Evaluation of the Safety and Effectiveness of Switching From Humira® to Imraldi® in Flanders

NCT04045782 | Completed Phase 4

• 1 other identifier: SafE-OrBi
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicentre, phase IV, prospective, interventional cohort study to evaluate the safety and effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in routine clinical practice. The study will include approximately 170 patients (100 patients treated in OLV Aalst and 70 patients treated in AZ Maria Middelares Gent). The study collects baseline clinical characteristics and assessment of parameters regarding switch and overall satisfaction. For patients who are willing to switch, there is a 12-month follow-up (study) period. During the follow-up (study) period patients will continue their treatment with adalimumab, i.e. Imraldi®, except if good clinical practice for the patient would oblige the treating physician to change treatment regimen.

Conditions

Inflammatory Bowel Diseases

Keywords

biologic; biosimilar; switch; IBD

Outcome Measures

Primary Outcomes (1)

• Adalimumab (ADA) trough level

  Change from baseline in adalimumab (ADA) through level at month 12

  from Imraldi initiation (baseline) until month 12

Secondary Outcomes (16)

• Adalimumab (ADA) trough level

  from Imraldi initiation (baseline) until month 6

• Association of adalimumab (ADA) trough level with clinical outcome (Secundary loss of Response (SLOR)

  From Imraldi initiation (baseline) until Month 12

• Disease activity scores (Crohn's Disease Activity Index (CDAI) )

  From Imraldi initiation (baseline) until Month 12

• Clinical mayo score

  From Imraldi initiation (baseline) until Month 12

• Physician Global Assessment (PGA)

  From Imraldi initiation (baseline) until Month 12

Study Arms (1)

single arm

OTHER

Adult patients (≥ 18 years of age) with Ulcerative Colitis or Crohn's Disease on maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®.

Drug: single arm

Interventions

single arm DRUG

switch from originator (Humira) to biosimilar (Imraldi)

Also known as: single

single arm

Eligibility Criteria

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

You may qualify if:

• Adult (≥ 18 years of age).
• Ulcerative Colitis or Crohn's disease diagnosis.
• Maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®.
• Able to communicate in Flemish or French or English.
• Able and willing to voluntarily participate in the study and to provide signed informed consent.

You may not qualify if:

• Currently included in an interventional study.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Pieter Dewint, MD PhD: lead

Study Sites (2)

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Maria Middelares Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Single Person

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Pieter Dewint, MD, PhD

  AZ Maria Middelares Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: August 6, 2019
• Study Start: August 19, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

BE (2)