Efficacy and Safety of Low-Dose Upadacitinib Combined With Ustekinumab in the Treatment of Refractory Crohn's Disease

Sponsor
Shanghai 10th People's Hospital
Study ID
NCT07697547
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Upadacitinib was administered orally at a low dose of 15 mg/day or 30 mg/day for at least 12 weeks in combination with ustekinumab.
  • Ustekinumab (UST) — DRUG
    Ustekinumab was administered as intravenous induction based on body weight, followed by subcutaneous maintenance therapy at 90 mg every 8 weeks, in combination with low-dose upadacitinib.

Study Details

A multicenter retrospective study evaluating the effectiveness and safety of ustekinumab combined with low-dose upadacitinib in patients with refractory Crohn's disease.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 1, 2023
Status verified
Jul 2026
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
84 participants (actual)

Arms

  • Arm: Low-dose upadacitinib plus ustekinumab cohort
    Patients with refractory Crohn's disease who received low-dose upadacitinib in combination with ustekinumab in a multicenter retrospective real-world cohort study.

Primary Outcome Measure

Clinical remission rate at Week 12 to Week 16 [ Time Frame: Week 12 to Week 16 after initiation of combination therapy ]

Find similar trials

Nationwide
Crohn's disease trialsGastroenterology trialsInflammatory bowel disease trialsAutoimmune disease trials

Related Studies