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This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and intravenous (IV) doses in patients with active rheumatoid arthritis (RA) in combination with a stable dose of disease modulating anti-rheumatic drugs (DMARDs). Part A is dose escalation (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of brodalumab from Part A.
The dose-escalation phase consisted of 5 sequentially enrolled dose cohorts. Within each cohort participants were randomly assigned in a 3:1 ratio to receive brodalumab or placebo subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6).
Dose escalations required acceptable safety data based on blinded review following completion of the day 15/week 3 visit by the final participant in each cohort and when six or more participants in a cohort had been administered at least three doses of brodalumab (cohorts 1, 2, 3 and 5). In cohort 6, dose escalation followed completion of the day 15/week 3 visit by the final patient in cohort 5 and six or more participants in cohort 5 had been administered two or more IV infusions of brodalumab.
Cohort 4 was designed to be used in the dose expansion phase to provide evidence of biological impact in 70 patients with RA receiving brodalumab at the dose determined during the dose escalation phase of the study. This cohort was not enrolled because a decision was made not to conduct Part B of the study; instead a separate phase 2 multiple-dose study was conducted to evaluate efficacy of brodalumab in patients with RA (Study 20090061; NCT00950989).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo SC (Cohorts 1-3) | Placebo Comparator | Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. |
|
| Placebo IV (Cohorts 5-6) | Placebo Comparator | Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. |
|
| Brodalumab 50 mg SC (Cohort 1) | Experimental | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
|
| Brodalumab 140 mg SC (Cohort 2) | Experimental | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
|
| Brodalumab 210 mg SC (Cohort 3) | Experimental | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Biological | Solution for subcutaneous or intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard. | From first dose of study drug up to end of study (week 19). |
| Number of Participants With Clinically Significant Changes in Safety Laboratory Tests | The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported. | Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127. |
| Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings | From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6. | |
| Number of Participants With Anti-brodalumab Antibodies | Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab. | Days 1 (pre-dose), 29 (pre-dose), 85, and 127 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. | |
| Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24286136 | Derived | Martin DA, Churchill M, Flores-Suarez L, Cardiel MH, Wallace D, Martin R, Phillips K, Kaine JL, Dong H, Salinger D, Stevens E, Russell CB, Chung JB. A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis. Arthritis Res Ther. 2013 Oct 25;15(5):R164. doi: 10.1186/ar4347. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Within each cohort participants were randomized 3:1 to receive ascending doses of brodalumab or placebo subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6).
Cohort 4 was designed to be used in the dose expansion part of the study, however, this cohort was not enrolled because experimental endpoints would be achieved during a separate phase II study.
This study was conducted at 11 sites: 7 in the United States, 2 in Canada and 2 in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo SC (Cohorts 1-3) | Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. |
| FG001 | Placebo IV (Cohorts 5-6) | Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. |
| FG002 | Brodalumab 50 mg SC (Cohort 1) | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| FG003 | Brodalumab 140 mg SC (Cohort 2) | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| FG004 | Brodalumab 210 mg SC (Cohort 3) | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| FG005 | Brodalumab 420 mg IV (Cohort 5) | Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| FG006 | Brodalumab 700 mg IV (Cohort 6) | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SC (Cohorts 1-3) | Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. |
| BG001 | Placebo IV (Cohorts 5-6) |
| 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 With Treatment-emergent Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard. | All randomized participants who received at least 1 dose of study drug (placebo or brodalumab). | Posted | Count of Participants | Participants | From first dose of study drug up to end of study (week 19). |
|
From first dose of study drug up to end of study (week 19).
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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 | Placebo SC (Cohorts 1-3) | Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Brodalumab 420 mg IV (Cohort 5) |
| Experimental |
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
|
| Brodalumab 700 mg IV (Cohort 6) | Experimental | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
|
|
| Placebo | Other | Solution for subcutaneous or intravenous administration |
|
| After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
| Accumulation Ratio for Brodalumab After Subcutaneous Dosing | Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose). | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
| Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
| Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
| Accumulation Ratio for Brodalumab After Intravenous Dosing | Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose). | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
| BG002 | Brodalumab 50 mg SC (Cohort 1) | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| BG003 | Brodalumab 140 mg SC (Cohort 2) | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| BG004 | Brodalumab 210 mg SC (Cohort 3) | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| BG005 | Brodalumab 420 mg IV (Cohort 5) | Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| BG006 | Brodalumab 700 mg IV (Cohort 6) | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
| OG001 | Placebo IV (Cohorts 5-6) | Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. |
| OG002 | Brodalumab 50 mg SC (Cohort 1) | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| OG003 | Brodalumab 140 mg SC (Cohort 2) | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| OG004 | Brodalumab 210 mg SC (Cohort 3) | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| OG005 | Brodalumab 420 mg IV (Cohort 5) | Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| OG006 | Brodalumab 700 mg IV (Cohort 6) | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
|
|
| Primary | Number of Participants With Clinically Significant Changes in Safety Laboratory Tests | The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127. |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6. |
|
|
|
| Primary | Number of Participants With Anti-brodalumab Antibodies | Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Days 1 (pre-dose), 29 (pre-dose), 85, and 127 |
|
|
|
| Secondary | Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | Participants who received subcutaneously administered brodalumab with available data | Posted | Median | Full Range | days | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
|
|
|
| Secondary | Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses | Participants who received subcutaneously administered brodalumab with available data | Posted | Mean | Standard Deviation | μg/mL | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses | Participants who received subcutaneously administered brodalumab with available data | Posted | Mean | Standard Deviation | days*μg/mL | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
|
|
|
| Secondary | Accumulation Ratio for Brodalumab After Subcutaneous Dosing | Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose). | Participants who received subcutaneously administered brodalumab with available data | Posted | Mean | Standard Deviation | ratio | After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127. |
|
|
|
| Secondary | Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | Participants who received brodalumab by intravenous infusion with available data | Posted | Median | Full Range | hours | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
|
|
|
| Secondary | Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses | Participants who received brodalumab by intravenous infusion with available data | Posted | Mean | Standard Deviation | μg/mL | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses | Participants who received brodalumab by intravenous infusion with available data | Posted | Mean | Standard Deviation | days*μg/mL | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
|
|
|
| Secondary | Accumulation Ratio for Brodalumab After Intravenous Dosing | Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose). | Participants who received brodalumab by intravenous infusion with available data | Posted | Mean | Standard Deviation | ratio | After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127. |
|
|
|
| 1 |
| 6 |
| 3 |
| 6 |
| EG001 | Placebo IV (Cohorts 5-6) | Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. | 0 | 4 | 4 | 4 |
| EG002 | Brodalumab 50 mg SC (Cohort 1) | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. | 0 | 6 | 5 | 6 |
| EG003 | Brodalumab 140 mg SC (Cohort 2) | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. | 0 | 6 | 5 | 6 |
| EG004 | Brodalumab 210 mg SC (Cohort 3) | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. | 0 | 6 | 4 | 6 |
| EG005 | Brodalumab 420 mg IV (Cohort 5) | Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. | 1 | 6 | 5 | 6 |
| EG006 | Brodalumab 700 mg IV (Cohort 6) | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. | 0 | 6 | 4 | 6 |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Complicated migraine | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Administration site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Eschar | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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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 |
| Neutralizing antibodies |
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| Day 29 (last dose) |
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| Day 29 (last dose) |
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| Day 29 (last dose) |
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