Status:
COMPLETED
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)
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 severel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 26 2024
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05394805
Start Date
June 29 2022
End Date
December 26 2024
Last Update
November 17 2025
Active Locations (10)
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1
Peking University Third Hospital /ID# 242803
Beijing, Beijing Municipality, China, 100191
2
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798
Guangzhou, Guangdong, China, 510120
3
Nanfang Hospital of Southern Medical University /ID# 243386
Guangzhou, Guangdong, China, 510515
4
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799
Guangzhou, Guangdong, China, 510655