A Real-world Study of Imraldi® Use

Crohn's Disease (CD) Clinical Trial

— PROPER  

Official title:

Pan-EU Real-World Experience With Imraldi®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089514
• Other study ID #: EUR-BIO-18-11391
• Status: Completed
• Start date: June 30, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Adalimumab
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Belgium	Research Site	Brugge
Belgium	Research Site	Bruxelles
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Herentals
Belgium	Research Site	Kortrijk
Belgium	Research Site	Liège
Belgium	Research Site	Sijsele
Belgium	Research Site	Turnhout
Germany	Research Site	Berlin
Germany	Research Site	Bruchhausen-Vilsen
Germany	Research Site	Burghausen
Germany	Research Site	Dresden
Germany	Research Site	Elmshorn
Germany	Research Site	Erfurt
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hamm
Germany	Research Site	Heidelberg
Germany	Research Site	Magdeburg
Germany	Research Site	Munchen
Germany	Research Site	Munich
Germany	Research Site	Münster
Germany	Research Site	Oldenburg
Germany	Research Site	Ratingen
Ireland	Research Site	Dublin
Italy	Research Site	Ancona
Italy	Research Site	Bari
Italy	Research Site	Firenze
Italy	Research Site	Foggia
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Pavia
Italy	Research Site	San Giovanni Rotondo
Italy	Research Site	Siena
Italy	Research Site	Varese
Spain	Research Site	Almeria
Spain	Research Site	Badajoz
Spain	Research Site	Donostia
Spain	Research Site	Granada
Spain	Research Site	Mérida
Spain	Research Site	Sant Joan Despi
Spain	Research Site	Sevilla
Spain	Research Site	Terrassa
Spain	Research Site	Valladolid
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Kettering
United Kingdom	Research Site	Luton
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Belgium,  Germany,  Ireland,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patient Satisfaction with Biologic Administration	Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire.	Baseline up to Week 48
Secondary	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
Secondary	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
Secondary	Number of Participants with Anti-drug Antibodies	Participants will be assessed for positive antibody results.	Baseline up to Week 48
Secondary	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