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Humira under the microscope: new registry tracks safety in chinese Crohn's patients

NCT ID NCT05394805

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 registry study followed 156 Chinese patients with moderate to severe Crohn's disease who were prescribed Humira (adalimumab) by their doctors. The goal was to see how safe and effective the drug is in real-world use over one year. Researchers tracked serious side effects and changes in disease activity. Since Humira is already approved for Crohn's, this study aims to confirm its benefits and risks in a Chinese population.

What this could mean

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

Active substance
Humira (adalimumab)
What this could lead to
If successful, this registry could confirm that Humira is safe and effective for treating Crohn's disease in Chinese patients, supporting its continued use.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. It only follows patients for one year, so long-term effects are not assessed.

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

156 people

The number who actually took part.

Started

Jun 2022

Finished

Dec 2024

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

Chinese adult participants with moderately to severely active crohn's disease (CD).

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: * Participants meet the diagnosis of moderate to severe Crohn's disease. * Participants prescribed with Humira, under investigators' sufficient consideration of benefits/ risks per local label. Exclusion Criteria: * Participants who have any of the contraindications as per adalimumab (Humira) label in China. * Participants who are allergic to any component of adalimumab (Humira). * Participants with active hepatitis B diagnosed. * Participants with severe active infection, or known history of active or latent tuberculosis (TB), or latent TB infection with inadequate treatment. * Participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (NMSC) completely treated, per local label. * Participants with moderate to severe heart failure. * Participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure. * Participants who are enrolled to other interventional studies. * Participants who are prescribed with adalimumab but choose Humira bio-similar in China.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn's disease

Contacts and locations

Locations

  • Nanfang Hospital of Southern Medical University /ID# 243386

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drum Tower Hospital /ID# 243385

    Nanjing, Jiangsu, 210008, China

  • Peking University Third Hospital /ID# 242803

    Beijing, Beijing Municipality, 100191, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213

    Shanghai, Shanghai Municipality, 200065, China

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801

    Hangzhou, Zhejiang, 310018, China

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798

    Guangzhou, Guangdong, 510120, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 242802

    Hangzhou, Zhejiang, 310009, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799

    Guangzhou, Guangdong, 510655, China

  • West China Hospital, Sichuan University /ID# 242804

    Chengdu, Sichuan, 610041, China

  • Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443

    Hangzhou, Zhejiang, 310006, China

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