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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003008-19 | EudraCT Number | ||
| U1111-1122-3474 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0215-0384 | Drug | I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 10 weeks after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| I.v. administration: AUC, Area under the curve | Up to 10 weeks after drug administration | |
| I.v. administration: terminal half-life (t½) | Up to 10 weeks after drug administration | |
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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 |
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| 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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| ID | Term |
|---|---|
| C000612951 | NNC0215-0384 |
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| placebo | Drug | Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin). |
|
| NNC0215-0384 | Drug | The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg |
|
| S.c. administration: AUC, Area under the curve |
| Up to 10 weeks after drug administration |
| S.c. administration: terminal half-life (t½) | Up to 10 weeks after drug administration |
| Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils | Up to 10 weeks after drug administration |
| Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA) | Up to 10 weeks after drug administration |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |