A Study to Evaluate the Pharmacokinetics, Safety and Immu... | NCT06262477

Label	Type	Description	Intervention Names
BIIB800	Experimental	Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.	Drug: BIIB800
Actemra	Experimental	Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.	Drug: Actemra

Name	Type	Description	Arm Group Labels	Other Names
BIIB800	Drug	Administered as specified in the treatment arm.	BIIB800

Measure	Description	Time Frame
Maximum Observed Serum Concentration (Cmax) of Tocilizumab		Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab		Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab		Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Measure	Description	Time Frame
Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab		Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra		Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fortrea Clinical Research Unit Inc.		Daytona Beach	Florida	32117	United States
Fortrea Clinical Research Unit Inc.

ID	Title	Description
FG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
FG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 6, 2023	Aug 4, 2025

ID	Title	Description
BG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
BG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000150 BG001150 BG002300

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

Maximum Observed Serum Concentration (Cmax) of Tocilizumab

The pharmacokinetic analysis set (PKAS) included all randomized study participants with at least one evaluable pharmacokinetic (PK) parameter. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliter (μg/mL)

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000150 OG001148

Title

Denominators

Categories

Title	Measurements
	OG00010.5± 43.3 OG00110.0± 41.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Ratio of GLSM	1.05			2-Sided	90.3	0.974	1.13					Equivalence	The natural log (ln)- transformed Cmax was analysed using analysis of covariance (ANCOVA) model, which included actual treatment & body weight category (<75 kilograms [kg], ≥75 kg) as factors. The ratio of geometric least square means (GLSM), and corresponding confidence interval (CI) was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.

Primary

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab

The PKAS included all randomized study participants with at least one evaluable PK parameter. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours (h)*μg/ mL

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Primary

Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab

Posted

Geometric Mean

Geometric Coefficient of Variation

h*μg/ mL

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab

Posted

Median

Full Range

hours

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour (L/h)

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Apparent Terminal Half-Life (t1/2) of BIIB800 and Actemra

Posted

Median

Full Range

hours

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has received a pharmaceutical product, regardless of causal relationship with the product. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease which is temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE that starts during or after dosing or starts prior to dosing and increases in severity after dosing. An SAE is any untoward medical occurrence that results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, is a medically important event.

The safety analysis set (SAFS) included all randomized study participants who received the study drug.

Posted

Count of Participants

Participants

From the first dose of study drug up to the end of the study (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra

Secondary

Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)

sIL-6R levels were determined using a validated immunoassay method based on ProteinSimple Ella.

The pharmacodynamics analysis set (PDAS) included all randomized study participants with at least one evaluable pharmacodynamic (PD) parameter i.e., sIL-6R and/or high sensitivity C-reactive protein (hsCRP). 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure.

Posted

Mean

Standard Deviation

hours*nanograms per milliliter (h*ng/mL)

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants

Secondary

Maximum Observed Effect (Emax) of sIL-6R

The PDAS included all randomized study participants with at least one evaluable PD parameter i.e., sIL-6R and/or hsCRP. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Time to Emax (tEmax) of sIL-6R

Posted

Median

Full Range

hours

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

AUE of High Sensitivity C-Reactive Protein (hsCRP)

hsCRP was determined using a particle enhanced immunoturbidometric assay.

Posted

Mean

Standard Deviation

hours*milligrams per liter (h*mg/L)

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Minimum Observed Effect (Emin) of hsCRP

Posted

Mean

Standard Deviation

milligrams per liter (mg/L)

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Time to Emin (tEmin) of hsCRP

Posted

Median

Full Range

hours

Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive Tocilizumab Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Status

The ADA-positive status was determined as a participant with either a pre-existing ADA-positive status (an ADA-positive sample at baseline [prior to administration of study treatment]) or a treatment-induced ADA-positive status (a participant with a negative ADA sample at baseline [pre-dose] and at least one ADA-positive sample after the administration of the study treatment. The nAb-positive status was determined in the same manner that of ADA status. ADA and nAb were analyzed in human serum using validated electrochemiluminescence (ECL) assays based on the MesoScale Discovery platform and were measured using validated ECL methods.

The SAFS included all randomized study participants who received the study drug.

