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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)

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ClinicalTrials.gov Identifier: NCT05394805
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease
Crohn's Disease

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Study Type : Observational
Estimated Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : July 21, 2024
Estimated Study Completion Date : July 21, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Group/Cohort
Participants treated with Humira (Adalimumab)
Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice.



Primary Outcome Measures :
  1. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Upto week 52 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Serious Adverse Drug Reaction (ADR) [ Time Frame: Upto week 52 ]
    Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.

  2. Number of Participants With Non-Serious Adverse Drug Reaction (ADR) [ Time Frame: Upto week 52 ]
    Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.

  3. Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI) [ Time Frame: Upto week 52 ]
    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.

  4. Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI) [ Time Frame: Upto week 52 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese adult participants with moderately to severely active crohn's disease (CD).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05394805


Contacts
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Contact: Yayi Sun 844-663-3742 yayi.sun@abbvie.com

Locations
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China, Beijing
Peking University Third Hospital /ID# 242803 Recruiting
Beijing, Beijing, China, 100191
China, Guangdong
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798 Recruiting
Guangzhou, Guangdong, China, 510120
Nanfang Hospital of Southern Medical University /ID# 243386 Recruiting
Guangzhou, Guangdong, China, 510515
The Sixth Affiliated Hosp Sun /ID# 242799 Recruiting
Guangzhou, Guangdong, China, 510655
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213 Recruiting
Shanghai, Shanghai, China, 200065
China, Sichuan
West China Hospital, Sichuan University /ID# 242804 Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 242802 Recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801 Recruiting
Hangzhou, Zhejiang, China, 310018
China
Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443 Recruiting
Hangzhou, China, 310003
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05394805    
Other Study ID Numbers: P20-043
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Crohn's Disease
HUMIRA®
Adalimumab
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases