MedTrace Logo

Clinical Outcome After Escalation and De-escalation of Adalimumab in Real Life in Ulcerative Colitis

NCT03142113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2017-10-26

No results posted yet for this study

Summary

This retrospective multi-centric Belgian observational trial will involve all patients who have initiated adalimumab for moderate-to-severe ulcerative colitis prior to September 1st 2015 in a Belgian centre maintaining a prospective log of patients using biological therapy.

Only patients fulfilling all Belgian reimbursement criteria for adalimumab will be included, namely having failed mesalamine and steroids or thiopurine analogues for at least 3 months, or being intolerant to this therapy, and showing a total Mayo score of at least 6 with an endoscopic sub-score of at least 2.

Both short-term and long-term outcome of adalimumab therapy will be evaluated, focusing on the need and successfulness of adalimumab dose-escalation from 40mg every other week to 40mg every week, and dose de-escalation back to 40mg every other week.

Conditions

Sponsors & Collaborators

  • Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    collaborator OTHER

  • Imelda Hospital, Bonheiden

    collaborator OTHER

  • University of Liege

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • AZ Delta

    collaborator OTHER

  • Algemeen Ziekenhuis Maria Middelares

    collaborator OTHER

  • University Hospital, Ghent

    collaborator OTHER

  • General Hospital Groeninge

    collaborator OTHER

  • Centre Hospitalier Universitaire UCLouvain Namur

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • Onze Lieve Vrouwziekenhuis Aalst

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marc Ferrante, MD PhD · Universitaire Ziekenhuizen KU Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142113 on ClinicalTrials.gov