Follow-up on granulocyte apheresis treatment for inflammatory bowel disease

National Post-market Clinical Follow-up Study to Evaluate in Real-world Practice the Efficacy and Safety of Granulocytoapheresis and Its Impact on Quality of Life in Patients With Inflammatory Bowel Disease

This study is testing whether a treatment called granulocyte apheresis can help adults with ulcerative colitis or Crohn's disease feel better over a year.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adacyte Therapeutics SL (Industry-sponsored)
• Locations: 30 sites (Albacete, Albacete and 29 other locations)
• Trial ID: NCT05636709 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy of granulocyte apheresis (GMA) using the Adacolumn® device in adult patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). It will enroll approximately 350 patients from around 30 centers in Spain, following them for 12 months after GMA therapy. The study will assess the treatment's effectiveness in real-world conditions, with patients receiving GMA sessions as per standard protocols. Follow-up visits will occur at 1, 6, and 12 months post-treatment to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of ulcerative colitis or Crohn's disease who are starting GMA treatment.

Not a fit: Patients with medical or psychological disorders that may interfere with study compliance or those currently participating in another clinical trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective alternative treatment for patients suffering from ulcerative colitis and Crohn's disease.

How similar studies have performed: Previous studies have indicated that granulocyte apheresis can be an effective treatment for inflammatory bowel disease, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years.
2. Established diagnosis of UC or CD according to ECCO criteria.
3. Patients in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study.
4. Patients who understand and voluntarily sign informed consent.

Exclusion Criteria:

1. Patient with any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
2. Patient who is participating in a clinical trial.

NOTE: If the physician knows or suspects that the patient is unable to understand the implications of his/her participation in the study, the patient should not enter without the signature of his/her legal representative

Where this trial is running

Albacete, Albacete and 29 other locations

• H. Albacete — Albacete, Albacete, Spain (Recruiting)
• H. General de Alicante — Alicante, Alicante, Spain (Recruiting)
• H. Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
• H. Vall d´hebron — Barcelona, Barcelona, Spain (Recruiting)
• H. Galdakao — Galdakao, Bizkaia, Spain (Recruiting)
• H. General de Castellón — Castellon, Castellón, Spain (Recruiting)
• H. Puerta del Mar — Cadiz, Cádiz, Spain (Recruiting)
• H. Reina Sofía — Córdoba, Córdoba, Spain (Recruiting)
• H. Donostia — San Sebastián, Gipuzkoa, Spain (Recruiting)
• H. Virgen de las Nieves — Granada, Granada, Spain (Recruiting)
• H. Guadalajara — Guadalajara, Guadalajara, Spain (Recruiting)
• H. San Jorge — Huesca, Huesca, Spain (Recruiting)
• H. Santiago — Santiago de Compostela, La Coruña, Spain (Recruiting)
• H. San Pedro — Logroño, La Rioja, Spain (Recruiting)
• H. Dr. Negrín — Las Palmas de Gran Canaria, Las Palmas de Gran Canarias, Spain (Recruiting)
• H. 12 de octubre — Madrid, Madrid, Spain (Recruiting)
• H. La Paz — Madrid, Madrid, Spain (Recruiting)
• H. Costa del Sol — Marbella, Málaga, Spain (Recruiting)
• H. Navarra — Pamplona, Navarre, Spain (Recruiting)
• H. Río Carrión — Palencia, Palencia, Spain (Recruiting)
• H. Son Espases — Palma de Mallorca, Palma de Mallorca, Spain (Recruiting)
• H. Son Llatzer — Palma de Mallorca, Palma de Mallorca, Spain (Recruiting)
• H. Álvaro Cunqueiro — Vigo, Pontevedra, Spain (Recruiting)
• H. Univ. de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain (Recruiting)
• H. Ntra. Sra. de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
• H. Virgen del Rocío — Seville, Sevilla, Spain (Recruiting)
• H. Clínico Univ. de Valencia — Valencia, Valencia, Spain (Recruiting)
• H. General de Valencia — Valencia, Valencia, Spain (Recruiting)
• H. La Fe — Valencia, Valencia, Spain (Recruiting)
• H. Virgen de la Concha — Zamora, Zamora, Spain (Recruiting)

Study contacts

• Study coordinator: Mercedes Benavente

Conditions Crohn Disease; Ulcerative Colitis