Assessing the effectiveness of adding GMA to Infliximab for children with ulcerative colitis
Clinical Trial to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
This study is testing whether adding a new treatment called GMA to Infliximab can help children with ulcerative colitis who haven't responded to steroids feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Adacyte Therapeutics SL Industry-sponsored |
| Locations | 10 sites (Coimbra and 9 other locations) |
| Trial ID | NCT05430412 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of adding GMA to Infliximab (IFX) treatment in pediatric patients suffering from steroid-refractory ulcerative colitis. The primary endpoint focuses on clinical response measured by the Pediatric Ulcerative Colitis Activity Index (PUCAI) score, IFX serum levels, and the need for steroid treatment. Secondary objectives include monitoring various biomarkers and clinical outcomes over a 40-week period to assess the overall effectiveness of the intervention. The study aims to provide a comprehensive analysis of treatment responses and potential improvements in patient management.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 18 years old with steroid-refractory ulcerative colitis who have previously started IFX treatment.
Not a fit: Patients who have received other anti-TNF therapies prior to the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for children with ulcerative colitis who do not respond to steroids.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving treatment outcomes for ulcerative colitis patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients under 18 years of age and weighing ≥25 kg at the time of study initiation. 2. Patients with diagnosis of UC. 3. Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC). 4. Patients who have received IFX between 12 and 16 weeks prior to the study initiation. 5. Patients who have showed a clinical response to IFX at the time of study initiation (defined as a reduction of at least 15 points in PUCAI score and being maintained below 30 points). 6. Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation. 7. Patient´s legal guardian must be willing and able to give written informed consent, and the patient must be willing to give written informed assent (if applicable as determined by the Ethics Committee) and comply with the Study visit Schedule. Exclusion Criteria: 1. Patients who have received another anti-TNF prior to entry in the study. 2. Patients with a peripheral circulation count of less than 2,000 granulocytes per μL. 3. Pregnant and lactating of childbearing potential patients. 4. Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.
Where this trial is running
Coimbra and 9 other locations
- Hospital Coimbra — Coimbra, Portugal (Recruiting)
- Hospital Santa Maria — Lisboa, Portugal (Recruiting)
- Hospital Soa Joao — Oporto, Portugal (Recruiting)
- Hospital H. Sant Joan de Déu — Sant Joan Despí, Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Infantil Universitario Niño Jesús — Madrid, Spain (Recruiting)
- Hospital Materno-Infantil del H.U.R. de Málaga — Málaga, Spain (Recruiting)
- Complejo H. Regional Virgen Del Rocío — Sevilla, Spain (Recruiting)
- Hospital U. Ntra Señora de Candelaria — Tenerife, Spain (Recruiting)
- Hospital Universitari I Politècnic La Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Pablo Zapico
- Email: p.zapico@adacyte.com
- Phone: 34 687 975 712
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.