An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis (OPAL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42477
• EU PAS number:
  EUPAS13986
• Study ID:
  42477
• Official title and acronym:
  An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis (OPAL)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  Czechia

  France

  Germany

  Greece

  Italy

  Korea, Republic of

  Spain

  United States
• Study description:
  This is an observational prospective long-term exposure registry of adult participants with moderate-to-severe ulcerative colitis. Two cohorts, a Simponi-exposed cohort and a comparator cohort treated with thiopurines, will be enrolled in study. Approximately 6,000 participants are planned for enrollment, with 3,000 participants in the Simponi-exposed cohort and 3,000 participants in the comparator cohort. Participants will receive treatments in a routine clinical setting as prescribed by their physician. After enrollment, during the 10-year follow-up period, a participant may stop his or her ulcerative colitis treatment regimen and switch to a new treatment regimen. Lymphoma incidence will be primarily assessed by a questionnaire that will be sent to the investigator to obtain complete medical information about each case. An expert panel of medical specialists with extensive experience in lymphoma will be convened to validate cases of lymphoma. Besides assessing the incidence of lymphoma, long-term safety will be evaluated by capturing other adverse events of interest and serious adverse events.
• Study status:
  Ongoing

Research institution and networks

Institutions

Johnson & Johnson

ICON Commersialisation & Outcomes (MAPI-ICON), ICON

Germany

Study timelines

Date when funding contract was signed

Planned: 26/02/2015

Actual: 26/02/2015

Study start date

Planned: 30/12/2016

Actual: 19/12/2016

Date of final study report

Planned: 27/08/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Biotech Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

Clinicaltrials.gov posting: NCT02808780