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

NCT03142113 | Completed

• 1 other identifier: S59663
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Keywords

optimization; adalimumab

Outcome Measures

Primary Outcomes (1)

• The need and success of adalimumab dose escalation from 40mg every other week to 40mg every week in patients with moderate-to-severe ulcerative colitis during adalimumab treatment

  The proportion of patients requiring dose-escalation from adalimumab 40mg every other week to 40mg every week and the success rate of this intervention. Success of dose-escalation is defined based on a positive physician global assessment and absence of blood on two consecutive visits at least 3 months apart from each other. Of note: patients requiring a second intervention later on (addition of any type of steroids, addition of any immunomodulatory drug or optimization to off-label adalimumab 80 mg every week) will be regarded as failure (treatment optimization based on trough level monitoring or biomarkers alone will not be included)

  Through study completion, an average of 24 months

Secondary Outcomes (15)

• Short-term (steroid-free) clinical response response to adalimumab in patients with moderate-to-severe ulcerative colitis

  Week 8

• Short-term (steroid-free) clinical remission response to adalimumab in patients with moderate-to-severe ulcerative colitis

  Week 8

• Short-term (steroid-free) clinical benefit to adalimumab in patients with moderate-to-severe ulcerative colitis

  Week 8

• Short-term (steroid-free) mucosal healing under adalimumab in patients with moderate-to-severe ulcerative colitis

  Week 8

• Short-term (steroid-free) complete mucosal healing under adalimumab in patients with moderate-to-severe ulcerative colitis

  Week 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enrol all subjects who initiated adalimumab for moderate-to-severe ulcerative colitis before September 1st 2015 at 11 sites throughout Belgium. These 11 sites have pre-screened their database, and almost 300 patients seem eligible.

You may qualify if:

• Age at least 18 at initiation of adalimumab therapy
• Adalimumab initiated before September 1st 2015
• Established diagnosis of ulcerative colitis
• Having failed mesalamine and steroids or thiopurine analogues for at least 3 months, or being intolerant to this therapy (as described in the Belgian reimbursement criteria)
• Active ulcerative colitis as described in the Belgian reimbursement criteria, namely showing a total Mayo score of at least 6 with an endoscopic sub-score of at least 2

You may not qualify if:

• Subjects with Crohn's disease or inflammatory bowel disease (IBD) type unclassified
• Subjects previously treated with adalimumab
• Subjects treated with adalimumab for other reasons than moderate-to-severe ulcerative colitis, including extra-intestinal manifestations and pre-emptively switch from other biological therapies (i.e. while being in clinical remission)
• Subjects who underwent subtotal colectomy or proctocolectomy prior to adalimumab initiation

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW: collaborator
• Imelda Hospital, Bonheiden: collaborator
• University of Liege: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• AZ Delta: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator
• University Hospital, Ghent: collaborator
• General Hospital Groeninge: collaborator
• Centre Hospitalier Universitaire UCLouvain Namur: collaborator
• Université Catholique de Louvain: collaborator
• Onze Lieve Vrouwziekenhuis Aalst: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marc Ferrante, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: May 5, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

BE (1)