Crohn’s disease
Conditions
Interventions
Trade Name: Imraldi
Product Name: Imraldi
Pharmaceutical Form: Injection
INN or Proposed INN: adalimumab
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Na
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess maintenance of baseline clinical status at both 24 and 48 weeks after initiation of study therapy, when transitioning between Humira (reference adalimumab) and Imraldi (biosimilar adalimumab).;Secondary Objective: 1.To describe subject clinical characteristics and disease status over time 2.To describe adalimumab and relevant concomitant medication use over time 3.To evaluate immunogenicity to adalimumab 4.To describe presence of inflammatory markers over time 5.To describe subject experience and treatment satisfaction over time ;Primary end point(s): The primary outcome measurement of this study is the proportion of subjects maintaining baseline clinical status at week 24 and week 48. Modified Harvey-Bradshaw Index (mHBI) for Crohn’s Disease and IBD Control (IBD-CTRL) Patient Reported Outcome Measure (PROM); increase in mHBI score of =3 and/or a decline in IBD-CTRL score of =4 points at any time during the respective study period will be classified as failure to maintain baseline clinical status;Timepoint(s) of evaluation of this end point: 24 and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To describe subject clinical characteristics and disease status over time: Age, gender, duration of CD, relevant clinical and surgical history, smoking status at baseline; IBD-CTRL, PRO-2 and mHBI over time • To describe adalimumab and relevant concomitant medication use over time: • For biologic therapy: Type, dose, dose frequency and any changes, reason for discontinuation • For relevant concomitant therapy: Type, dose regimen, any changes in use of immunosuppressant, steroid and/or other CD-related medication • To evaluate immunogenicity to adalimumab: Anti-drug antibodies (binding and/or circulating) and drug trough levels at baseline and over time during the study • To describe presence of inflammatory markers over time: Levels of laboratory inflammatory markers (faecal calprotectin, haemoglobin, CRP, albumin, platelets) at baseline and over time during the study • To describe the subject experience and treatment satisfaction over time: Semi-structured interviews analysed using thematic analysis during the study, including Treatment Satisfaction Questionnaire for Medication (TSQM 14) and reporting injection site discomfort using a Visual Analogue Scale (VAS) ;Timepoint(s) of evaluation of this end point: 24 and 48 weeks | — |
Countries
United Kingdom
Contacts
Public ContactDr Fraser Cummings
University Hospital Southampton NHS Foundation Trust
Outcome results
None listed