Oita, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79695 | |
| Site Reference ID/Investigator# 79677 | Recruiting |
| Oita, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79677 | |
| Site Reference ID/Investigator# 79479 | Recruiting |
| Okayama, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79479 | |
| Site Reference ID/Investigator# 79464 | Recruiting |
| Osaka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79464 | |
| Site Reference ID/Investigator# 79448 | Recruiting |
| Osaka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79448 | |
| Site Reference ID/Investigator# 79449 | Recruiting |
| Osaka, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79449 | |
| Site Reference ID/Investigator# 79657 | Recruiting |
| Osakasayama, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79657 | |
| Site Reference ID/Investigator# 79673 | Recruiting |
| Otsu, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79673 | |
| Site Reference ID/Investigator# 79674 | Recruiting |
| Saga, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79674 | |
| Site Reference ID/Investigator# 79455 | Recruiting |
| Saitama, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79455 | |
| Site Reference ID/Investigator# 79476 | Recruiting |
| Sakura, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79476 | |
| Site Reference ID/Investigator# 79453 | Recruiting |
| Shunan, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79453 | |
| Site Reference ID/Investigator# 79634 | Recruiting |
| Suita, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79634 | |
| Site Reference ID/Investigator# 79451 | Recruiting |
| Takamatsu, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79451 | |
| Site Reference ID/Investigator# 79641 | Recruiting |
| Tokyo, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79641 | |
| Site Reference ID/Investigator# 79699 | Recruiting |
| Tokyo, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79699 | |
| Site Reference ID/Investigator# 81102 | Recruiting |
| Toyohashi, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 81102 | |
| Site Reference ID/Investigator# 81100 | Recruiting |
| Toyota, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 81100 | |
| Site Reference ID/Investigator# 79458 | Recruiting |
| Yokkaichi, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79458 | |
| Site Reference ID/Investigator# 79473 | Recruiting |
| Yokohama, Japan | |
| Principal Investigator: Site Reference ID/Investigator# 79473 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Toshiro Maeda | AbbVie GK |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01464333 History of Changes |
| Other Study ID Numbers: | P13-170 |
| Study First Received: | November 1, 2011 |
| Last Updated: | April 22, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AbbVie:
|
Crohn's Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013