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)

• ClinicalTrials.gov Identifier: NCT05394805
• Recruitment Status: Recruiting
• First Posted: May 27, 2022
• Last Update Posted: March 1, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: May 25, 2022
• First Posted Date: May 27, 2022
• Last Update Posted Date: March 1, 2023
• Actual Study Start Date: June 29, 2022
• Estimated Primary Completion Date: July 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2022)

• 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.
• 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.
• 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.
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Chinese adult participants with moderately to severely active crohn's disease (CD).
• Condition: Crohn's Disease
• Intervention: Not Provided

Study Groups/Cohorts

Participants treated with Humira (Adalimumab)

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 25, 2022): 252
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 21, 2024
• Estimated Primary Completion Date: July 21, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05394805
• Other Study ID Numbers: P20-043
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: February 2023