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)
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|ClinicalTrials.gov Identifier: NCT05394805|
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : March 1, 2023
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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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||252 participants|
|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|
|Actual Study Start Date :||June 29, 2022|
|Estimated Primary Completion Date :||July 21, 2024|
|Estimated Study Completion Date :||July 21, 2024|
Participants treated with Humira (Adalimumab)
Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice.
- 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.
- 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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05394805
|Contact: Yayi Sunemail@example.com|
|Peking University Third Hospital /ID# 242803||Recruiting|
|Beijing, Beijing, China, 100191|
|Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Nanfang Hospital of Southern Medical University /ID# 243386||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|The Sixth Affiliated Hosp Sun /ID# 242799||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Nanjing Drum Tower Hospital /ID# 243385||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213||Recruiting|
|Shanghai, Shanghai, China, 200065|
|West China Hospital, Sichuan University /ID# 242804||Recruiting|
|Chengdu, Sichuan, China, 610041|
|The second Affiliated hospital of Zhejiang University school of Medicine /ID# 242802||Recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801||Recruiting|
|Hangzhou, Zhejiang, China, 310018|
|Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443||Recruiting|
|Hangzhou, China, 310003|
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
|First Posted:||May 27, 2022 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|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|
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