E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Crohn's disease is a lifelong condition in which parts of the digestive system become inflamed. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial will be defined as the last subject’s last visit (LVLS) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 18 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 18 |