Not provided
Not provided
Not provided
Not provided
Not provided
the study was terminated because of slow enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Immunex Corporation | INDUSTRY |
The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Etanercept | Experimental | Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. |
|
| Part 2: Placebo | Placebo Comparator | Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. |
|
| Part 2: Etanercept | Experimental | Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months. |
|
| Part 3: | Experimental | Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Administered by subcutaneous injection twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Part 2 With Disease Flare | Disease flare was defined as the presence of:
Major Criteria:
Laboratory Criteria: All labs should be outside the normal range and with 30% worsening:
| 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug. | |
| Time to Flare in Part 2 |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
| FDA-approved Drug Labeling | View source |
Not provided
Participants who responded in Part 1A or 1B were randomized into Part 2, stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they received in Part 1. Participants entered Part 3 only if they had either flared in Part 2 or had completed 3 months of treatment in Part 2. Participants who did not respond in Part 1A or 1B were withdrawn.
Participants with systemic onset juvenile rheumatoid arthritis (SOJRA) were enrolled at 7 sites in the United States and 4 sites in Canada.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Etanercept | Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. |
| FG001 | Part 2: Placebo | Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. |
| FG002 | Part 2: Etanercept | Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months. |
| FG003 | Part 3: Etanercept | Participants who experienced a flare in Part 2 or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including Part 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1A |
|
| ||||||||||||||||||
| Part 1B |
| |||||||||||||||||||
| Part 2 |
| |||||||||||||||||||
| Part 3 |
|
All enrolled participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Etanercept | Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. |
| 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 | Number of Participants in Part 2 With Disease Flare | Disease flare was defined as the presence of:
Major Criteria:
Laboratory Criteria: All labs should be outside the normal range and with 30% worsening:
| Participants randomized into Part 2 who received at least 1 dose of study drug in Part 2 (placebo or etanercept). | Posted | Count of Participants | Participants | 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10) |
Part 1A, maximum duration on treatment was 207 days. Part 1B, maximum duration on treatment was 120 days Part 2, maximum duration on treatment was 88 days Part 3, maximum duration on treatment was 130 days Plus one month after the last dose of study drug.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1A: Etanercept 0.4 mg/kg | Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D005334 | Fever |
| D005076 | Exanthema |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered by subcutaneous injection twice a week |
|
Time to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2. |
| From first dose in Part 1 to the end of Part 2 (up to 13 months) |
| Change From Baseline in Physician Global Assessment of Disease Severity in Part 1 | Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in Physician Global Assessment of Disease Severity in Part 2 | Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Baseline and months 5, 6, 7, 8, and 9 |
| Change From Baseline in Patient's/Parent's Global Assessment in Part 1 | Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2 | Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Baseline and months 5, 6, 7, 8, and 9 |
| Change From Baseline in Number of Active Joints in Part 1 | Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth. | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in Number of Active Joints in Part 2 | Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth. | Baseline and months 5, 6, 7, 8, and 9 |
| Change From Baseline in Number of Joints With Limitation of Motion in Part 1 | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in Number of Joints With Limitation of Motion in Part 2 | Baseline and months 5, 6, 7, 8, and 9 |
| Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1 | Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do). | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 | Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do). | Baseline and months 5, 6, 7, 8, and 9 |
| Change From Baseline in C-reactive Protein (CRP) Levels in Part 1 | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
| Change From Baseline in C-reactive Protein (CRP) Levels in Part 2 | Baseline and months 5, 6, 7, 8, and 9 |
| Lack of Efficacy |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Part 2: Placebo | Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. |
| OG001 | Part 2: Etanercept | Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months. |
|
|
| Secondary | Number of Participants With Adverse Events | Participants who entered each part of the study and received study drug in each part of the study. | Posted | Count of Participants | Participants | Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug. |
|
|
|
| Secondary | Time to Flare in Part 2 | Time to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2. | Participants randomized in Part 2 with a flare in Part 2 | Posted | Median | Full Range | days | From first dose in Part 1 to the end of Part 2 (up to 13 months) |
|
|
|
| Secondary | Change From Baseline in Physician Global Assessment of Disease Severity in Part 1 | Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Physician Global Assessment of Disease Severity in Part 2 | Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Patient's/Parent's Global Assessment in Part 1 | Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2 | Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms). | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Number of Active Joints in Part 1 | Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth. | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | active joints | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Number of Active Joints in Part 2 | Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth. | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | active joints | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Number of Joints With Limitation of Motion in Part 1 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | joints | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Number of Joints With Limitation of Motion in Part 2 | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | joints | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1 | Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do). | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 | Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do). | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | units on a scale | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in C-reactive Protein (CRP) Levels in Part 1 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |
|
|
|
| Secondary | Change From Baseline in C-reactive Protein (CRP) Levels in Part 2 | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | Posted | Mean | Standard Deviation | mg/dL | Baseline and months 5, 6, 7, 8, and 9 |
|
|
|
| 3 |
| 19 |
| 18 |
| 19 |
| EG001 | Part 1B: Etanercept 0.8 mg/kg | Participants who had a partial response in Part 1A entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. | 1 | 8 | 4 | 8 |
| EG002 | Part 2: Placebo | Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months in Part 2. | 0 | 5 | 4 | 5 |
| EG003 | Part 2: Etanercept 0.4/0.8 mg/kg | Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months in Part 2. | 0 | 4 | 3 | 4 |
| EG004 | Part 3: Etanercept 0.4/0.8 mg/kg | Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment received in Part 2. | 0 | 9 | 5 | 9 |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cheilosis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Epstein-Barr viraemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.0 | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| 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 |
| Infectious adverse events |
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|
|
| Month 3 |
|
|
| Month 4 |
|
|
| Month 5 |
|
|
| Month 6 |
|
|
| Month 7 |
|
| Month 8 |
|
| Month 9 |
|
| Month 6 |
|
|
| Month 7 |
|
|
| Month 8 |
|
|
| Month 9 |
|
|