A 52 Week Study To Assess The Use Of Bococizumab (PF-0495... | NCT01968980

ID	Type	Description	Link
2013-002644-87	EudraCT Number
SPIRE-HF	Other Identifier	Alias Study Number

A 52 Week Study To Assess The Use Of Bococizumab (PF-0495... | NCT01968980 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Bococizumab (PF-04950615;RN316)	Experimental	Bococizumab (PF-04950615;RN316)	Drug: Bococizumab (PF-04950615;RN316)
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Bococizumab (PF-04950615;RN316)	Drug	150 mg every 2 weeks, subcutaneous injection, 12 months	Bococizumab (PF-04950615;RN316)

Outcomes Module

Measure	Description	Time Frame
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Total Cholesterol (TC) at Week 12		Baseline, Week 12
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12		Baseline, Week 12

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
IMD Medical Group		Los Angeles	California	90020	United States
Hartford Hospital, JB704

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37994400	Derived	Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
37658997

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
FG001	PF--04950615

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Death		FG0000 subjects FG0011 subjects
Adverse Event		FG0001 subjects FG0013 subjects
Does not meet entry criteria		FG0001 subjects FG0013 subjects
Withdrawal by Subject		FG00013 subjects FG0015 subjects
Other unspecified		FG0001 subjects FG0012 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
BG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.7± 11.2 BG00156.5± 10.5 BG00256.1± 10.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00082 BG00173 BG002

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

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000175 OG001166

Title

Denominators

Categories

Title	Measurements
	OG000-0.3± 18.30 OG001-54.2± 29.34

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	LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	Mixed Model Repeated Measures (MMRM)		<0.001		Least square (LS) mean difference	-54.5	Standard Error of the Mean	2.54	2-Sided	95	-59.5	-49.5					Superiority or Other

Secondary

Percent Change From Baseline in Total Cholesterol (TC) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein (a) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

milligram per deciliter (mg/dL)

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Total Cholesterol (TC) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Lipoprotein (a) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

ratio

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

ratio

Baseline, Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Number

percentage of participants

Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.

Posted

Number

percentage of participants

Week 12, 24, 52

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.

Posted

Mean

Standard Deviation

microgram per milliliter

Week 12, 24, 52

ID	Title	Description
OG000	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000185

Secondary

Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.

Safety analysis set included all participants who received at least 1 dose of study treatment.

Posted

Number

participants

Baseline up to the end of study (up to 58 weeks)

ID	Title	Description
OG000	Placebo	Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
OG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Secondary

Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.

Analysis was performed on all participants who received at least 1 dose of PF-04950615.

Posted

Number

percentage of participants

Baseline up to the end of study (up to 58 weeks)

ID	Title	Description
OG000	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.

Units	Counts
Participants	OG000

Arm/Groups

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 matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.			22	185	36	185
EG001	PF--04950615	Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.			24	185	70	185

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0012 affected185 at risk
Angina pectoris	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0003 affected185 at risk EG0011 affected185 at risk
Angina unstable	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Myocardial infarction	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0011 affected185 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Retinal artery occlusion	Eye disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Chest discomfort	General disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Sudden cardiac death	General disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Vascular stent restenosis	General disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Appendicitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Bronchitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Diverticulitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Pyelonephritis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Wound sepsis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Obesity	Metabolism and nutrition disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Migraine	Nervous system disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Syncope	Nervous system disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0012 affected185 at risk
Depression	Psychiatric disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Psychotic disorder	Psychiatric disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Calculus bladder	Renal and urinary disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Renal colic	Renal and urinary disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Urinary retention	Renal and urinary disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA v19.0	Non-systematic Assessment	This is gender specific event. The number of participants evaluable for this event are 103 and 112.	EG0000 affected103 at risk EG0011 affected112 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v19.0	Non-systematic Assessment		EG0001 affected185 at risk EG0010 affected185 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk
Device breakage	Product Issues	MedDRA v19.0	Non-systematic Assessment		EG0000 affected185 at risk EG0011 affected185 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA v19.0	Non-systematic Assessment	EG0001 affected185 at risk EG00138 affected185 at risk
Influenza	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0006 affected185 at risk EG00110 affected185 at risk
Nasopharyngitis	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG00015 affected185 at risk EG00115 affected185 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v19.0	Non-systematic Assessment	EG0007 affected185 at risk EG00111 affected185 at risk
Headache	Nervous system disorders	MedDRA v19.0	Non-systematic Assessment	EG00010 affected185 at risk EG00110 affected185 at risk

