Upadacitinib versus corticosteroids for first-line treatment of acute severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, head-to-head Phase 4 comparison of upadacitinib extended-release tablets versus standard corticosteroid therapy as first-line treatment for acute severe ulcerative colitis. Participants are assigned to receive upadacitinib 45 mg once daily for 8 weeks then 30 mg daily, or intravenous methylprednisolone 60 mg/day with planned switch to oral prednisone when clinically appropriate. The trial measures clinical remission rates and tracks adverse events to compare safety profiles. Outcomes will inform whether upadacitinib can be used safely and effectively instead of corticosteroids in this acute setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with ASUC
* Aged 18 years or older.
* No gender restriction.

Exclusion Criteria:

* Presence of contraindications, allergy, or intolerance to upadacitinib or glucocorticoids.
* Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
* Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
* Pregnant or breastfeeding women.
* Unwilling to participate in the clinical study.

Where it's running

• Ankang Central Hospital
  Ankang, Shaanxi, China Recruiting
• 3201 Hospital
  Hanzhong, Shaanxi, China Recruiting
• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting
• Shaanxi Provincial Nuclear Industry 215 Hospital
  Xianyang, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Yongquan Shi
• Email: von15991351319@163.com
• Phone: +8602984771535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.