An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
NCT ID: NCT02808780
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
537 participants
OBSERVATIONAL
2016-12-16
2027-03-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Biotech, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Biotech, Inc.
Locations
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Murrieta, California, United States
Rialto, California, United States
Ventura, California, United States
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
Suwanee, Georgia, United States
Chicago, Illinois, United States
Sylvania, Ohio, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Lansdowne Town Center, Virginia, United States
Salzburg, , Austria
Sankt Poelten Noe, , Austria
Vienna, , Austria
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Pilsen, , Czechia
Clermont-Ferrand, , France
Clichy, , France
Créteil, , France
Grenoble, , France
Montpellier, , France
Nice, , France
Pierre-Bénite, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Berlin, , Germany
Dessau Roblau, , Germany
Halle, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Kiel, , Germany
Leipzig, , Germany
Ludwigshafen, , Germany
Lyneburg, , Germany
München, , Germany
Saarbrücken, , Germany
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Busan, , South Korea
Gyeonggi-do, , South Korea
Seongnam-si, , South Korea
Seoul, , South Korea
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
Countries
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Other Identifiers
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CNTO148UCO4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR105891
Identifier Type: -
Identifier Source: org_study_id