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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-9194 | Other Identifier | WHO | |
| 2010-019261-28 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4.0 mg/kg | Experimental | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
|
| Placebo | Placebo Comparator | Subjects received a single dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0142-0002 | Drug | A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DAS28-CRP After 12 Weeks of Treatment | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment. | Week 0, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DAS28-CRP After 6 Weeks of Treatment. | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment. | Week 0, Week 6 |
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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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The trial was conducted at 8 trial sites in 3 different countries (Germany, the Russian Federation and Ukraine) as follows: Germany: 1 site, the Russian Federation: 6 sites and Ukraine: 1 site. All sites enrolled, randomised and dosed at least 1 subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4.0 mg/kg | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
| FG001 | Placebo | Subjects received a single dose of placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4.0 mg/kg | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
| BG001 | Placebo | Subjects received a single dose of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in DAS28-CRP After 12 Weeks of Treatment | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment. | Change in DAS28-CRP was calculated by using last observation carried forward method. | Posted | Mean | Standard Deviation | scores | Week 0, Week 12 |
|
The adverse events were collected from dosing until end of trial (a total of 24 weeks)
Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4.0 mg/kg | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis erosive | Gastrointestinal disorders | medDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection viral | Infections and infestations | medDRA 14.1 | Systematic Assessment |
As per protocol, this clinical proof-of-principle trial investigated a limited number of participants and doses (single-dose regimen).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | RA-RNDUS-ClinTriDisc@ITS.JNJ.com |
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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 |
|---|---|
| C000624132 | NNC0142-0002 monoclonal antibody |
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| placebo | Drug | A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
|
| Change in DAS28-CRP After 24 Weeks of Treatment. | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment. | Week 0, Week 24 |
| Moscow |
| 109240 |
| Russia |
| Kiev | 03680 | Ukraine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| DAS28-CRP (Disease Activity Score based on count of 28 joints and the C-reactive protein) | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease | Mean | Standard Deviation | scores |
|
|
|
|
| Secondary | Change in DAS28-CRP After 6 Weeks of Treatment. | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment. | Change in DAS28-CRP was calculated by using last observation carried forward method. | Posted | Mean | Standard Deviation | scores | Week 0, Week 6 |
|
|
|
|
| Secondary | Change in DAS28-CRP After 24 Weeks of Treatment. | DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment. | Change in DAS28-CRP was calculated by using last observation carried forward method. | Posted | Mean | Standard Deviation | scores | Week 0, Week 24 |
|
|
|
|
| 3 |
| 41 |
| 5 |
| 41 |
| EG001 | Placebo | Subjects received a single dose of placebo | 1 | 22 | 5 | 22 |
| Pancreatitis chronic | Gastrointestinal disorders | medDRA 14.1 | Systematic Assessment |
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| Portal hypertension | Hepatobiliary disorders | medDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | medDRA 14.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | medDRA 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | medDRA 14.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | medDRA 14.1 | Systematic Assessment |
|
Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |