Trial Outcomes & Findings for Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (NCT NCT01457924)

NCT ID: NCT01457924

Last Updated: 2018-06-06

Results Overview

The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 232 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2018-06-06

Participant Flow

A participant (par.) completed the study if he/she completed all assessments up to and including the 24 Week Follow-up Phase (FUP) (Week 48) without prematurely discontinuing.

A total of 324 par. with Relapsing-Remitting Multiple Sclerosis (RRMS) were screened and 232 par. were randomized to 24 Week Treatment Phase (Weeks 0-12 were placebo controlled) of the study. A total of 231 par. received at least one dose of double-blind Investigational Product (IP) and were included in the Safety Population.

Participant milestones

Measure	Placebo/Ofatumumab 3 mg Par. received ofatumumab matching placebo subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 to Week 20, except on Week 12 participants received 3 milligrams (mg) ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 gram (g) and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w Par. received ofatumumab 3 mg SC injection every 12th week (q12w) on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Treatment Phase (Weeks 0-24) STARTED	67	34	32	34	64
Treatment Phase (Weeks 0-24) Completed to Week 12	65	31	30	33	60
Treatment Phase (Weeks 0-24) COMPLETED	64	29	30	33	58
Treatment Phase (Weeks 0-24) NOT COMPLETED	3	5	2	1	6
FUP (Weeks 24-48) STARTED	66	31	32	33	59
FUP (Weeks 24-48) COMPLETED	63	30	30	32	57
FUP (Weeks 24-48) NOT COMPLETED	3	1	2	1	2
Individualized FUP (Weeks 48+) STARTED	16	18	16	20	42
Individualized FUP (Weeks 48+) COMPLETED	11	14	12	15	36
Individualized FUP (Weeks 48+) NOT COMPLETED	5	4	4	5	6

Reasons for withdrawal

Measure	Placebo/Ofatumumab 3 mg Par. received ofatumumab matching placebo subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 to Week 20, except on Week 12 participants received 3 milligrams (mg) ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 gram (g) and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w Par. received ofatumumab 3 mg SC injection every 12th week (q12w) on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Treatment Phase (Weeks 0-24) Adverse Event	0	4	1	0	2
Treatment Phase (Weeks 0-24) Physician Decision	0	0	0	0	1
Treatment Phase (Weeks 0-24) Lack of Efficacy	1	0	0	0	0
Treatment Phase (Weeks 0-24) Protocol Violation	1	0	1	0	0
Treatment Phase (Weeks 0-24) Withdrawal by Subject	0	0	0	1	1
Treatment Phase (Weeks 0-24) Other-Protocol defined stopping criteria	1	1	0	0	2
FUP (Weeks 24-48) Adverse Event	0	0	1	0	0
FUP (Weeks 24-48) Physician Decision	1	0	1	0	0
FUP (Weeks 24-48) Lost to Follow-up	0	0	0	1	0
FUP (Weeks 24-48) Withdrawal by Subject	2	1	0	0	2
Individualized FUP (Weeks 48+) Lost to Follow-up	1	0	1	0	0
Individualized FUP (Weeks 48+) Other-Protocol defined stopping criteria	3	4	2	3	5
Individualized FUP (Weeks 48+) Withdrawal by Subject	1	0	1	2	1

Baseline Characteristics

Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis

Baseline characteristics by cohort

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=32 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=34 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=64 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Total n=231 Participants Total of all reporting groups
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	65 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants	61 Participants n=21 Participants	225 Participants n=10 Participants
Age, Continuous	37.7 Years STANDARD_DEVIATION 9.38 • n=5 Participants	38.1 Years STANDARD_DEVIATION 8.29 • n=7 Participants	37.2 Years STANDARD_DEVIATION 10.04 • n=5 Participants	37.3 Years STANDARD_DEVIATION 9.67 • n=4 Participants	36.2 Years STANDARD_DEVIATION 9.57 • n=21 Participants	37.2 Years STANDARD_DEVIATION 9.36 • n=10 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	22 Participants n=4 Participants	41 Participants n=21 Participants	155 Participants n=10 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	23 Participants n=21 Participants	76 Participants n=10 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Mixed Race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of IP and who had at least one post screen MRI assessment. Only those par. available at the specified time points were analyzed. Please see footnote of statistical analysis 1 for discrepancy in analysis population Week 24 and 48.