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	MMRM		<0.001		LS mean difference	-37.6	Standard Error of the Mean	1.77	2-Sided	95	-41.1	-34.1					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	MMRM		<0.001		LS mean difference	-51.0	Standard Error of the Mean	2.36	2-Sided	95	-55.7	-46.4					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	MMRM		<0.001		LS mean difference	-48.0	Standard Error of the Mean	2.44	2-Sided	95	-52.8	-43.2					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	MMRM		<0.001		LS mean difference	-28.6	Standard Error of the Mean	2.73	2-Sided	95	-33.9	-23.2					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	MMRM		<0.001		LS mean difference	7.0	Standard Error of the Mean	1.47	2-Sided	95	4.1	9.9					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS mean difference	-52.1	Standard Error of the Mean	3.10	2-Sided	95	-58.2	-46.0					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS mean difference	-48.0	Standard Error of the Mean	2.87	2-Sided	95	-53.6	-42.3					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-35.8	Standard Error of the Mean	2.12	2-Sided	95	-40.0	-31.6					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-31.8	Standard Error of the Mean	2.02	2-Sided	95	-35.8	-27.8					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-48.5	Standard Error of the Mean	2.86	2-Sided	95	-54.1	-42.8					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-42.2	Standard Error of the Mean	2.71	2-Sided	95	-47.5	-36.9					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-46.8	Standard Error of the Mean	2.67	2-Sided	95	-52.1	-41.6					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-40.5	Standard Error of the Mean	2.53	2-Sided	95	-45.5	-35.5					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-35.1	Standard Error of the Mean	12.58	2-Sided	95	-59.8	-10.3					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-15.3	Standard Error of the Mean	5.58	2-Sided	95	-26.3	-4.4					Superiority or Other

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	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	5.9	Standard Error of the Mean	1.42	2-Sided	95	3.1	8.7					Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	2.9	Standard Error of the Mean	1.53	2-Sided	95	-0.1	5.9					Superiority or Other

Title

Denominators

Categories

Week 12 (n =175, 166)

Title	Measurements
	OG0007.1± 41.23 OG001-8.7± 38.07

Week 24 (n =176, 173)

Title	Measurements
	OG0007.6± 51.97 OG001-9.0± 40.01

Week 52 (n =169, 171)

Title	Measurements
	OG0004.9± 33.03 OG001-3.4± 58.27

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-17.0	Standard Error of the Mean	4.22	2-Sided	95	-25.3	-8.7	Superiority or Other
OG000 OG001	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-17.4	Standard Error of the Mean	4.90	2-Sided	95	-27.0	-7.8	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-9.5	Standard Error of the Mean	5.04	2-Sided	95	-19.4	0.4	Superiority or Other

Title

Denominators

Categories

Week 12 (n =175, 166)

Title	Measurements
	OG000-0.5± 11.70 OG0014.8± 12.15

Week 24 (n =176, 172)

Title	Measurements
	OG000-0.6± 10.69 OG0013.9± 10.72

Week 52 (n =169, 171)

Title	Measurements
	OG0000.3± 12.02 OG0013.0± 11.53

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	5.3	Standard Error of the Mean	1.25	2-Sided	95	2.9	7.8	Superiority or Other
OG000 OG001	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	4.6	Standard Error of the Mean	1.10	2-Sided	95	2.5	6.8	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	3.0	Standard Error of the Mean	1.22	2-Sided	95	0.5	5.4	Superiority or Other

Title

Denominators

Categories

Week 12 (n =175, 166)

Title	Measurements
	OG000-2.6± 13.34 OG001-1.6± 15.68

Week 24 (n =175, 170)

Title	Measurements
	OG000-2.8± 11.88 OG001-1.8± 13.45

Week 52 (n =167, 171)

