Clinical trial NCT05394805: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
HUMIRA®
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adult participants with moderately to severely active crohn's disease (CD).

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Upto week 52
Secondary outcomes:
measure: Number of Participants With Serious Adverse Drug Reaction (ADR)
timeFrame: Upto week 52
measure: Number of Participants With Non-Serious Adverse Drug Reaction (ADR)
timeFrame: Upto week 52
measure: Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)
timeFrame: Upto week 52
measure: Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)
timeFrame: Upto week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 242803
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 243386
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 243385
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 242804
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 242802
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: