Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
Observational · No treatment assigned · 6 sites · Xiang Gao
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Crohn's Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 174 participants are expected to take part.
- Start date: 2024-01-01.
- Main results expected around 2028-12-31 (estimate from the record).
- 6 study sites listed (6 marked recruiting) in China.
Main thing being measured
- Clinical Remission Rate (52 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | Xiang Gao |
| Enrollment | 174 (estimated) |
| Start date | 2024-01-01 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2025-01-17 |
| Last updated | 2025-01-17 |
| 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 |
| ClinicalTrials.gov ID | NCT06780683 |
Interventions
- 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.
Full eligibility criteria (from the record)
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.
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou, Guangdong | China | Recruiting |
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
| Meizhou People's Hospital | Meizhou, Guangdong | China | Recruiting |
| The Eighth Affiliated Hospital, Sun Yat-Sen University | Shenzhen, Guangdong | China | Recruiting |
| Liuzhou People's Hospital | Liuzhou, Guangxi | China | Recruiting |
| Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine | Nanning, Guangxi | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.