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)

Last updated: November 14, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT05394805
P20-043
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participants meet the diagnosis of moderate to severe Crohn's disease.

  • Participants prescribed with Humira, under investigators' sufficient considerationof benefits/ risks per local label.

Exclusion

Exclusion Criteria:

  • Participants who have any of the contraindications as per adalimumab (Humira) labelin 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 latenttuberculosis (TB), or latent TB infection with inadequate treatment.

  • Participants with cancer diagnosed, excluding also those with non-melanoma skincancer (NMSC) completely treated, per local label.

  • Participants with moderate to severe heart failure.

  • Participants who are unwilling to participate, or not suitable for participation asjudged 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 inChina.

Study Design

Total Participants: 156
Study Start date:
June 29, 2022
Estimated Completion Date:
December 26, 2024

Connect with a study center

  • Peking University Third Hospital /ID# 242803

    Beijing, Beijing 100191
    China

    Site Not Available

  • Peking University Third Hospital /ID# 242803

    Beijing 1816670, Beijing Municipality 2038349 100191
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University /ID# 243386

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The Sixth Affiliated Hosp Sun /ID# 242799

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University /ID# 243386

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798

    Guangzhou 1809858, Guangdong 1809935 510120
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799

    Guangzhou 1809858, Guangdong 1809935 510655
    China

    Site Not Available

  • Nanjing Drum Tower Hospital /ID# 243385

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Nanjing Drum Tower Hospital /ID# 243385

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213

    Shanghai, Shanghai 200065
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213

    Shanghai 1796236, Shanghai Municipality 1796231 200065
    China

    Site Not Available

  • West China Hospital, Sichuan University /ID# 242804

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University /ID# 242804

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801

    Hangzhou, Zhejiang 310018
    China

    Site Not Available

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 242802

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801

    Hangzhou 1808926, Zhejiang 1784764 310018
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 242802

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

  • Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443

    Hangzhou 1808926, Zhejiang 1784764 310006
    China

    Site Not Available

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