Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

NCT ID: NCT01464333

Last Updated: 2019-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

511 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-16

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Humira

Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

No interventions assigned to this group

Eligibility Criteria

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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

* None.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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P13-170

Identifier Type: -

Identifier Source: org_study_id

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