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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-1136 | Other Identifier | WHO | |
| 2010-021283-14 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC109-0012 | Drug | The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) | week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal serum half-life (t½) | end of treatment period | |
| Serum levels of NNC109-0012 | end of treatment period |
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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 | Brno | 602 00 | Czechia | |||
| 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. | |
| 25707477 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin) |
|
| Prague |
| 128 50 |
| Czechia |
| Novo Nordisk Investigational Site | Prague | 140 00 | Czechia |
| Novo Nordisk Investigational Site | Uherské Hradiště | 686 01 | Czechia |
| Novo Nordisk Investigational Site | Zlín | 760 01 | Czechia |
| Novo Nordisk Investigational Site | Berlin | 14059 | Germany |
| Novo Nordisk Investigational Site | Mainz | 55131 | Germany |
| Novo Nordisk Investigational Site | Würzburg | 97080 | Germany |
| Novo Nordisk Investigational Site | Pavia | 27100 | Italy |
| Novo Nordisk Investigational Site | Bialystok | 15-296 | Poland |
| Novo Nordisk Investigational Site | Bialystok | 15-351 | Poland |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-021 | Poland |
| Novo Nordisk Investigational Site | Bytom | 41-902 | Poland |
| Novo Nordisk Investigational Site | Elblag | 82-300 | Poland |
| Novo Nordisk Investigational Site | Gmina Końskie | 26-200 | Poland |
| Novo Nordisk Investigational Site | Poznan | 60-218 | Poland |
| Novo Nordisk Investigational Site | Żyrardów | 96-300 | Poland |
| Novo Nordisk Investigational Site | Lisbon | 1649-035 | Portugal |
| Novo Nordisk Investigational Site | Cluj-Napoca | Cluj | 400006 | Romania |
| Novo Nordisk Investigational Site | Targoviste | Dâmbovița County | 130095 | Romania |
| Novo Nordisk Investigational Site | Ploieşti | Prahova | 100550 | Romania |
| Novo Nordisk Investigational Site | Brăila | 810019 | Romania |
| Novo Nordisk Investigational Site | A Coruña | 15006 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08036 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15706 | Spain |
| Novo Nordisk Investigational Site | Seville | 41009 | Spain |
| Novo Nordisk Investigational Site | Cambridge | CB2 0QQ | United Kingdom |
| Novo Nordisk Investigational Site | Leeds | LS7 4SA | United Kingdom |
| Novo Nordisk Investigational Site | Norwich | NR4 7UY | United Kingdom |
| Senolt L, Leszczynski P, Dokoupilova E, Gothberg M, Valencia X, Hansen BB, Canete JD. Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomized Phase IIa Trial. Arthritis Rheumatol. 2015 Jun;67(6):1438-48. doi: 10.1002/art.39083. |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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