Upadacitinib versus infliximab for second-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 phase 4 randomized comparison assigns adults with acute severe ulcerative colitis who require second-line therapy to either oral upadacitinib (45 mg daily for 8 weeks then 30 mg daily) or intravenous infliximab (5 mg/kg at weeks 0, 2, 6 and then every 8 weeks) and follows them for three months. Patients attend outpatient visits for clinical assessments, lab tests, and safety monitoring, with outcomes including remission rates, adverse events, and need for colectomy. The protocol includes specific safety surveillance for infections and organ-specific toxicities given the immune-modulating nature of both drugs. The trial will directly compare effectiveness and tolerability of an oral JAK inhibitor versus an IV anti-TNF biologic as second-line options.

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 infliximab.
* 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 Hosipital of Digestive Disease
  Xi'an, Shaanxi, China Recruiting
• Shaanxi Provincial Nuclear Industry 215 Hospital
  Xianyang, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Yongquan Shi, Ph.D
• Email: shiyquan@fmmu.edu.cn
• Phone: 86-029-84771535

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.