Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Adult Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00611455

Enrollment

265

Registered

2008-02-11

Start date

2008-01-01

Completion date

2013-07-15

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

Detailed description

This study consists of a Double-blind , placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive ofatumumab (700mg x 2 infusions) or placebo ( saline x 2 infusions) in addition to their background methotrexate treatment. Patients who completed the 24 week Double-Blind period without receiving rescue DMARD treatment will be eligible to proceed into the 120 week Open-Label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity . Patients who have completed the Open-Label Period or have withdrawn will enter a maximum 2 year Follow-up Period, or until their Bcells return to normal or to baseline levels, whichever occurs earlier.

Interventions

DRUGofatumumab

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period

DRUGPlacebo

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years; * Active disease at the time of screening as defined by: ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR); * Inadequate response to previous or current methotrexate treatment; * Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion criteria

* Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA; * Previous exposure to biologic anti-rheumatic therapies, including investigational compounds; * Previous exposure to biologic DMARDs; Chronic or ongoing active infectious disease requiring systemic treatment; * Clinically significant cardiac disease; History of significant cerebrovascular disease; * Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease; * Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR; * Serum IgG \< lower limit of normal; * Breast feeding women or women with a positive pregnancy test at screening; * Current participation in any other interventional clinical study; * Patients known or suspected of not being able to comply with a study protocol.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24	Baseline and Week 24	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced \>=20% improvement from baseline in TJC and SJC and a \>=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Secondary

Measure	Time frame	Description
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Baseline and Weeks 4, 8, 12, 16, 20, and 24	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced \>=50% improvement from baseline in TJC and SJC and a \>=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Baseline and Weeks 4, 8, 12, 16, 20, and 24	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced \>=70% improvement from baseline in TJC and SJC and a \>=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Weeks 4, 8, 12, 16, 20, and 24	ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of \>=X% in tender/swollen joints (TJC/SJC), and an improvement of \>=X% in 3 of the 5 parameters (patient \[pt\] pain assessment, pt global assessment \[GA\], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Weeks 4, 8, 12, 16, 20, and 24	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Baseline and Weeks 4, 8, 12, 16, 20, and 24	The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Weeks 4, 8, 12, 16, 20, and 24	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Baseline and Weeks 4, 8, 12, 16, 20, and 24	The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Weeks 4, 8, 12, 16, 20, and 24	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \<=3.2 to \>5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=3.2 to \<=5.1); non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1.
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Weeks 4, 8, 12, 16, 20, and 24	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \<=3.2 to \>5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=3.2 to \<=5.1); non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1.
Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)	Week 24	The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of \>=0.22.
Number of Participants With Clinical Remission at Week 24	Week 24	Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) \<2.6 at Week 24.
Change From Baseline in Tender Joint Count at Week 24	Baseline and Week 24	Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.
Change From Baseline in Swollen Joint Count at Week 24	Baseline and Week 24	Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.
Change From Baseline in the Participant-assessed Pain Score at Week 24	Baseline and Week 24	A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value.
Change From Baseline in Participant-assessed Global Disease Score at Week 24	Baseline and Week 24	The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value.
Change From Baseline in the Physician-assessed Global Disease Score at Week 24	Baseline and Week 24	The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value.
Change From Baseline in HAQ-DI Score at Week 24	Baseline and Week 24	The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.
Change From Baseline in CRP at Week 24	Baseline and Week 24	Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.
Change From Baseline in ESR at Week 24	Baseline and Week 24	ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Baseline and Week 24	The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 \[poorer health\] to 100 \[better health\]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Baseline and Week 24	The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 \[poorer health\] to 100 \[better health\]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24	Baseline and Week 24	The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued.
Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	Baseline and Week 24	The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.
Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24	Baseline and Week 24	The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 \<=3.2, moderate if 3.2\< DAS28 \<=5.1, or high if DAS28 \> 5.1. A DAS28 \<2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 \<=3.2, moderate if 3.2\< DAS28 \<=5.1, or high if DAS28 \> 5.1. A DAS28 \<2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. Remission is defined as a DAS28 score \<2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score \>=2.6 and \<3.2 at any time during the first 24 weeks of each treatment course.
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	First 24 weeks of each treatment course (assessed up to Week 144)	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. Remission is defined as a DAS28 score \<2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score \>=2.6 and \<3.2 at any time during the first 24 weeks of each treatment course.
Time to Retreatment, by Ofatumumab Treatment Course	From Baseline up to Week 144	Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144	An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=2%) and SAEs.
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury \[mmHg\]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144	The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	From baseline up to Week 144	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low \[relative to lower limit of normal\], CC High \[relative to upper limit of normal\]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	From baseline up to Week 144	Only those parameters for a particular flag (\<LLN or \>ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):\<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):\<0.31ng/L and Serum amyloid A: \<1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: \>6 units; RF-IgG:\>6 units; RF-IgM:\>6 units; Anti-CCP:\>19.9999 units; B-ls:\>1343.3 ng/L; IL-6: \>5 ng/L; RF:\>11.9999 kilounits (KU)/L; Serum amyloid A:\>82432 ng/mL.
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Baseline and Weeks 4, 8, 12, 16, and 20	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced \>=20% improvement from baseline in TJC and SJC and a \>=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)	The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.
Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab	From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)	Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.
Number of Participants With a Positive JC Virus Test Result During the Follow-up Period	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)	Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low \[relative to lower limit of normal\], CC High \[relative to upper limit of normal\]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.
Number of Participants With Any Serious Adverse Event During the Follow-up Period	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])	A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.

Countries

Argentina, Australia, Belgium, Chile, Czechia, Hungary, Peru, Poland, Romania, Russia, South Africa, Spain, United Kingdom

Participant flow

Pre-assignment details

Study OFA110635 was comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who completed the OL Period, or who were withdrawn, entered a Follow-up (FU) period (approximately 2 years).

Participants by arm

Arm	Count
Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	131
Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	129
Total	260

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
DB Treatment Period (24 Weeks)	Adverse Event	2	8	0
DB Treatment Period (24 Weeks)	Lack of Efficacy	2	0	0
DB Treatment Period (24 Weeks)	Protocol Violation	4	1	0
DB Treatment Period (24 Weeks)	Randomized, but Not Treated	1	0	0
DB Treatment Period (24 Weeks)	Randomized in Error; Not Treated	2	2	0
DB Treatment Period (24 Weeks)	Withdrawal by Subject	2	3	0
Follow-up Period (Approximately 2 Years)	Adverse Event	0	0	30
Follow-up Period (Approximately 2 Years)	Lack of Efficacy	0	0	12
Follow-up Period (Approximately 2 Years)	Lost to Follow-up	0	0	13
Follow-up Period (Approximately 2 Years)	Protocol-defined Stopping Criteria Met	0	0	23
Follow-up Period (Approximately 2 Years)	Protocol Violation	0	0	4
Follow-up Period (Approximately 2 Years)	Study Closed/Terminated	0	0	80
Follow-up Period (Approximately 2 Years)	Withdrawal by Subject	0	0	49
OL Treatment Period (120 Weeks)	Adverse Event	0	17	0
OL Treatment Period (120 Weeks)	Lack of Efficacy	0	9	0
OL Treatment Period (120 Weeks)	Lost to Follow-up	0	5	0
OL Treatment Period (120 Weeks)	Physician Decision	0	5	0
OL Treatment Period (120 Weeks)	Protocol-defined Stopping Criteria Met	0	12	0
OL Treatment Period (120 Weeks)	Protocol Violation	0	3	0
OL Treatment Period (120 Weeks)	Study Closed/Terminated	0	110	0
OL Treatment Period (120 Weeks)	Withdrawal by Subject	0	18	0

Baseline characteristics

Characteristic	Ofatumumab 700 mg	Total	Placebo
Age, Continuous	51.7 Years STANDARD_DEVIATION 11.24	52.7 Years STANDARD_DEVIATION 11.39	53.6 Years STANDARD_DEVIATION 11.5
Race/Ethnicity, Customized Hispanic/Latino	51 participants	103 participants	52 participants
Race/Ethnicity, Customized Not Hispanic/Latino	78 participants	157 participants	79 participants
Sex: Female, Male Female	106 Participants	214 Participants	108 Participants
Sex: Female, Male Male	23 Participants	46 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	46 / 130	226 / 243	0 / 224
serious Total, serious adverse events	4 / 130	44 / 243	13 / 224

Outcome results

Primary

Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced \>=20% improvement from baseline in TJC and SJC and a \>=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Time frame: Baseline and Week 24

Population: Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.

