IBD-OPERA Database, UC Protocol (OPERA)

This study has been completed.
Janssen Services, LLC
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
First received: October 15, 2012
Last updated: August 14, 2015
Last verified: August 2015
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.

Inflammatory Bowel Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Validity of patient self reporting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Enrollment: 50
Study Start Date: October 2012
Study Completion Date: June 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Cohort 1
First 50 patients
Cohort 2
2nd group of 50 patients


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01708395     History of Changes
Other Study ID Numbers: REMICADEIBD4007 
Study First Received: October 15, 2012
Last Updated: August 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Ulcerative colitis

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

ClinicalTrials.gov processed this record on April 27, 2016