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Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.
Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks.
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 |
|---|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who reported Serious Adverse Event | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. 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. | Up to 52 weeks |
| Percentage of participants who reported Serious Adverse Drug Reaction | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. | Up to 52 weeks |
| Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. | Up to 52 weeks |
| Percentage of participants who reported known (labeled) Adverse Drug Reaction | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. | Up to 52 weeks |
| Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with ulcerative colitis or Crohn's Disease
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SoonChunHyang University Hospital Cheonan /ID# 270015 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea | ||
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An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. |
| Up to 52 weeks |
| Percentage of participants who reported the events related to important identified risks/important potential risks/missing information | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. | Up to 52 weeks |
| The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843 |
| Daejeon |
| Daejeon Gwang Yeogsi |
| 34943 |
| South Korea |
| Inje University - Ilsan Paik Hospital /ID# 269995 | Goyang-si | Gyeonggido | 10380 | South Korea |
| Keimyung University Dongsan Hospital /ID# 269775 | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Chosun University Hospital /ID# 269990 | Gwangju | Jeonranamdo | 61453 | South Korea |
| Kyung Hee University Hospital /ID# 270003 | Dongdaemun-gu | Seoul Teugbyeolsi | 02447 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 268865 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Gangnam Severance Hospital /ID# 270020 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 270013 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Ewha Womans University Medical Centre /ID# 269776 | Seoul | Seoul Teugbyeolsi | 07985 | South Korea |
| Ulsan University Hospital /ID# 270006 | Ulsan | Ulsan Gwang Yeogsi | 44033 | South Korea |
| Yeungnam University Medical Center /ID# 269992 | Daegu | 42415 | South Korea |
| Seoul Songdo Hospital /ID# 270009 | Junggu | 04597 | South Korea |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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