Arm	Measure	Value (NUMBER)
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24	35 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24	64 participants

p-value: <0.00195% CI: [1.67, 4.91]Cochran-Mantel-Haenszel

Secondary

Change From Baseline in CRP at Week 24

Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in CRP at Week 24	-0.10 milligrams per liter (mg/L)
Ofatumumab 700 mg	Change From Baseline in CRP at Week 24	-4.85 milligrams per liter (mg/L)

Secondary

Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant

The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, n=130, 126	-0.65 scores on a scale	Standard Deviation 1.218
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, n=130, 126	-0.97 scores on a scale	Standard Deviation 1.221
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, n=130, 126	-0.85 scores on a scale	Standard Deviation 1.194
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, n=129, 124	-0.84 scores on a scale	Standard Deviation 1.053
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, n=130, 126	-0.85 scores on a scale	Standard Deviation 1.215
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, n=130, 126	-0.88 scores on a scale	Standard Deviation 0.992
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, n=130, 126	-1.70 scores on a scale	Standard Deviation 1.262
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, n=130, 126	-1.41 scores on a scale	Standard Deviation 1.112
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, n=129, 124	-1.09 scores on a scale	Standard Deviation 0.886
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, n=130, 126	-1.69 scores on a scale	Standard Deviation 1.255
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, n=130, 126	-1.72 scores on a scale	Standard Deviation 1.166
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, n=130, 126	-1.71 scores on a scale	Standard Deviation 1.201

Secondary

Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, n=129, 124	-0.92 scores on a scale	Standard Deviation 1.106
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, n=130, 126	-0.97 scores on a scale	Standard Deviation 1.048
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, n=130, 126	-1.10 scores on a scale	Standard Deviation 1.211
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, n=130, 126	-0.97 scores on a scale	Standard Deviation 1.183
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, n=130, 126	-0.99 scores on a scale	Standard Deviation 1.175
Placebo	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, n=130, 126	-0.73 scores on a scale	Standard Deviation 1.203
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, n=130, 126	-1.83 scores on a scale	Standard Deviation 1.304
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, n=129, 124	-1.08 scores on a scale	Standard Deviation 0.891
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, n=130, 126	-1.79 scores on a scale	Standard Deviation 1.189
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, n=130, 126	-1.46 scores on a scale	Standard Deviation 1.092
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, n=130, 126	-1.76 scores on a scale	Standard Deviation 1.264
Ofatumumab 700 mg	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, n=130, 126	-1.77 scores on a scale	Standard Deviation 1.257

Secondary

Change From Baseline in ESR at Week 24

ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in ESR at Week 24	-5 millimeters per hour (mm/hr)
Ofatumumab 700 mg	Change From Baseline in ESR at Week 24	-15 millimeters per hour (mm/hr)

Secondary

Change From Baseline in HAQ-DI Score at Week 24

The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in HAQ-DI Score at Week 24	-0.25 scores on a scale
Ofatumumab 700 mg	Change From Baseline in HAQ-DI Score at Week 24	-0.38 scores on a scale

Secondary

Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24

The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	Anti-CCP, n=120, 115	0.0 Units/Liter
Placebo	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgA, n=119, 110	0.0 Units/Liter
Placebo	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgG, n=119, 110	0.0 Units/Liter
Placebo	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgM, n=119, 110	0.0 Units/Liter
Ofatumumab 700 mg	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgM, n=119, 110	-6.3 Units/Liter
Ofatumumab 700 mg	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	Anti-CCP, n=120, 115	-138.0 Units/Liter
Ofatumumab 700 mg	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgG, n=119, 110	-4.8 Units/Liter
Ofatumumab 700 mg	Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24	RF-IgA, n=119, 110	-3 Units/Liter

Secondary

Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24

The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24	IL-6, n=119, 115	-0.410 nanogram per liter (ng/l)
Placebo	Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24	Serum Amyloid A, n=120, 114	-10850.5 nanogram per liter (ng/l)
Ofatumumab 700 mg	Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24	IL-6, n=119, 115	-4.040 nanogram per liter (ng/l)
Ofatumumab 700 mg	Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24	Serum Amyloid A, n=120, 114	-53513.5 nanogram per liter (ng/l)

Secondary

Change From Baseline in Participant-assessed Global Disease Score at Week 24

The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in Participant-assessed Global Disease Score at Week 24	-6.0 scores on a scale
Ofatumumab 700 mg	Change From Baseline in Participant-assessed Global Disease Score at Week 24	-16.5 scores on a scale

Secondary

Change From Baseline in Swollen Joint Count at Week 24

Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in Swollen Joint Count at Week 24	-4.50 number of swollen joints
Ofatumumab 700 mg	Change From Baseline in Swollen Joint Count at Week 24	-8.00 number of swollen joints

Secondary

Change From Baseline in Tender Joint Count at Week 24

Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in Tender Joint Count at Week 24	-5 number of tender joints
Ofatumumab 700 mg	Change From Baseline in Tender Joint Count at Week 24	-12 number of tender joints

Secondary

Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24

The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24	2 scores on a scale
Ofatumumab 700 mg	Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24	6 scores on a scale

Secondary

Change From Baseline in the Participant-assessed Pain Score at Week 24

A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in the Participant-assessed Pain Score at Week 24	-5 scores on a scale
Ofatumumab 700 mg	Change From Baseline in the Participant-assessed Pain Score at Week 24	-22 scores on a scale

