A Real-world Study of Imraldi® Use

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU). The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.

Official Title
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Pan-EU Real-World Experience With Imraldi®

Conditions
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Colitis, Ulcerative (UC), Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD)

Intervention / Treatment
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* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initiation on Imraldi® therapy after 18th October 2018, as part of routine treatment immediately after transitioning from at least 16 weeks' treatment with originator adalimumab (Humira®) Availability of at least one Baseline disease score (i.e. within 16 weeks prior or up to 6 weeks post-initiation of Imraldi®) Should provide informed consent to participate in the study Exclusion Criteria: - Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adalimumab Therapy<br>Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy | Drug: Adalimumab<br>* Administered as specified in the treatment arm<br>* Other names: Imraldi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candidate Predictors of Persistence on Adalimumab | Candidate predictors (baseline clinical characteristics, disease score as applicable, incidence and clinical management of flares, and patient satisfaction survey) will be assessed via cox regression which will result in a hazard ratio. | Baseline up to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Baseline Clinical Characteristic Categories | Baseline characteristics categories may include age, gender, diagnosis, duration of disease, relevant medical and surgical history, relevant co-morbidities, disease score, relevant concomitant therapies. | Baseline | 
| Number of Participants by Utilization of Adalimumab Categories | Adalimumab utilization categories may include type, dose, dose frequency and mode of administration, any changes, reason(s) for change and/or discontinuation. | Baseline up to Week 48 | 
| Change from Baseline in Disease Scores as Applicable by Indication | Disease score as applicable by indication may include participant assessments of disease specific questionnaires (e.g. Disease Activity Score- 28 (DAS-28), Bath Ankylosing spondyloarthritis Functional Index (BASDAI), Harvey Bradshaw Index (HBI), Partial Mayo Score, Psoriatic Arthritis Response Criteria (PsARC)) | Baseline up to Week 48 | 
| Patient Satisfaction with Biologic Administration | Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire. | Baseline up to Week 48 | 
| Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements | Clinical significance will be assessed by the investigator. | Baseline up to Week 48 | 
| Number of Participants by Utilization of Relevant Concomitant Medication Categories | Concomitant medication utilization categories may include type, dose, and any changes in use of relevant concomitant therapy. | Baseline up to Week 48 | 
| Number of Participants with Anti-drug Antibodies | Participants will be assessed for positive antibody results. | Baseline up to Week 48 | 
| Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs) | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. | Baseline up to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biologics, Non-interventional, Real-world, Adalimumab, Europe