Arthritis, Psoriatic (PsA), Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Colitis, Ulcerative (UC), Crohn's Disease (CD)
Conditions
Keywords
Biologics, Non-interventional, Real-world, Adalimumab, Europe
Brief summary
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.
Interventions
DRUGAdalimumab
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Candidate Predictors of Persistence on Adalimumab | Baseline up to Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Utilization of Adalimumab Categories | Baseline up to Week 48 | Adalimumab utilization categories may include type, dose, dose frequency and mode of administration, any changes, reason(s) for change and/or discontinuation. |
| Change from Baseline in Disease Scores as Applicable by Indication | Baseline up to Week 48 | 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)) |
| Patient Satisfaction with Biologic Administration | Baseline up to Week 48 | Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire. |
| Number of Participants by Baseline Clinical Characteristic Categories | Baseline | Baseline characteristics categories may include age, gender, diagnosis, duration of disease, relevant medical and surgical history, relevant co-morbidities, disease score, relevant concomitant therapies. |
| Number of Participants by Utilization of Relevant Concomitant Medication Categories | Baseline up to Week 48 | Concomitant medication utilization categories may include type, dose, and any changes in use of relevant concomitant therapy. |
| Number of Participants with Anti-drug Antibodies | Baseline up to Week 48 | Participants will be assessed for positive antibody results. |
| Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs) | Baseline up to Week 48 | 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. |
| Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements | Baseline up to Week 48 | Clinical significance will be assessed by the investigator. |
Countries
Belgium, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed