Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013132-20 | EudraCT Number | ||
| U1111-1112-6382 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-IL-20 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-IL-20 | Drug | Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 0 - 21 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal serum half-life | 0 - 21 weeks after dosing | |
| Maximum observed serum concentration (Cmax) | 6 - 10 weeks after dosing | |
| Change in ACR20, ACR50 and ACR70 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Brussels | 1070 | Belgium | |||
| Novo Nordisk Investigational Site |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels. |
|
| 0-21 hours after dosing |
| Warsaw |
| PL-02-274 |
| Poland |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |