Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease (EaseUpIBD)

Xiang Gao

Status

Enrolling

Conditions

Inflammatory Bowel Disease

Ulcerative Colitis

Crohn's Disease

Treatments

Drug: Upadacitinib

Study type

Observational

Funder types

Other

Identifiers

NCT06780683

2024ZSLYEC-250

Details and patient eligibility

About

Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.

Enrollment

174 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.

Exclusion criteria

Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.