The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=33 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12	4.2 Cumulative number of lesions Standard Deviation 7.57	1.7 Cumulative number of lesions Standard Deviation 3.29	2.2 Cumulative number of lesions Standard Deviation 3.41	2.2 Cumulative number of lesions Standard Deviation 3.70	1.2 Cumulative number of lesions Standard Deviation 2.83

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=33 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of New GdE T1 Lesions at Week 24	5.6 Cumulative number of lesions Standard Deviation 9.34	2.2 Cumulative number of lesions Standard Deviation 3.80	2.5 Cumulative number of lesions Standard Deviation 3.88	2.2 Cumulative number of lesions Standard Deviation 3.83	1.4 Cumulative number of lesions Standard Deviation 3.04

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 24 and Week 48

Population: ITT Population. Only those par. available at the specified time points were analyzed.

Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=28 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=12 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=16 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=12 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=22 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Change From Baseline in Brain Volume at Week 24 and Week 48 Week 24	-13.5 Cubic centimeters Standard Deviation 26.96	-7.2 Cubic centimeters Standard Deviation 22.26	-8.4 Cubic centimeters Standard Deviation 26.62	-13.3 Cubic centimeters Standard Deviation 34.02	-1.4 Cubic centimeters Standard Deviation 56.42
Change From Baseline in Brain Volume at Week 24 and Week 48 Week 48	-22.0 Cubic centimeters Standard Deviation 38.22	-12.9 Cubic centimeters Standard Deviation 14.55	-5.0 Cubic centimeters Standard Deviation 28.84	-7.3 Cubic centimeters Standard Deviation 29.16	-11.8 Cubic centimeters Standard Deviation 55.30

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12	3.2 Number of lesions per scan Standard Deviation 7.41	1.2 Number of lesions per scan Standard Deviation 1.94	2.3 Number of lesions per scan Standard Deviation 3.94	1.8 Number of lesions per scan Standard Deviation 3.31	1.8 Number of lesions per scan Standard Deviation 4.81

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=33 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12	7.4 Cumulative number of lesions Standard Deviation 13.90	2.9 Cumulative number of lesions Standard Deviation 4.62	4.5 Cumulative number of lesions Standard Deviation 7.09	4.0 Cumulative number of lesions Standard Deviation 6.70	3.1 Cumulative number of lesions Standard Deviation 6.82

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12	607.5 Cubic millimeter (mm^3) Standard Deviation 1090.89	226.5 Cubic millimeter (mm^3) Standard Deviation 449.37	452.9 Cubic millimeter (mm^3) Standard Deviation 682.33	248.6 Cubic millimeter (mm^3) Standard Deviation 457.62	146.6 Cubic millimeter (mm^3) Standard Deviation 304.89

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=33 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12	1039.6 mm^3 Standard Deviation 1809.97	386.2 mm^3 Standard Deviation 628.41	886.2 mm^3 Standard Deviation 1637.47	426.5 mm^3 Standard Deviation 679.44	344.4 mm^3 Standard Deviation 735.57

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=33 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12	3.7 Cumulative number of lesions Standard Deviation 6.72	1.2 Cumulative number of lesions Standard Deviation 2.38	1.6 Cumulative number of lesions Standard Deviation 2.79	1.7 Cumulative number of lesions Standard Deviation 2.67	0.8 Cumulative number of lesions Standard Deviation 1.55

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population. Only those par. available at the specified time points were analyzed.

Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=30 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12	1204.5 mm^3 Standard Deviation 3426.79	279.9 mm^3 Standard Deviation 695.75	611.3 mm^3 Standard Deviation 1042.06	293.8 mm^3 Standard Deviation 576.35	167.9 mm^3 Standard Deviation 450.65

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: ITT Population. Only those par. available at the specified time points were analyzed.

The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=32 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48 Week 24	0.4 Number of lesions Standard Deviation 0.96	0.4 Number of lesions Standard Deviation 1.26	0.5 Number of lesions Standard Deviation 1.01	0.5 Number of lesions Standard Deviation 1.12	0.3 Number of lesions Standard Deviation 0.78
Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48 Week 48	0.6 Number of lesions Standard Deviation 1.27	0.5 Number of lesions Standard Deviation 1.26	0.5 Number of lesions Standard Deviation 0.98	0.6 Number of lesions Standard Deviation 1.25	0.3 Number of lesions Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: ITT Population. Only those par. available at the specified time points were analyzed.

Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant's last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.

Outcome measures

Measure	Placebo/Ofatumumab 3 mg n=67 Participants Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 Participants Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=32 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=33 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=63 Participants Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48 Week 24	86.9 mm^3 Standard Deviation 240.40	43.1 mm^3 Standard Deviation 131.96	67.4 mm^3 Standard Deviation 147.00	65.0 mm^3 Standard Deviation 139.14	42.9 mm^3 Standard Deviation 140.93
Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48 Week 48	113.6 mm^3 Standard Deviation 270.89	54.2 mm^3 Standard Deviation 137.74	63.2 mm^3 Standard Deviation 143.14	116.3 mm^3 Standard Deviation 370.35	53.2 mm^3 Standard Deviation 173.62

Adverse Events

Placebo/Ofatumumab 3 mg

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Ofatumumab 3 mg q12w

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Ofatumumab 30 mg q12w

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Ofatumumab 60 mg q12w

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Ofatumumab 60mg q4w

Serious events: 4 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo/Ofatumumab 3 mg n=67 participants at risk Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 participants at risk Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=32 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=34 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=64 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Hepatobiliary disorders Cholelithiasis	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Immune system disorders Cytokine release syndrome	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 2/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.

Other adverse events

Measure	Placebo/Ofatumumab 3 mg n=67 participants at risk Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 3 mg q12w n=34 participants at risk Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 30 mg q12w n=32 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60 mg q12w n=34 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.	Ofatumumab 60mg q4w n=64 participants at risk Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
Injury, poisoning and procedural complications Injection related reaction	26.9% 18/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	47.1% 16/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	40.6% 13/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	50.0% 17/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	65.6% 42/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 1/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 2/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Infections and infestations Nasopharyngitis	11.9% 8/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	12.5% 4/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	20.6% 7/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	10.9% 7/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Infections and infestations Urinary tract infection	6.0% 4/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	8.8% 3/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	9.4% 3/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Infections and infestations Respiratory tract infection	3.0% 2/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Nervous system disorders Headache	10.4% 7/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	9.4% 6/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Nervous system disorders Dizziness	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 1/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 4/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Nervous system disorders Neuralgia	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
General disorders Fatigue	11.9% 8/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	9.4% 3/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	4.7% 3/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
General disorders Pyrexia	3.0% 2/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
General disorders Injection site pain	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	9.0% 6/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 2/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Gastrointestinal disorders Nausea	6.0% 4/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 1/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 2/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	6.0% 4/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Investigations Reticulocyte count decreased	1.5% 1/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Investigations Blood immunoglobulin G decreased	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Investigations Weight decreased	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 2/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	3.1% 1/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Psychiatric disorders Anxiety	3.0% 2/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	6.2% 2/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Blood and lymphatic system disorders Anaemia	1.5% 1/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	2.9% 1/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/67 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	5.9% 2/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/32 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	0.00% 0/34 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.	1.6% 1/64 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24). SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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