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)

Study Identifier
P20-043
CT.gov Identifier
NCT05394805
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Peking University Third Hospital /ID# 242803
    Beijing, Beijing Municipality, China, 100191
    Status
    Not applicable
    Location
    Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798
    Guangzhou, Guangdong, China, 510120
    Status
    Not applicable
    Location
    Nanfang Hospital of Southern Medical University /ID# 243386
    Guangzhou, Guangdong, China, 510515
    Status
    Not applicable
    Location
    The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799
    Guangzhou, Guangdong, China, 510655
    Status
    Not applicable
    Location
    Nanjing Drum Tower Hospital /ID# 243385
    Nanjing, Jiangsu, China, 210008
    Status
    Not applicable
    Location
    Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213
    Shanghai, Shanghai Municipality, China, 200065
    Status
    Not applicable
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