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Lack of enrollment.
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The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept + Denosumab | Experimental | Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Administered by subcutaneous injection once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept | The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained). | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. |
| Maximum Observed Serum Concentration (Cmax) of Etanercept | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Serum Concentration (Tmax) of Etanercept | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. | |
| Serum Denosumab Concentration | Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duncansville | Pennsylvania | 16635 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Following determination of eligibility at screening, 19 participants were enrolled into a 4-week run-in period of etanercept 50 mg subcutaneous once-weekly injection to ensure steady-state.
This study was conducted at 2 centers in the United States. The first participant enrolled on 07 March 2011; the last participant was enrolled on 15 June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept + Denosumab | Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept + Denosumab | Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab. |
| 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 | Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept | The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained). | Participants with available AUC data | Posted | Mean | Standard Deviation | day*μg/mL | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. |
|
From first dose of etenercept in the run-in period (day -28) until end of study (day 176).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Etanercept 50 mg Day - 28 - Day 7 | Participants received etanercept 50 mg subcutaneously once weekly. Adverse events are reported from day -28 until day 7. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
Not provided
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001172 | Arthritis, Rheumatoid |
| D010024 | Osteoporosis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Denosumab | Drug | Administered by subcutaneous injection |
|
|
| Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations | Baseline (Day 8) and Days 22, 29, 85, and 176 |
| Dallas |
| Texas |
| 75231 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) of Etanercept | Participants with available Cmax data | Posted | Mean | Standard Deviation | μg/mL | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. |
|
|
|
|
| Secondary | Time to Maximum Serum Concentration (Tmax) of Etanercept | Participants with available Tmax data | Posted | Median | Full Range | days | Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. |
|
|
|
| Secondary | Serum Denosumab Concentration | Participants with available data | Posted | Mean | Standard Deviation | μg/mL | Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29 |
|
|
|
| Secondary | Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations | Participants with available data at baseline (19) and each time point (indicated by n) | Posted | Median | Inter-Quartile Range | percent change | Baseline (Day 8) and Days 22, 29, 85, and 176 |
|
|
|
| 0 |
| 19 |
| 13 |
| 19 |
| EG001 | Etanercept 50 mg + Denosumab 60 mg Day 8 - EOS | Participants received etanercept 50 mg subcutaneously once weekly. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab. Adverse events are reported from day 8 to end of study (day 176). | 0 | 19 | 2 | 19 |
| EG002 | All Subjects On-study | Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab. Adverse events are reported from day -28 up to day 176. | 0 | 19 | 13 | 19 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fracture treatment | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
|
| Title | Measurements |
|---|
|
| Day 176/End of Study (n = 19) |
|