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| Name | Class |
|---|---|
| Samsung Bioepis Co., Ltd. | INDUSTRY |
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The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.
The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With RA | Participants with RA previously treated with Enbrel and transitioned to Benepali |
| |
| With axSpA | Participants with axSpA previously treated with Enbrel and transitioned to Benepali |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benepali | Biological | As specified in the treatment arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from transition point in Disease Activity Score (DAS-28 score) | Score of 28 joints examined | Approximately 3 months after the transition |
| Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score | Mean BASDAI score | Approximately 3 months after the transition |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the DAS-28 score over time from the value obtained at the Transition Point | Score of 28 joints examined | Approximately 3 and 6 months after the transition |
| Proportion of participants with low disease activity or remission over time following Transition Point |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | München | Bavaria | 80639 | Germany |
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| Label | URL |
|---|---|
| Manuscript description | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Enbrel |
| Biological |
As specified in the treatment arm |
|
|
Defined as DAS-28 score ≤ 3.2 or ≤ 2.6 |
| Approximately 3 and 6 months after the transition |
| Proportion of participants with worsening disease over time following Transition Point | Defined by an increase in DAS-28 of ≥ 1.2, and a minimum DAS score of 3.2 | Approximately 3 and 6 months after the transition |
| Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point | Improvement of ≥ 1.2 points in DAS-28 score data collected | Approximately 3 and 6 months after the transition |
| Change in the General Health Score (assessed using VAS) over time following transition point | Assessed using Visual Analogue Scale (VAS) over time | Approximately 3 and 6 months after the transition |
| Change in the BASDAI score over time from the value obtained at the Transition Point | BASDAI score | Approximately 3 and 6 months after the transition |
| Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point | (ASDAS-ESR ) or (CRP) score | Approximately 3 and 6 months after the transition |
| Proportion of participants with worsening disease over time following Transition Point | Defined by an increase in ASDAS score of ≥1.1, and a minimum ASDAS score of 2.1 | Approximately 3 and 6 months after the transition |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Safety surveillance | Approximately 3 and 6 months after the transition |
| Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point | Assessed using Disease activity-VAS score | Approximately 3 and 6 months after the transition |
| Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point | Assessed using PAIN-VAS score | Approximately 3 and 6 months after the transition |
| Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point | Assessed using FATIGUE - VAS score | Approximately 3 and 6 months after the transition |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point | Assessed using the HAQ-DI score | Approximately 3 and 6 months after the transition |
| Change in PAIN-VAS score over time from the value obtained at the Transition Point | Assessed using Pain - VAS score | Approximately 3 and 6 months after the transition |
| Change in FATIGUE -VAS score over time from the value obtained at the Transition Point | Assessed using FATIGUE - VAS score | Approximately 3 and 6 months after the transition |
| Change in HAQ-DI score over time from the value obtained at the Transition Point | Assessed using the HAQ-DI score | Approximately 3 and 6 months after the transition |
| Number of Participants by Demographic Category | At baseline and approximately 3 and 6 months after the transition |
| Number of Participants by Relevant Medical History | At baseline and approximately 3 and 6 months after the transition |
| Number of Participants by Disease Status | At baseline and approximately 3 and 6 months after the transition |
| Number of Participants by Relevant Medication Use | At baseline and approximately 3 and 6 months after the transition |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |