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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003037-33 | EudraCT Number | ||
| U1111-1122-4067 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0114-0006 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0114-0006 | Drug | Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | From first administration of trial product (week 1) and up until week 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of total IL-21 from first administration of trial product | Week 1, week 27 | |
| Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP) | From week 1 to week 9 (8 weeks after initiation of treatment) |
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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 | Berlin | 10117 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Wagner F, Skrumsager B, Fitilev S. Safety and tolerability of NNC0114-0006, an anti-IL-21 monoclonal antibody, at multiple s.c. dose levels in patients with rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 1492 |
| 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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| placebo | Drug | Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. |
|
| Moscow |
| 117556 |
| Russia |
| Novo Nordisk Investigational Site | Moscow | 119435 | Russia |
| Novo Nordisk Investigational Site | Moscow | 125284 | Russia |
| Novo Nordisk Investigational Site | Yaroslavl | 150003 | Russia |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |