IBD-OPERA Database, UC Protocol

NCT ID: NCT01708395

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-06-30

Brief Summary

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The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

First 50 patients

No interventions assigned to this group

Cohort 2

2nd group of 50 patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* MD documented diagnosis of ulcerative colitis
* current of past prescription for anti-TNF medication
* at least 18 years of age
* access to medical records to verify information
* 20% of participants will be patients diagnosed within 1 year of inclusion

Exclusion Criteria

* unwilling or unable to provide informed consent for study participation
* unable to access or use internet
* less than 18 years of age
* diagnosis of crohn's disease or IBD-U
* illiterate or does not possess minimum level of literacy required to complete questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Services, LLC

INDUSTRY

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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REMICADEIBD4007

Identifier Type: -

Identifier Source: org_study_id

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