Crohn's DiseaseNCT05394805
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)
An observational study of Crohn's Disease, run by AbbVie at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 156 participants
- Where
- 10 sitesChina
- Study dates
- 29 Jun 2022to 26 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adult participants with moderately to severely active crohn's disease (CD).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Peking University Third Hospital /ID# 242803
Beijing, Beijing Municipality, 100191
West China Hospital, Sichuan University /ID# 242804
Chengdu, Sichuan, 610041
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798
Guangzhou, Guangdong, 510120
Nanfang Hospital of Southern Medical University /ID# 243386
Guangzhou, Guangdong, 510515
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799
Guangzhou, Guangdong, 510655
Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443
Hangzhou, Zhejiang, 310006
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 242802
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801
Hangzhou, Zhejiang, 310018
Nanjing Drum Tower Hospital /ID# 243385
Nanjing, Jiangsu, 210008
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213
Shanghai, Shanghai Municipality, 200065
About this study
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
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.
Read more
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
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with Humira (Adalimumab) | Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upto week 52
Secondary outcomes (4)
Number of Participants With Serious Adverse Drug Reaction (ADR)
Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.
Measured: Upto week 52
Number of Participants With Non-Serious Adverse Drug Reaction (ADR)
Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out.
Measured: Upto week 52
Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)
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.
Measured: Upto week 52
Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)
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).
Measured: Upto week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start29 Jun 2022
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394805
- Sponsor's protocol ID
- P20-043
- Status last verified
- Nov 2025
- First submitted
- 25 May 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05394805
- Acronym / sponsor ID
- P20-043
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, HUMIRA®, Adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Humira (Adalimumab) | – | –Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult participants with moderately to severely active crohn's disease (CD).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Number of Participants With Serious Adverse Drug Reaction (ADR)
Time frame: Upto week 52
Number of Participants With Non-Serious Adverse Drug Reaction (ADR)
Time frame: Upto week 52
Number of Participants who Achieved Clinical Remission Harvey-Bradshaw index (HBI)
Time frame: Upto week 52
Number of Participants who Achieved Clinical Response Harvey-Bradshaw index (HBI)
Time frame: Upto week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by AbbVie at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious Adverse Events (SAEs) (time frame: Upto week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.