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| ID | Type | Description | Link |
|---|---|---|---|
| 202-03 | Other Identifier | Ethical Commission |
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| Name | Class |
|---|---|
| Rheumazentrum Ruhrgebiet | OTHER |
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The study has the aim to investigate the efficacy and safety of etanercept in patients with active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept 25 mg | Experimental | Etanercept 25 mg subcutaneously twice a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept 25 mg subcutaneously twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response | Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained response | Percentage of patients achieving the BASDAI50 response over time | every 3 months througout the study |
| Safety outcome | Percentage of patients experienced adverse event during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Sieper, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumazentrum Ruhrgebiet | Herne | Nordrhrein-Westfalen | 44649 | Germany | ||
| Charite Campus Benjamin Franklin, Rheumatology |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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| at 12 weeks, every 12 weeks thereafter |
| Magnetic resonance imaging (MRI) response | Reduction of inflammation seen on MRI in comparison to baseline | at week 24, 54, 102, 210, 308, 416, 514 |
| X-ray progression | Progression of the spinal structural changes as assessed by x-ray in comparison to baseline | at week 54, 102, 210, 308, 514 |
| Berlin |
| State of Berlin |
| 12203 |
| Germany |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| 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 |