Evaluating new biologics for treating Crohn's disease
Therapeutic Effect of New Biologics in Crohn's Disease
Sixth Affiliated Hospital, Sun Yat-sen University · NCT04923100
This study is testing how well new medications called Ustekinumab and Vedolizumab work for people with Crohn's disease and what side effects they might cause.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 17 Years to 80 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (other) |
| Drugs / interventions | Ustekinumab, Vedolizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04923100 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the short-term and long-term therapeutic effects of new biologics, specifically Ustekinumab and Vedolizumab, in patients with Crohn's disease. It will also evaluate the adverse effects associated with these treatments and identify independent factors that predict their effectiveness. The study will analyze the relationship between drug exposure, including trough and antibody concentrations, and therapeutic efficacy through a retrospective approach. Clinical data from patients receiving these biologics in China will be collected and analyzed to fill the existing knowledge gap.
Who should consider this trial
Good fit: Ideal candidates are adult patients with a confirmed diagnosis of Crohn's disease who have been treated with new biologics.
Not a fit: Patients who have incomplete clinical data, lost to follow-up, or do not have a confirmed diagnosis of Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of new biologics for Crohn's disease, potentially improving treatment strategies.
How similar studies have performed: While this study focuses on a specific population in China, similar studies evaluating the efficacy of biologics in Crohn's disease have shown promising results in other regions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics. Exclusion Criteria: * loss of follow-up, incomplete clinical data, without confirmed diagnosis
Where this trial is running
Guangzhou, Guangdong
- the Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Jiayin Yao
- Email: yjyin3@mail.sysu.edu.cn
- Phone: 13826462890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Treatment Side Effects