Patient experience of transitioning between two brands of adalimumab (Humira and a biosimilar – Imraldi) in the treatment of adults with Crohn’s disease

Phase 4

• Conditions: Digestive System; Crohn disease [regional enteritis]; Crohn’s disease

• Registration Number: ISRCTN11094929
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-24
• Last Update Posted: 21 January 2020
• Study Completion: 2021-03-04

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. 18 years and over with a confirmed diagnosis of Crohn’s Disease
2. Stable dose of Humira over the 12 weeks prior to enrolment
3. mHBI < 8 at baseline
4. Anticipated to remain on the same adalimumab administration frequency for the duration of the study
5. Able to comply with study requirements
6. Able to provide informed consent

Exclusion Criteria

1. Less than 18 years of age at enrolment
2. Not anticipated to remain on adalimumab therapy for more than 3 months after randomisation
3. Allergic to any of the known excipients of Humira or Imraldi
4. Scheduled for a surgical procedure or planned hospitalisation within 12 months of randomisation
5. Unable to comply with study requirements
6. Inability to provide consent
7. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified