NCT05394805Completed
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
A One-year Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Crohn's Disease (CD) in China
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective Humira (adalimumab) is in treating moderately to severely active CD in China. Adverse events and change in disease activity will be assessed. Humira (adalimumab) is a drug approved for the treatment of Crohn's disease (CD).All study participants will receive Humira as prescribed by their study doctor in accordance with approved local label. Approximately 252 participants will be enrolled in China. Participants will receive subcutaneous HUMIRA (adalimumab) injection as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 1 year. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 156 (actual)
- First submitted
- 25 May 2022
- Start date
- 29 Jun 2022
- Primary completion date
- 26 Dec 2024
- Lead sponsor
- AbbVie
- Diseases
- Crohn's disease
- NCT number
- NCT05394805
What you commit to
- Study type: Observational
- Participants enrolled: 156
- From 29 Jun 2022 to the primary completion date, 26 Dec 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Participants who have any of the contraindications as per adalimumab (Humira) label in China.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital /ID# 242803 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital, Sichuan University /ID# 242804 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University /ID# 243386 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 242802 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Nanjing Drum Tower Hospital /ID# 243385 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.