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

June 4, 2026 updated by: Janssen Biotech, Inc.

Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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 Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
      • Sankt Poelten Noe, Austria
      • Vienna, Austria
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Ontario
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
  • Czechia
      • Pilsen, Czechia
  • France
      • Clermont-Ferrand, France
      • Clichy, France
      • Créteil, France
      • Grenoble, France
      • Montpellier, France
      • Nice, France
      • Pierre-Bénite, France
      • Saint-Priest-en-Jarez, France
      • Strasbourg, France
  • Germany
      • Berlin, Germany
      • Dessau Roblau, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Kiel, Germany
      • Leipzig, Germany
      • Ludwigshafen, Germany
      • Lyneburg, Germany
      • München, Germany
      • Saarbrücken, Germany
  • Greece
      • Athens, Greece
      • Heraklion, Greece
      • Ioannina, Greece
      • Thessaloniki, Greece
  • South Korea
      • Busan, South Korea
      • Gyeonggi-do, South Korea
      • Seongnam-si, South Korea
      • Seoul, South Korea
  • Spain
      • A Coruña, Spain
      • Barcelona, Spain
      • Córdoba, Spain
      • Fuenlabrada, Spain
      • Huelva, Spain
      • Madrid, Spain
      • Majadahonda, Spain
      • San Sebastián de los Reyes, Spain
      • Valencia, Spain
      • Vigo, Spain
      • Zaragoza, Spain
  • United States
    • California
      • Murrieta, California, United States
      • Rialto, California, United States
      • Ventura, California, United States
    • Florida
      • Coral Gables, Florida, United States
      • Fort Myers, Florida, United States
      • Lake Worth, Florida, United States
      • Lauderdale Lakes, Florida, United States
      • Miami, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Suwanee, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Ohio
      • Sylvania, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Lansdowne Town Center, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed

Description

Inclusion Criteria:

  • Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past

  • For enrollment into the Simponi-exposed cohort meets one of the following:

    1. The participant is currently receiving Simponi ,or
    2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
    3. The participant is scheduled to receive Simponi within 30 days after enrollment

  • For Thiopurine cohort:

    1. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
    2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
    3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

Exclusion Criteria:

  • Participants who cannot be treated with Simponi or thiopurines
  • Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment
  • Participants currently receiving an investigational or biologic agent other than Simponi
  • Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Simponi-exposed cohort
Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment.
Thiopurine cohort
Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
Time Frame: 6 years
Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma & other malignancies), pregnancies, and non-serious malignancies in participants less than (<) 30 years of age will be reported.
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Disease Status as Assessed by Partial Mayo Score
Time Frame: 6 years
The partial Mayo score, a validated tool used to assess disease status in participants with ulcerative colitis, will be utilized to assess clinical status in this registry. Information will be obtained using 3 of the individual components of the full Mayo score, including stool frequency, rectal bleeding, and PGA (Physician's Global Assessment). Each component score ranges from 0 (normal) to 3 (severe disease) and the score is the sum of those three categories. The total Partial Mayo Score will be calculated as the sum of the scores of all 3 components for each participant that ranges from 0-9.
6 years
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time Frame: 6 years
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The total score ranges from 10 (worst health) to 70 (best health).
6 years
EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score
Time Frame: 6 years
The EQ-5D-5L is a standardized non-disease specific instrument for describing and assessing health-related quality of life.This instrument evaluates 5 areas including mobility, ability for self-care, ability in usual activities, pain/discomfort and anxiety/depression.There also is a self-evaluated 100-point health assessment.
6 years
Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)
Time Frame: 6 years
The WPAI-UC is a validated instrument that measures the effect of ulcerative colitis (UC) symptoms on a patient's life (eg, diarrhea, loss of appetite, weight loss, abdominal pain, fever, joint pain, skin sores, rectal bleeding) and on his or her ability to work and perform regular activities.
6 years
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Time Frame: 6 years
The TSQM is a 14-question instrument that gauges a patient's experience with his or her medication.The questionnaire was designed to evaluate the effectiveness, side effects, and convenience of the medication over a period of 2- to 3-weeks or since the last time it was taken.
6 years
Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort
Time Frame: 6 years
Number of hospitalizations in participants in each cohort will be reported.
6 years
Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort
Time Frame: 6 years
Reasons for hospitalization in participants in each cohort will be reported.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Biotech, Inc.

Investigators

  • Study Director: Janssen Biotech, Inc. Clinical Trial, Janssen Biotech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2016

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

March 11, 2027

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimated)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR105891
  • CNTO148UCO4001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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