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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005376-42 | EudraCT Number | ||
| U1111-1125-6552 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0114-0006 | Drug | Two i.v. (intravenous) doses administered 6 weeks apart. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP) | Week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) | Week 12 | |
| Incidence of adverse events (AEs) | Up to week 24 | |
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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 | Plovdiv | 4002 | Bulgaria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Canete J, Leszczynski P, Riisbro R, Frederiksen K. Efficacy and safety of NNC0114-0006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 947 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo |
| Drug |
Two i.v. (intravenous) doses administered 6 weeks apart. |
|
| Incidence of antibodies against NNC0114-0006 |
| Up to Week 24 |
| Terminal serum half-life (t½) | After second dose administration at week 6 |
| Change in serum levels of total interleukin-21 (IL-21) | Up to week 12 |
| Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI) | Week 0, week 12 |
| Sevlievo |
| 5400 |
| Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1233 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1606 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1612 | Bulgaria |
| Novo Nordisk Investigational Site | Budapest | 1036 | Hungary |
| Novo Nordisk Investigational Site | Debrecen | 4032 | Hungary |
| Novo Nordisk Investigational Site | Debrecen | 4043 | Hungary |
| Novo Nordisk Investigational Site | Szikszó | 3800 | Hungary |
| Novo Nordisk Investigational Site | Veszprém | 8200 | Hungary |
| Novo Nordisk Investigational Site | Riga | 1038 | Latvia |
| Novo Nordisk Investigational Site | Bialystok | 15-351 | Poland |
| Novo Nordisk Investigational Site | Bydgoszcz | 85-168 | Poland |
| Novo Nordisk Investigational Site | Bytom | 41-902 | Poland |
| Novo Nordisk Investigational Site | Elblag | 82-300 | Poland |
| Novo Nordisk Investigational Site | Katowice | 40-954 | Poland |
| Novo Nordisk Investigational Site | Poznan | 60-218 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-256 | Poland |
| Novo Nordisk Investigational Site | Kazan' | 420103 | Russia |
| Novo Nordisk Investigational Site | Kursk | 305007 | Russia |
| Novo Nordisk Investigational Site | Moscow | 119991 | Russia |
| Novo Nordisk Investigational Site | Skt Petersburg | 194044 | Russia |
| Novo Nordisk Investigational Site | Skt Petersburg | 196084 | Russia |
| Novo Nordisk Investigational Site | Skt. Petersburg | 191025 | Russia |
| Novo Nordisk Investigational Site | Skt. Petersburg | 191186 | Russia |
| Novo Nordisk Investigational Site | Yaroslavl | 150051 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Belgrade | 11080 | Serbia |
| Novo Nordisk Investigational Site | Niška Banja | 18205 | Serbia |
| Novo Nordisk Investigational Site | A Coruña | 15006 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08036 | Spain |
| Novo Nordisk Investigational Site | Elche | 3203 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| 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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