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Simponi under the microscope: new registry tracks Long-Term risks in ulcerative colitis patients

NCT ID NCT02808780

Knowledge-focused Sponsor: Janssen Biotech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This registry follows 535 adults with moderate-to-severe ulcerative colitis who are taking or starting Simponi. Researchers will track serious side effects like infections, cancers, and pregnancy outcomes over time. The goal is to better understand the long-term safety of this medication in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Simponi (golimumab)
What this could lead to
If successful, this registry will provide a clearer picture of Simponi's long-term safety, helping doctors and patients make more informed treatment decisions.
What could go wrong
This is an observational registry, not a treatment trial, so it won't test new therapies. Results may not apply to all patients, and rare side effects might still be missed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

535 people

The number who actually took part.

Started

Dec 2016

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lymphoma neoplasm ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Study site

    Murrieta, California, United States

  • Study site

    Rialto, California, United States

  • Study site

    Ventura, California, United States

  • Study site

    Coral Gables, Florida, United States

  • Study site

    Fort Myers, Florida, United States

  • Study site

    Lake Worth, Florida, United States

  • Study site

    Lauderdale Lakes, Florida, United States

  • Study site

    Miami, Florida, United States

  • Study site

    Tampa, Florida, United States

  • Study site

    Suwanee, Georgia, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Sylvania, Ohio, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Houston, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Lansdowne Town Center, Virginia, United States

  • Study site

    Salzburg, Austria

  • Study site

    Sankt Poelten Noe, Austria

  • Study site

    Vienna, Austria

  • Study site

    New Westminster, British Columbia, Canada

  • Study site

    Vancouver, British Columbia, Canada

  • Study site

    Oshawa, Ontario, Canada

  • Study site

    Ottawa, Ontario, Canada

  • Study site

    Pilsen, Czechia

  • Study site

    Clermont-Ferrand, France

  • Study site

    Clichy, France

  • Study site

    Créteil, France

  • Study site

    Grenoble, France

  • Study site

    Montpellier, France

  • Study site

    Nice, France

  • Study site

    Pierre-Bénite, France

  • Study site

    Saint-Priest-en-Jarez, France

  • Study site

    Strasbourg, France

  • Study site

    Berlin, Germany

  • Study site

    Dessau Roblau, Germany

  • Study site

    Halle, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    Kiel, Germany

  • Study site

    Leipzig, Germany

  • Study site

    Ludwigshafen, Germany

  • Study site

    Lyneburg, Germany

  • Study site

    München, Germany

  • Study site

    Saarbrücken, Germany

  • Study site

    Athens, Greece

  • Study site

    Heraklion, Greece

  • Study site

    Ioannina, Greece

  • Study site

    Thessaloniki, Greece

  • Study site

    Busan, South Korea

  • Study site

    Gyeonggi-do, South Korea

  • Study site

    Seongnam-si, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    A Coruña, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Córdoba, Spain

  • Study site

    Fuenlabrada, Spain

  • Study site

    Huelva, Spain

  • Study site

    Madrid, Spain

  • Study site

    Majadahonda, Spain

  • Study site

    San Sebastián de los Reyes, Spain

  • Study site

    Valencia, Spain

  • Study site

    Vigo, Spain

  • Study site

    Zaragoza, Spain

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