Title	Measurements
	OG000-3.5± 11.90 OG001-2.4± 14.50

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	0.7	Standard Error of the Mean	1.50	2-Sided	95	-2.3	3.6	Superiority or Other
OG000 OG001	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	0.6	Standard Error of the Mean	1.31	2-Sided	95	-1.9	3.2	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	0.8	Standard Error of the Mean	1.39	2-Sided	95	-1.9	3.6	Superiority or Other

Title

Denominators

Categories

Week 12 (n =175, 166)

Title	Measurements
	OG0007.1± 41.23 OG001-8.7± 38.07

Week 24 (n =176, 173)

Title	Measurements
	OG0007.6± 51.97 OG001-9.0± 40.01

Week 52 (n =169, 171)

Title	Measurements
	OG0004.9± 33.03 OG001-3.4± 58.27

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-17.0	Standard Error of the Mean	4.22	2-Sided	95	-25.3	-8.7	Superiority or Other
OG000 OG001	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-17.4	Standard Error of the Mean	4.90	2-Sided	95	-27.0	-7.8	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-9.5	Standard Error of the Mean	5.04	2-Sided	95	-19.4	0.4	Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-78.8	Standard Error of the Mean	3.75	2-Sided	95	-86.2	-71.4					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-83.2	Standard Error of the Mean	4.15	2-Sided	95	-91.3	-75.0					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-87.0	Standard Error of the Mean	4.25	2-Sided	95	-95.4	-78.7					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-53.8	Standard Error of the Mean	2.71	2-Sided	95	-59.2	-48.5					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	-11.8	Standard Error of the Mean	1.47	2-Sided	95	-14.7	-8.9					Superiority or Other

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	LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.					LS Mean Difference	3.5	Standard Error of the Mean	0.75	2-Sided	95	2.0	4.9					Superiority or Other

Title

Denominators

Categories

Baseline (n =185, 185)

Title	Measurements
	OG0004.9± 1.81 OG0014.6± 1.32

Change at Week 12 (n =175, 166)

Title	Measurements
	OG0000.0± 1.00 OG001-1.8± 1.29

Change at Week 24 (n =174, 173)

Title	Measurements
	OG0000.0± 1.20 OG001-1.7± 1.29

Change at Week 52 (n =169, 171)

Title	Measurements
	OG000-0.0± 1.00 OG001-1.5± 1.35

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-2.0	Standard Error of the Mean	0.12	2-Sided	95	-2.2	-1.8	Superiority or Other
OG000 OG001	Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-1.8	Standard Error of the Mean	0.13	2-Sided	95	-2.1	-1.6	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-1.6	Standard Error of the Mean	0.12	2-Sided	95	-1.8	-1.3	Superiority or Other

Title

Denominators

Categories

Baseline (n =185, 185)

Title	Measurements
	OG0000.8± 0.31 OG0010.8± 0.23

Change at Week 12 (n =175, 166)

Title	Measurements
	OG0000.0± 0.18 OG001-0.4± 0.25

Change at Week 24 (n =176, 171)

Title	Measurements
	OG0000.0± 0.17 OG001-0.4± 0.25

Change at Week 52 (n =169, 171)

Title	Measurements
	OG0000.0± 0.17 OG001-0.3± 0.25

Group IDs	Group Description	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-0.4	Standard Error of the Mean	0.02	2-Sided	95	-0.5	-0.4	Superiority or Other
OG000 OG001	Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-0.4	Standard Error of the Mean	0.02	2-Sided	95	-0.4	-0.4	Superiority or Other
OG000 OG001	Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment groupvisit interaction, baseline value, baseline valuevisit interaction and geographical region.	LS Mean Difference	-0.3	Standard Error of the Mean	0.02	2-Sided	95	-0.4	-0.3	Superiority or Other

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	51.8	2-Sided	95	25.24	106.10	Superiority or Other
OG000 OG001	Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	66.9	2-Sided	95	30.32	147.43	Superiority or Other
OG000 OG001	Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	22.8	2-Sided	95	11.85	44.01	Superiority or Other

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	200.8	2-Sided	95	47.16	854.60	Superiority or Other
OG000 OG001	Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	228.0	2-Sided	95	51.95	1000.39	Superiority or Other
OG000 OG001	Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.	Odds Ratio (OR)	259.9	2-Sided	95	34.87	1937.06	Superiority or Other