Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2019-06-30
2021-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adalimumab Therapy
Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy
Adalimumab
Administered as specified in the treatment arm
Interventions
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Adalimumab
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Bruges, , Belgium
Research Site
Brussels, , Belgium
Research Site
Genk, , Belgium
Research Site
Ghent, , Belgium
Research Site
Herentals, , Belgium
Research Site
Kortrijk, , Belgium
Research Site
Liège, , Belgium
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Sijsele, , Belgium
Research Site
Turnhout, , Belgium
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
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Hamburg, , Germany
Research Site
Hamm, , Germany
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Heidelberg, , Germany
Research Site
Magdeburg, , Germany
Research Site
Munich, , Germany
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München, , Germany
Research Site
Münster, , Germany
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Oldenburg, , Germany
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Ratingen, , Germany
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Dublin, , Ireland
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Ancona, , Italy
Research Site
Bari, , Italy
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Florence, , Italy
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Foggia, , Italy
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Milan, , Italy
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Modena, , Italy
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Pavia, , Italy
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San Giovanni Rotondo, , Italy
Research Site
Siena, , Italy
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Varese, , Italy
Research Site
Almería, , Spain
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Badajoz, , Spain
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Donostia / San Sebastian, , Spain
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Granada, , Spain
Research Site
Mérida, , Spain
Research Site
Sant Joan Despí, , Spain
Research Site
Seville, , Spain
Research Site
Terrassa, , Spain
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Valladolid, , Spain
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, , United Kingdom
Countries
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References
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Muller-Ladner U, Dignass A, Gaffney K, Jadon D, Matucci-Cerinic M, Lobaton T, Carron P, Gisbert JP, Pande I, Utzinger M, Addison J. The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune-Mediated Inflammatory Disease. BioDrugs. 2023 Nov;37(6):873-889. doi: 10.1007/s40259-023-00616-3. Epub 2023 Aug 26.
Other Identifiers
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EUR-BIO-18-11391
Identifier Type: -
Identifier Source: org_study_id
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