Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXiang Gao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population was derived from IBD centers in China.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Upadacitinib

    Drug

    Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease). Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Crohn's disease1 intervention
Group B: ulcerative colitis1 intervention

Trial outcomes

Primary outcomes

1

Clinical Remission Rate

Clinical remission rate in patients with ulcerative Colitis or Crohn's Disease.

Time frame
52 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiang Gao

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution