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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2430 | Other Identifier | WHO | |
| 2009-011791-30 | EudraCT Number |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with 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 |
|---|---|---|---|---|
| NNC 0151-0000-0000 | Drug | Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | at all scheduled visits (week 1 - week 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of NNC 151-0000-0000 | at 48 hours after all dose administrations |
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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 | Prague | 128 50 | Czechia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period |
|
| Frederiksberg |
| 2000 |
| Denmark |
| Novo Nordisk Investigational Site | Silkeborg | 8600 | Denmark |
| Novo Nordisk Investigational Site | Budapest | 1027 | Hungary |
| Novo Nordisk Investigational Site | Bialystok | 15-879 | Poland |
| Novo Nordisk Investigational Site | Elblag | 82-300 | Poland |
| Novo Nordisk Investigational Site | Krakow | 31-637 | Poland |
| Novo Nordisk Investigational Site | Poznan | 61-218 | Poland |
| Novo Nordisk Investigational Site | Bacau | Bacău | 600114 | Romania |
| Novo Nordisk Investigational Site | Cluj-Napoca | Cluj | 400006 | Romania |
| Novo Nordisk Investigational Site | Sfantu Gheorghe | Covasna | 520064 | Romania |
| Novo Nordisk Investigational Site | Bucharest | 011172 | Romania |
| Novo Nordisk Investigational Site | Bucharest | 020475 | Romania |
| Novo Nordisk Investigational Site | Burslem | ST6 7AG | United Kingdom |
| Novo Nordisk Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Novo Nordisk Investigational Site | Swansea | SA6 6NL | United Kingdom |
| 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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