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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003969-18 | EudraCT Number | ||
| U1111-1133-7983 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental |
| |
| Dose level 2 | Experimental |
| |
| Dose level 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0215-0384 | Drug | A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | From first dosing until 19 weeks after first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of NNC0215-0384 in serum | 7 days after each dose | |
| Concentration of NNC0215-0384 in serum | 3 days after first and last dose | |
| Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline |
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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 |
|---|---|---|---|---|---|---|
| Berlin | 13353 | Germany | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| placebo | Drug | Placebo administered corresponding to NNC0215-0384 treatment |
|
| From week 0 until 19 weeks after first dosing |
| Change in health assessment questionnaire - disability index (HAQ-DI) from baseline | Week 0, week 7 first dosing |
| Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity | From first dosing until 19 weeks after first dosing |
| Budapest |
| H1027 |
| Hungary |
| Krakow | 31-637 | Poland |
| Moscow | 119435 | Russia |
| 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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| ID | Term |
|---|---|
| C000612951 | NNC0215-0384 |
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