A Real-world Study of Imraldi® Use

NCT04089514 | Completed FDA Drug

• 1 other identifier: EUR-BIO-18-11391
• Study Type: observational
• Target: 1,000
• Locations: 6 countries
• Sites: 54

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants by Baseline Clinical Characteristic Categories

  Baseline

• Number of Participants by Utilization of Adalimumab Categories

  Baseline up to Week 48

• Change from Baseline in Disease Scores as Applicable by Indication

  Baseline up to Week 48

• Patient Satisfaction with Biologic Administration

  Baseline up to Week 48

• Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements

  Baseline up to Week 48

Study Arms (1)

Adalimumab Therapy

Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy

Drug: Adalimumab

Interventions

Adalimumab DRUG

Administered as specified in the treatment arm

Also known as: Imraldi

Adalimumab Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator

Sponsors & Collaborators

• Biogen: lead

Study Sites (54)

Research Site

Bruges, Belgium

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Brussels, Belgium

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Genk, Belgium

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Ghent, Belgium

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Herentals, Belgium

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Kortrijk, Belgium

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Liège, Belgium

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Sijsele, Belgium

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Turnhout, Belgium

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Berlin, Germany

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Bruchhausen-Vilsen, Germany

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Burghausen, Germany

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Dresden, Germany

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Elmshorn, Germany

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Erfurt, Germany

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Halle, Germany

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Hamburg, Germany

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Hamm, Germany

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Heidelberg, Germany

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Magdeburg, Germany

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Munich, Germany

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München, Germany

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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

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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

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Siena, Italy

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Varese, Italy

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Almería, Spain

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Badajoz, Spain

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Donostia / San Sebastian, Spain

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Granada, Spain

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Mérida, Spain

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Sant Joan Despí, Spain

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Seville, Spain

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Terrassa, Spain

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Valladolid, Spain

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Ashford, United Kingdom

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Bath, United Kingdom

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Belfast, United Kingdom

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Cambridge, United Kingdom

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Kettering, United Kingdom

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Luton, United Kingdom

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Norwich, United Kingdom

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Nottingham, United Kingdom

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Sussex, United Kingdom

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Related Publications (1)

• 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.

  PMID: 37632666 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Axial Spondyloarthritis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: June 30, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (16); BE (9); IT (10); ES (9); IE (1); GB (9)