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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000337-31 | EudraCT Number |
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A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozibafusp Alfa | Experimental | Participants will receive rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Rozibafusp alfa doses will range from 70 to 420 mg. Escalation to a higher dose cohort will be contingent on a review indicating that the previous dose regimen has been found to demonstrate an acceptable safety and tolerability profile at a dose level review meeting (DLRM). |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozibafusp Alfa | Drug | Administered by subcutaneous injection once every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria:
| From first dose of study drug to 24 weeks after last dose (up to 34 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. | |
| Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group LLC | Anniston | Alabama | 36207 | United States | ||
| Altoona Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37150935 | Background | Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
The study consisted of 4 multiple ascending dose cohorts. Within each cohort participants were randomized in a 3:1 ratio to receive rozibafusp alfa or placebo. Escalation to a higher dose cohort was contingent on a review to confirm that the previous dose regimen(s) demonstrated an acceptable safety and tolerability profile.
This study was conducted at 4 centers in the United States and Germany. Participants with rheumatoid arthritis were enrolled from 14 August 2017 to 20 February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| FG001 | Rozibafusp Alfa 70 mg | Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| FG002 | Rozibafusp Alfa 140 mg | Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| FG003 | Rozibafusp Alfa 210 mg | Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| FG004 | Rozibafusp Alfa 420 mg | Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of rozibafusp alfa or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| BG001 | Rozibafusp Alfa 70 mg | Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| 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 defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria:
| All randomized participants who received at least 1 dose of rozibafusp alfa or placebo. | Posted | Count of Participants | Participants | From first dose of study drug to 24 weeks after last dose (up to 34 weeks). |
From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
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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 | Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2018 | Jun 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2019 | Jun 22, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000729492 | rozibafusp alfa |
Not provided
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| Placebo | Drug | Administered by subcutaneous injection once every 2 weeks. |
|
| Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
| Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa | Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
| Terminal Half-life of Rozibafusp Alfa | Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
| Accumulation Ratio of AUCtau | Accumulation ratio is the ratio of AUCtau after the last dosing interval (week 10) divided by AUCtau after the first dosing interval (day 1). | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose |
| Accumulation Ratio of Cmax | Accumulation ratio is the ratio of Cmax after the last dosing interval (week 10) divided by Cmax after the first dosing interval (day 1). | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose |
| Duncansville |
| Pennsylvania |
| 16635 |
| United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Charite Research Organisation GmbH | Berlin | 10117 | Germany |
| Lost to Follow-up |
|
| BG002 | Rozibafusp Alfa 140 mg | Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| BG003 | Rozibafusp Alfa 210 mg | Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| BG004 | Rozibafusp Alfa 420 mg | Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| OG001 | Rozibafusp Alfa 70 mg | Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| OG002 | Rozibafusp Alfa 140 mg | Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| OG003 | Rozibafusp Alfa 210 mg | Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
| OG004 | Rozibafusp Alfa 420 mg | Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). |
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa | The pharmacokinetic (PK) parameter analysis set includes all randomized participants who received rozibafusp alfa and for whom PK parameters were adequately estimated. | Posted | Median | Full Range | days | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa | PK parameter analysis set with available data at each time point | Posted | Mean | Standard Deviation | μg/mL | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
|
|
|
| Secondary | Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa | PK parameter analysis set with available data at each time point | Posted | Mean | Standard Deviation | day*μg/mL | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa | PK parameter analysis set with available data at each time point | Posted | Mean | Standard Deviation | day*μg/mL | Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
|
|
|
| Secondary | Terminal Half-life of Rozibafusp Alfa | PK parameter analysis set with available data at each time point | Posted | Mean | Standard Deviation | days | Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose. |
|
|
|
| Secondary | Accumulation Ratio of AUCtau | Accumulation ratio is the ratio of AUCtau after the last dosing interval (week 10) divided by AUCtau after the first dosing interval (day 1). | PK parameter analysis set with available AUCtau data at day 1 and week 10 | Posted | Mean | Standard Deviation | ratio | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose |
|
|
|
| Secondary | Accumulation Ratio of Cmax | Accumulation ratio is the ratio of Cmax after the last dosing interval (week 10) divided by Cmax after the first dosing interval (day 1). | PK parameter analysis set with available Cmax data at day 1 and week 10 | Posted | Mean | Standard Deviation | ratio | Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Rozibafusp Alfa 70 mg | Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). | 0 | 7 | 1 | 7 | 6 | 7 |
| EG002 | Rozibafusp Alfa 140 mg | Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). | 0 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Rozibafusp Alfa 210 mg | Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | Rozibafusp Alfa 420 mg | Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses). | 0 | 7 | 0 | 7 | 7 | 7 |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Deafness bilateral | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Coxsackie viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.0 | 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 |
|
| Week 10 |
|
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| Week 10 |
|
|
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| Week 10 |
|
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