Golimumab Trough Levels in Patients With Ulcerative Colitis

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 therapeutic drug monitoring. Moreover, many exposure-response relationship studies have shown that higher serum anti-TNF drug concentrations are associated with better clinical outcomes in IBD, suggesting that it is maybe time to go from a 'treat-to-target' to a 'treat-to trough' therapeutic approach. In this scenario, there are very limited data regarding therapeutic drug monitoring with golimumab in UC and even no data regarding a therapeutic window to target for important objectives outcomes like mucosal healing and histological remission.

Conditions

• Ulcerative Colitis

Interventions

DIAGNOSTIC_TEST

Golimumab trough levels

Golimumab trough levels taken immediately before the administration of the next subcutaneous dose of golimumab

DIAGNOSTIC_TEST

Antibodies to golimumab

Antibodies to golimumab taken immediately before the administration of the next subcutaneous dose of golimumab

DIAGNOSTIC_TEST

Histology

Histology of colonic biopsies using the Geboes Index

DIAGNOSTIC_TEST

Colonoscopy

Colonoscopy to evaluate the endoscopic activity by a Mayo endoscopic subscore

Sponsors & Collaborators

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Gregorio Marañón Hospital

  collaborator OTHER

• Complejo Hospitalario de Navarra

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital Infanta Sofia

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Puerta de Hierro University Hospital

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario de Fuenlabrada

  collaborator OTHER

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Hospital San Carlos, Madrid

  lead OTHER

Principal Investigators

• Carlos Taxonera, Dr. · Hospital San Carlos, Madrid

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• Spain

Study Locations