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Scientists track drug behavior in severe colitis patients

NCT ID NCT03765450

Knowledge-focused Sponsor: Alimentiv 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the drug infliximab behaves in the body of people hospitalized with severe ulcerative colitis. Researchers measure drug levels in blood, stool, and colon tissue, along with changes in proteins and genes. The goal is to better understand how the drug works, not to test a new treatment. About 18 adults with severe colitis are taking part.

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

18 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients diagnosed with acute severe ulcerative colitis, who are biologic-naive or biologic-experienced without a known history of anti-infliximab antibodies and will be receiving infliximab infusion therapy.

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: * Present to hospital with ASUC based on Truelove and Witts criteria,33 defined as the presence of more than 6 bloody stools per day along with any 1 of the following: tachycardia \> 90 beats per minute, fever \> 37.8 °C, hemoglobin \< 10.5 g/dL, and erythrocyte sedimentation rate (ESR) \> 30 mm/h (or CRP \> 30 mg/L \[high-sensitivity CRP \> 300 mg/L\]) is a suitable surrogate if ESR is not available1). * Have a partial MCS \> 7. * Have a Mayo Clinic ES ≥ 2 with disease extending 15 cm or more beyond the anal verge. * Require rescue inpatient IFX infusion as part of routine care. Note, the IFX treatment regimen is not defined by this protocol and any dosage regimen is acceptable for the purposes of this study, such as standard or accelerated induction regimens. * Be able to speak English and participate fully in all aspects of this clinical trial. * Provide written informed consent. Exclusion Criteria: * A known history of being positive for anti-IFX antibodies. * Have a serious active infection, active malignancy, or any other known condition contraindicated with infliximab therapy, according to current prescribing information. * Serious underlying disease other than ASUC, or other physical or psychosocial condition that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study. * Prior enrollment in the current study.

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Conditions

The condition(s) this trial relates to.

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

  • Cornell University

    New York, New York, 10065, United States

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • UCSD

    San Diego, California, 92037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.