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Recruiting NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

— Observational Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upadacitinib.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study

Overview

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.

Interventions

  • Drug Upadacitinib
    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.

Primary outcome measures

  • Clinical Remission Rate [Time frame: 52 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 6 centers
  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou
  • Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • Meizhou People's Hospital — Meizhou
  • The Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen
  • Liuzhou People's Hospital — Liuzhou
  • Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine — Nanning

Publications

  • Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728. PMID 37224198
  • Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, PMID 35644166

Identifiers

NCT: NCT06780683 · 2024ZSLYEC-250

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