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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with Humira (Adalimumab) | Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upto week 52 |
| Number of Participants With Non-Serious Adverse Drug Reaction (ADR) |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese adult participants with moderately to severely active crohn's disease (CD).
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital /ID# 242803 | Beijing | Beijing Municipality | 100191 | China | ||
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 242798 |
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Adverse drug reactions were defined as adverese events (AEs) of which a causal relationship with adalimumab could not be ruled out. |
| 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. | 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). | Upto week 52 |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Nanfang Hospital of Southern Medical University /ID# 243386 | Guangzhou | Guangdong | 510515 | China |
| The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 242799 | Guangzhou | Guangdong | 510655 | China |
| Nanjing Drum Tower Hospital /ID# 243385 | Nanjing | Jiangsu | 210008 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 243213 | Shanghai | Shanghai Municipality | 200065 | China |
| West China Hospital, Sichuan University /ID# 242804 | Chengdu | Sichuan | 610041 | China |
| Zhejiang Provincial Hospital of Chinese Medicine /ID# 243443 | Hangzhou | Zhejiang | 310006 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 242802 | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 242801 | Hangzhou | Zhejiang | 310018 | China |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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