A Real-world Study of Imraldi® Use

Biogen1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (54)

Research Site

Bruges, Belgium

Research Site

Brussels, Belgium

Research Site

Genk, Belgium

Research Site

Ghent, Belgium

Research Site

Herentals, Belgium

Research Site

Kortrijk, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to Week 48

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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))

Time frame: Baseline up to Week 48

Patient Satisfaction with Biologic Administration

Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire.

Time frame: 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.

Time frame: 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.

Time frame: Baseline up to Week 48

Number of Participants with Anti-drug Antibodies

Participants will be assessed for positive antibody results.

Time frame: 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.

Time frame: Baseline up to Week 48