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)

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05394805
• Other study ID #: P20-043
• Status: Active, not recruiting
• Start date: June 29, 2022
• Est. completion date: July 21, 2024

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: July 21, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
China	Peking University Third Hospital /ID# 242803	Beijing	Beijing
China	West China Hospital, Sichuan University /ID# 242804	Chengdu	Sichuan
China	Nanfang Hospital of Southern Medical University /ID# 243386	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 242799	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 242802	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443	Hangzhou	Zhejiang
China	Nanjing Drum Tower Hospital /ID# 243385	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious Adverse Events (SAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Upto week 52
Secondary	Number of Participants With Serious Adverse Drug Reaction (ADR)	Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.	Upto week 52
Secondary	Number of Participants With Non-Serious Adverse Drug Reaction (ADR)	Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.	Upto week 52
Secondary	Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)	The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease.	Upto week 52
Secondary	Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)	The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. A reduction of 3 points and above is considered as relevant to define clinical response harvey-bradshaw index (HBI).	Upto week 52

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