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IBD-OPERA Database, UC Protocol (OPERA)

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ClinicalTrials.gov Identifier: NCT01708395
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : August 17, 2015
Janssen Services, LLC
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease
Inflammatory Bowel Disease

Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Prospective
Official Title: IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database
Study Start Date : October 2012
Primary Completion Date : March 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Cohort 1
First 50 patients
Cohort 2
2nd group of 50 patients

Primary Outcome Measures :
  1. Validity of patient self reporting [ Time Frame: 12 months ]
    The validity of patient self report on details of their ulcerative colitis compared to chart review. Validity is defined as a match between patient self report and medical records.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults over 18 years of age

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708395

United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Janssen Services, LLC

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01708395     History of Changes
Other Study ID Numbers: REMICADEIBD4007
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
Ulcerative colitis

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases