An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
OPAL
Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
2 other identifiers
observational
537
9 countries
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
December 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 11, 2027
May 8, 2026
May 1, 2026
10 years
May 30, 2016
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
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 Outcomes (7)
Clinical Disease Status as Assessed by Partial Mayo Score
6 years
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
6 years
EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score
6 years
Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)
6 years
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
6 years
- +2 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed
You may qualify if:
- 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:
- The participant is currently receiving Simponi ,or
- The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
- The participant is scheduled to receive Simponi within 30 days after enrollment
- For Thiopurine cohort:
- The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
- Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
- Participant may have received biologics other than Simponi or investigational agents prior to enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Unknown Facility
Murrieta, California, United States
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Rialto, California, United States
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Ventura, California, United States
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Coral Gables, Florida, United States
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Fort Myers, Florida, United States
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Lake Worth, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Suwanee, Georgia, United States
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Chicago, Illinois, United States
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Sylvania, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Lansdowne Town Center, Virginia, United States
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Salzburg, Austria
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Sankt Poelten Noe, Austria
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Vienna, Austria
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New Westminster, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Pilsen, Czechia
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Clermont-Ferrand, France
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Clichy, France
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Créteil, France
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Grenoble, France
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Montpellier, France
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Nice, France
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Pierre-Bénite, France
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Saint-Priest-en-Jarez, France
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Strasbourg, France
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Berlin, Germany
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Dessau Roblau, Germany
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Halle, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Lyneburg, Germany
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München, Germany
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Saarbrücken, Germany
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Athens, Greece
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Heraklion, Greece
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Ioannina, Greece
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Thessaloniki, Greece
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Busan, South Korea
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Gyeonggi-do, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Córdoba, Spain
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Fuenlabrada, Spain
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Huelva, Spain
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Madrid, Spain
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Majadahonda, Spain
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San Sebastián de los Reyes, Spain
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Valencia, Spain
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Vigo, Spain
Unknown Facility
Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Biotech, Inc. Clinical Trial
Janssen Biotech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 22, 2016
Study Start
December 16, 2016
Primary Completion (Estimated)
December 10, 2026
Study Completion (Estimated)
March 11, 2027
Last Updated
May 8, 2026
Record last verified: 2026-05