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)

NCT05394805 | Completed

• 1 other identifier: P20-043
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 10

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; HUMIRA®; Adalimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Serious Adverse Drug Reaction (ADR)

  Upto week 52

• Number of Participants With Non-Serious Adverse Drug Reaction (ADR)

  Upto week 52

• Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)

  Upto week 52

• Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)

  Upto week 52

Study Arms (1)

Participants treated with Humira (Adalimumab)

Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adult participants with moderately to severely active crohn's disease (CD).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Peking University Third Hospital /ID# 242803

Beijing, Beijing Municipality, 100191, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

Nanfang Hospital of Southern Medical University /ID# 243386

Guangzhou, Guangdong, 510515, China

Location

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

Guangzhou, Guangdong, 510655, China

Location

Nanjing Drum Tower Hospital /ID# 243385

Nanjing, Jiangsu, 210008, China

Location

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

Shanghai, Shanghai Municipality, 200065, China

Location

West China Hospital, Sichuan University /ID# 242804

Chengdu, Sichuan, 610041, China

Location

Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443

Hangzhou, Zhejiang, 310006, China

Location

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

Hangzhou, Zhejiang, 310009, China

Location

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

Hangzhou, Zhejiang, 310018, China

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 27, 2022
• Study Start: June 29, 2022
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (10)