Trials / Completed
CompletedNCT04089514
A Real-world Study of Imraldi® Use
Pan-EU Real-World Experience With Imraldi®
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Arthritis, Rheumatoid (RA)
- Axial Spondyloarthritis (axSpA)
- Arthritis, Psoriatic (PsA)
- Crohn's Disease (CD)
- Colitis, Ulcerative (UC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab | Administered as specified in the treatment arm |
Timeline
- Start date
- 2019-06-30
- Primary completion
- 2021-11-30
- Completion
- 2021-11-30
- First posted
- 2019-09-13
- Last updated
- 2023-04-18
Locations
54 sites across 6 countries: Belgium, Germany, Ireland, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04089514. Inclusion in this directory is not an endorsement.