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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005529-13 | EudraCT Number | ||
| EudraCT No: 2008-005529-13 |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, HV | Experimental | Dose cohort 1 (3 subjects active, 1 placebo) |
|
| B, HV | Experimental | Dose cohort 2 (3 subjects active, 1 placebo) |
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| C, HV | Experimental | Dose cohort 3 (3 subjects active, 1 placebo) |
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| D, HV | Experimental | Dose cohort 4 (3 subjects active, 1 placebo) |
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| E, HV | Experimental | Dose cohort 5 (3 subjects active, 1 placebo) |
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| A, RA | Experimental | Dose cohort 1 (3 subjects active, 1 placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-IL-20 | Drug | Single s.c. injection (per dose cohort) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, including injection site tolerability | during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal serum half-life (t½) | during treatment | |
| Maximum observed serum concentration (Cmax) | during treatment | |
| Time to reach maximum serum concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25749867 | Result | Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| B, RA | Experimental | Dose cohort 2 (3 subjects active, 1 placebo) |
|
| C, RA | Experimental | Dose cohort 3 (3 subjects active, 1 placebo) |
|
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| placebo | Drug | Single s.c. injection (per dose cohort) |
|
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| during treatment |
| Area under the serum concentration-time curve (AUC0-t and AUC) | during treatment |
| Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable) | during treatment |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |