Status:
COMPLETED
Golimumab Trough Levels in Patients With Ulcerative Colitis
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Hospital Universitario La Fe
Hospital Universitario 12 de Octubre
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
Proactive therapeutic drug monitoring of Anti-TNFs with drug titration to a therapeutic window is associated with favorable long-term therapeutic outcomes in IBD and may be superior to reactive therap...
Detailed Description
Tumor necrosis factor (TNF)-α antagonists have changed the goals of ulcerative colitis (UC) treatment, with the focus now on preventing disease progression rather than just controlling symptoms. Anti-...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years.
- Patients with a diagnosis of ulcerative colitis at least 12 months prior to the start of the study.
- Patients previously treated with golimumab for ulcerative colitis prescribed according to the usual clinical practice of each center and who have received at least 5 maintenance doses according to the guidelines accepted in the technical file.
- Sign of informed consent.
Exclusion
- Patients with Crohn's disease or colitis pending classification
- Alterations in the coagulation that contraindicate the taking of biopsies
- Patients with moderate-severe heart failure (grades III / IV NYHA)
- Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections
- Psychiatric illness that discourages participation in the study
- Patients with a history of hypersensitivity to golimumab, to other murine proteins or to any of the excipients included in the golimumab data sheet
- Withdrawal of the informed consent by the patient
- Any other condition that in the opinion of the investigator discourages the participation of the subject in the study.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03773445
Start Date
March 1 2019
End Date
September 30 2021
Last Update
April 15 2022
Active Locations (12)
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1
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
2
Hospital Universitario Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
3
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
4
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain, 28703