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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Therapy | Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants by Utilization of Adalimumab Categories |
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Inclusion Criteria:
Exclusion Criteria:
- Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bruges | Belgium | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37632666 | Derived | 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. |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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 |
| 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 |
| Patient Satisfaction with Biologic Administration | Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire. | Baseline up to Week 48 |
| 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 |
| 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 |
| Number of Participants with Anti-drug Antibodies | Participants will be assessed for positive antibody results. | Baseline up to Week 48 |
| 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 |
| Brussels |
| Belgium |
| Research Site | Genk | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Herentals | Belgium |
| Research Site | Kortrijk | Belgium |
| Research Site | Liège | Belgium |
| Research Site | 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 |
| Research Site | Hamburg | Germany |
| Research Site | Hamm | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Munich | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Oldenburg | Germany |
| Research Site | Ratingen | Germany |
| Research Site | Dublin | Ireland |
| Research Site | Ancona | Italy |
| Research Site | Bari | Italy |
| Research Site | Florence | Italy |
| Research Site | Foggia | Italy |
| Research Site | Milan | Italy |
| Research Site | Modena | Italy |
| Research Site | Pavia | Italy |
| Research Site | San Giovanni Rotondo | Italy |
| Research Site | Siena | Italy |
| Research Site | Varese | Italy |
| Research Site | Almería | Spain |
| Research Site | Badajoz | Spain |
| Research Site | Donostia / San Sebastian | Spain |
| Research Site | Granada | Spain |
| Research Site | Mérida | Spain |
| Research Site | Sant Joan Despí | Spain |
| Research Site | Seville | Spain |
| Research Site | Terrassa | Spain |
| Research Site | 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D000089183 | Axial Spondyloarthritis |
| D015535 | Arthritis, Psoriatic |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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