Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over Study
- Conditions
- Crohn’s diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-004967-30-GB
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
Subjects with the following characteristics are eligible for this study:
•18 years and over with a confirmed diagnosis of Crohn’s Disease
•Stable dose of Humira over the 12 weeks prior to enrolment
•mHBI < 8 at baseline
•Anticipated to remain on the same adalimumab administration frequency for the duration of the study
•Able to comply with study requirements
•Able to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Subjects with the following characteristics are ineligible for this study:
•Less than 18 years of age at enrolment
•Not anticipated to remain on adalimumab therapy for more than 3 months after randomisation
•Allergic to any of the known excipients of Humira or Imraldi
•Scheduled for a surgical procedure or planned hospitalisation within 12 months of randomisation
•Unable to comply with study requirements
•Inability to provide consent
•Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method