Posted

Count of Participants

Participants

Day 1 to Day 57

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Secondary

Geometric Mean Titer of Anti-drug Antibodies (ADA)

ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample.

The SAFS included all randomized study participants who received the study drug. 'Overall number of participants analyzed' indicates the number of participants with positive ADA. 'Number analyzed (n)' signifies the number of participants evaluable for the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

titre

Pre-dose, Days 15, 29, 57

ID	Title	Description
OG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
OG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG00013 affected150 at risk EG00116 affected150 at risk
Dizziness	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0014 affected150 at risk
Lethargy	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0012 affected150 at risk
Paraesthesia	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Presyncope	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0012 affected150 at risk
Brain fog	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Disturbance in attention	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Hypoaesthesia	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Piriformis syndrome	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Somnolence	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Syncope	Nervous system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0008 affected150 at risk EG0017 affected150 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0008 affected150 at risk EG0015 affected150 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0005 affected150 at risk EG0012 affected150 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0004 affected150 at risk EG0013 affected150 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0013 affected150 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0010 affected150 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0005 affected150 at risk EG0014 affected150 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0004 affected150 at risk EG0012 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0013 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0012 affected150 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0012 affected150 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0013 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0012 affected150 at risk
Gingival pain	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Flatulence	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Food poisoning	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Gastritis	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Glossodynia	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Hyperaesthesia teeth	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Stomatitis	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Toothache	Gastrointestinal disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Fatigue	General disorders	MedDRA26.1	Systematic Assessment	EG0005 affected150 at risk EG0018 affected150 at risk
Injection site bruising	General disorders	MedDRA26.1	Systematic Assessment	EG0006 affected150 at risk EG0015 affected150 at risk
Influenza like illness	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0014 affected150 at risk
Pyrexia	General disorders	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0011 affected150 at risk
Injection site pain	General disorders	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0011 affected150 at risk
Vessel puncture site bruise	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Asthenia	General disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Chest discomfort	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Injection site pruritus	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Pain	General disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Thirst	General disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Vessel puncture site haematoma	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Vessel puncture site swelling	General disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
COVID-19	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0004 affected150 at risk EG0013 affected150 at risk
Rhinitis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0005 affected150 at risk EG0012 affected150 at risk
Nasopharyngitis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0015 affected150 at risk
Pharyngitis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0012 affected150 at risk
Balanitis candida	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Conjunctivitis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Folliculitis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Gastroenteritis	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Norovirus infection	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Otitis externa	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Tinea versicolour	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Tooth infection	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0004 affected150 at risk EG0017 affected150 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0016 affected150 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0014 affected150 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0012 affected150 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG00125 affected150 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0014 affected150 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0012 affected150 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0015 affected150 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0014 affected150 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0012 affected150 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0011 affected150 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0010 affected150 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Splinter	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
White blood cell count decreased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0017 affected150 at risk
Neutrophil count decreased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0014 affected150 at risk
Blood creatinine increased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0011 affected150 at risk
Platelet count decreased	Investigations	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0010 affected150 at risk
Alanine aminotransferase increased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Aspartate aminotransferase increased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Transaminases increased	Investigations	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0003 affected150 at risk EG0012 affected150 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0002 affected150 at risk EG0011 affected150 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Blepharitis	Eye disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Conjunctivitis allergic	Eye disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Diplopia	Eye disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Eye pain	Eye disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Ear pain	Ear and labyrinth disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Vertigo	Ear and labyrinth disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk
Gout	Metabolism and nutrition disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Seasonal allergy	Immune system disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Chromaturia	Renal and urinary disorders	MedDRA26.1	Systematic Assessment	EG0000 affected150 at risk EG0011 affected150 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA26.1	Systematic Assessment	EG0001 affected150 at risk EG0010 affected150 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BIIB800	Participants received a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.	0	150	2	150	75	150
EG001	Actemra	Participants received a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.	0	150	0	150	86	150

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Jaw fracture	Injury, poisoning and procedural complications	MedDRA26.1	Systematic Assessment		EG0001 affected150 at risk EG0010 affected150 at risk
Paresthesia	Nervous system disorders	MedDRA26.1	Systematic Assessment		EG0001 affected150 at risk EG0010 affected150 at risk