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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001492-20 | EudraCT Number | ||
| U1111-1141-3512 | Other Identifier | WHO | |
| REec-2014-0740 | Registry Identifier | Spanish Register of Clinical Studies (REec) |
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This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0109-0012 | Experimental |
| |
| Adalimumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0109-0012 | Drug | Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the total histopathological synovitis score | Week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE) | Week 0, week 12 | |
| Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME) | Week 0, week 12 |
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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 |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Adalimumab | Drug | Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®) |
|
| placebo | Drug | Solution for injection administered subcutaneously (s.c. - under the skin). 1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks). |
|
| Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis | Week 0, week 12 |
| Changes in RA-MRI scores (RAMRIS) of oedema | Week 0, week 12 |
| Changes in RA-MRI scores (RAMRIS) of erosion | Week 0, week 12 |
| Change in high frequency ultrasound with Power Doppler measures of total synovitis | Week 0, week 12 |
| Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores | Week 0, week 12 |
| Change in disease activity 28 - C-reactive protein (DAS28 (CRP) | Week 0, week 12 |
| Incidence of Adverse Events (AE) | Week 0, week 24 |
| Incidence of local intolerability at the injection site | Week 0, week 24 |
| 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 |
|---|---|
| C000600094 | Fletikumab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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