Clinical trial NCT04089514: A Real-world Study of Imraldi® Use
Official title: Pan-EU Real-World Experience With Imraldi®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid (RA)
Axial Spondyloarthritis (axSpA)
Arthritis, Psoriatic (PsA)
Crohn's Disease (CD)
Colitis, Ulcerative (UC)
Keywords: Biologics
Non-interventional
Real-world
Adalimumab
Europe
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with RA, or axSpA, or PsA, or CD, or UC, who are receiving biosimilar adalimumab (Imraldi®) therapy for their immune-mediated inflammatory disease.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Candidate Predictors of Persistence on Adalimumab
timeFrame: Baseline up to Week 48
Secondary outcomes:
measure: Number of Participants by Baseline Clinical Characteristic Categories
timeFrame: Baseline
measure: Number of Participants by Utilization of Adalimumab Categories
timeFrame: Baseline up to Week 48
measure: Change from Baseline in Disease Scores as Applicable by Indication
timeFrame: Baseline up to Week 48
measure: Patient Satisfaction with Biologic Administration
timeFrame: Baseline up to Week 48
measure: Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements
timeFrame: Baseline up to Week 48
measure: Number of Participants by Utilization of Relevant Concomitant Medication Categories
timeFrame: Baseline up to Week 48
measure: Number of Participants with Anti-drug Antibodies
timeFrame: Baseline up to Week 48
measure: Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs)
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Herentals
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Sijsele
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bruchhausen-Vilsen
country: Germany
facility: Research Site
city: Burghausen
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Elmshorn
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamm
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Donostia
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Mérida
country: Spain
facility: Research Site
city: Sant Joan Despi
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Ashford
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Kettering
country: United Kingdom
facility: Research Site
city: Luton
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sussex
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: