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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AZATHIOPRINE

  GOLIMUMAB

  MERCAPTOPURINE MONOHYDRATE
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  The primary objective of this study is to compare the incidence of lymphoma in adult patients with moderate-to-severe ulcerative colitis who are treated with golimumab versus those treated with thiopurines
• Outcomes:
  Incidence of Lymphoma Time Frame: 10 years Incidence was calculated as number of participants with newly diagnosed lymphoma during registry in each cohort. -Relative Risk of Lymphoma (ratio of the rate of lymphoma events in participants in each cohort) -Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious -Clinical Disease Status as assessed by Partial Mayo Score -SIBDQ Score -EQ-5D Score -WPAI-UC -TSQM -Health care utilization
• Data analysis plan:
  The incidence of validated outcomes of lymphoma, rates per 100 patient-years, and the corresponding 95% CIs will be summarized and compared between the Simponi-exposed cohort and the comparator cohort. To rule out a clinically meaningful increase in the lymphoma rate in the Simponi-exposed cohort that exceeds the lymphoma rate in the thiopurine-exposed cohort, hazard ratios and 95% CIs for lymphoma will be estimated using the Cox proportional hazards regression analysis, adjusting for potential confounding variables.

Documents

Study, other information

33949_OPAL_Site List DrugDev Report_01Aug2023

OPAL General Region and Site report 24 July 2018

Primary outcome measures

Secondary outcome measures