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The main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a standardised participant questionnaire. In addition, it is to be investigated whether differences exist in general participant satisfaction between participant groups who have undergone various prior treatment and/or have previous experience with application systems (participants new to the use of biologics, participants changing over from a prefilled injection or changing over from another pre-filled pen) and between participants of the various indication groups. Furthermore, the participants are to evaluate various aspects of using the Benepali® pre-filled pen based on their personal experience, such as e.g. handling, user-friendliness and features of the Benepali® pre-filled pen, as well as the effectiveness of the training on injection with the Benepali® pre-filled pen, based on participant satisfaction with the training received with the training pen and the evaluation of the training material received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benepali | Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benepali | Biological | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen | The Questionnaire is based on a 5-point Likert scale where 0 = very dissatisfied, 1 = dissatisfied, 2 = neither dissatisfied nor satisfied, 3 = satisfied, 4 = very satisfied. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants that Answered Questions on Their Personal Experience of Various Aspects of Using the Benepali Pre-Filled Pen with a (3) or (4) on a 5-point Likert Scale. | The questions comprise the areas of handling, user-friendliness and features of the Benepali® pre-filled pen, satisfaction compared with the previous application system and satisfaction with the training on injection with the training pen. 0 = worst rating, 4 = best rating. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Altenholz | 24161 | Germany | |||
| Research Site |
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| Day 1 |
| Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials | The participants evaluated the training materials and answered "yes" or "no" to questions regarding the adequate effectiveness, clarity, and extent of information provided. | Day 1 |
| Bad Neuenahr-Ahrweiler |
| 53474 |
| Germany |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Berlin | 10719 | Germany |
| Research Site | Berlin | 12435 | Germany |
| Research Site | Berlin | 12555 | Germany |
| Research Site | Berlin | 13055 | Germany |
| Research Site | Berlin | 13353 | Germany |
| Research Site | Braunschweig | 38100 | Germany |
| Research Site | Coburg | 96450 | Germany |
| Research Site | Cologne | 50825 | Germany |
| Research Site | Dresden | 01109 | Germany |
| Research Site | Düsseldorf | 40211 | Germany |
| Research Site | Ehringshausen | 35630 | Germany |
| Research Site | Erfurt | 99096 | Germany |
| Research Site | Essen | 45326 | Germany |
| Research Site | Giessen | 35392 | Germany |
| Research Site | Göpping | 73033 | Germany |
| Research Site | Halle | 06128 | Germany |
| Research Site | Hamburg | 22767 | Germany |
| Research Site | Homburg | 66424 | Germany |
| Research Site | Jülich | 52428 | Germany |
| Research Site | Kronach | 96317 | Germany |
| Research Site | Leipzig | 04109 | Germany |
| Research Site | Leipzig | 04129 | Germany |
| Research Site | Ludwigshafen | 67069 | Germany |
| Research Site | Magdeburg | 39104 | Germany |
| Research Site | Mansfeld | 06343 | Germany |
| Research Site | Mittelherwigsdorf | 02763 | Germany |
| Research Site | München | 80639 | Germany |
| Research Site | Neuss | 41462 | Germany |
| Research Site | Norderstedt | 22844 | Germany |
| Research Site | Nuremberg | 90443 | Germany |
| Research Site | Offenberg | 77652 | Germany |
| Research Site | Saarbrücken | 66111 | Germany |
| Research Site | Seesen | 38723 | Germany |
| Research Site | Tübingen | 72072 | Germany |
| Research Site | Ulm | 89073 | Germany |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025242 | Spondylarthropathies |
| D013167 | Spondylitis, Ankylosing |
| D000089183 | Axial Spondyloarthritis |
| 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 |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| 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 |
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