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Humira shows promise for Long-Term control of Kids' colitis

NCT ID NCT02632175

Disease control Sponsor: AbbVie 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety and effectiveness of adalimumab (Humira) in 59 children with ulcerative colitis who had already completed a previous trial. The children received injections every other week or weekly. Researchers tracked side effects and how well the drug controlled disease symptoms using standard scoring tools. The goal was to see if adalimumab remains safe and effective over an extended period.

What this could mean

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

Active substance
adalimumab (Humira)
What this could lead to
If successful, this could confirm that adalimumab is a safe long-term option to control ulcerative colitis in children, reducing flare-ups and improving daily life.
What could go wrong
This is a small, open-label study (no placebo) with only 59 children, so results may not apply to all patients. Long-term use of adalimumab carries risks like serious infections and allergic reactions.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

59 people

The number who actually took part.

Started

Nov 2015

Finished

Apr 2025

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.

Ages

4 to 17 years

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: \- Subject must have successfully enrolled and completed M11-290 study Exclusion Criteria: \- Subject considered by the investigator, for any reason, to be an unsuitable candidate

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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

  • Arnold Palmer Hospital /ID# 147295

    Orlando, Florida, 32806, United States

  • Centrum Zdrowia MDM /ID# 147280

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290

    London, Greater London, E1 2ES, United Kingdom

  • Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292

    London, Greater London, NW3 2QG, United Kingdom

  • Gabinet Lekarski Bartosz Korcz /ID# 147281

    Rzeszów, Podkarpackie Voivodeship, 35-210, Poland

  • Hospital Universitario Vall d'Hebron /ID# 147288

    Barcelona, 08035, Spain

  • Instytut Centrum Zdrowia Matki Polki /ID# 169017

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Juntendo University Hospital /ID# 147315

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kurume University Hospital /ID# 145710

    Kurume-shi, Fukuoka, 830-0011, Japan

  • MNGI Digestive Health, P. A. /ID# 147294

    Minneapolis, Minnesota, 55413-2195, United States

  • Mayo Clinic - Rochester /ID# 147304

    Rochester, Minnesota, 55905-0001, United States

  • MultiCare Institute Health System /ID# 169005

    Tacoma, Washington, 98405, United States

  • National Center for Child Health and Development /ID# 147312

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Univerzitna nemocnica Martin /ID# 147283

    Martin, Žilina Region, 036 01, Slovakia

  • Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310

    Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

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