Secondary

Change From Baseline in the Physician-assessed Global Disease Score at Week 24

The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (MEDIAN)
Placebo	Change From Baseline in the Physician-assessed Global Disease Score at Week 24	-9.50 scores on a scale
Ofatumumab 700 mg	Change From Baseline in the Physician-assessed Global Disease Score at Week 24	-20.50 scores on a scale

Secondary

Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24

The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 \[poorer health\] to 100 \[better health\]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Social Functioning	3.56 scores on a scale	Standard Error 1.361
Placebo	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Mental Component Summary	1.57 scores on a scale	Standard Error 1.308
Placebo	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Role Emotional	2.23 scores on a scale	Standard Error 1.612
Placebo	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Mental Health	2.92 scores on a scale	Standard Error 1.278
Placebo	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Vitality	2.46 scores on a scale	Standard Error 1.169
Ofatumumab 700 mg	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Mental Health	5.40 scores on a scale	Standard Error 1.249
Ofatumumab 700 mg	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Role Emotional	4.93 scores on a scale	Standard Error 1.563
Ofatumumab 700 mg	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Mental Component Summary	4.60 scores on a scale	Standard Error 1.272
Ofatumumab 700 mg	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Social Functioning	4.98 scores on a scale	Standard Error 1.331
Ofatumumab 700 mg	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24	Vitality	7.26 scores on a scale	Standard Error 1.154

Secondary

Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24

Time frame: Baseline and Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Physical Functioning	3.14 scores on a scale	Standard Error 1.125
Placebo	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Bodily Pain	3.63 scores on a scale	Standard Error 1.197
Placebo	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Role Physical	5.43 scores on a scale	Standard Error 1.259
Placebo	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	General Health	2.28 scores on a scale	Standard Error 1.033
Placebo	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Physical Component Summary	4.21 scores on a scale	Standard Error 1.048
Ofatumumab 700 mg	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	General Health	4.08 scores on a scale	Standard Error 1.011
Ofatumumab 700 mg	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Physical Component Summary	6.69 scores on a scale	Standard Error 1.031
Ofatumumab 700 mg	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Physical Functioning	5.70 scores on a scale	Standard Error 1.1
Ofatumumab 700 mg	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Role Physical	6.64 scores on a scale	Standard Error 1.231
Ofatumumab 700 mg	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24	Bodily Pain	8.28 scores on a scale	Standard Error 1.17

Secondary

Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant

The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 12, n=130, 126	5.31 scores on a scale	Standard Deviation 1.349
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 20, n=130, 126	5.41 scores on a scale	Standard Deviation 1.414
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 4, n=129, 124	5.48 scores on a scale	Standard Deviation 1.332
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 8, n=130, 126	5.43 scores on a scale	Standard Deviation 1.289
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 16, n=130, 126	5.43 scores on a scale	Standard Deviation 1.329
Placebo	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 24, n=130, 126	5.67 scores on a scale	Standard Deviation 1.439
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 8, n=130, 126	5.14 scores on a scale	Standard Deviation 1.276
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 12, n=130, 126	4.83 scores on a scale	Standard Deviation 1.358
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 24, n=130, 126	4.84 scores on a scale	Standard Deviation 1.36
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 20, n=130, 126	4.77 scores on a scale	Standard Deviation 1.427
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 4, n=129, 124	5.51 scores on a scale	Standard Deviation 1.127
Ofatumumab 700 mg	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant	Week 16, n=130, 126	4.81 scores on a scale	Standard Deviation 1.31

Secondary

Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 4, n=129, 124	4.78 scores on a scale	Standard Deviation 1.241
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 8, n=130, 126	4.75 scores on a scale	Standard Deviation 1.205
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 12, n=130, 126	4.66 scores on a scale	Standard Deviation 1.333
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 16, n=130, 126	4.78 scores on a scale	Standard Deviation 1.327
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 20, n=130, 126	4.78 scores on a scale	Standard Deviation 1.387
Placebo	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 24, n=130, 126	4.98 scores on a scale	Standard Deviation 1.437
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 20, n=130, 126	4.13 scores on a scale	Standard Deviation 1.395
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 4, n=129, 124	4.74 scores on a scale	Standard Deviation 1.099
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 16, n=130, 126	4.11 scores on a scale	Standard Deviation 1.296
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 8, n=130, 126	4.41 scores on a scale	Standard Deviation 1.285
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 24, n=130, 126	4.12 scores on a scale	Standard Deviation 1.27
Ofatumumab 700 mg	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)	Week 12, n=130, 126	4.14 scores on a scale	Standard Deviation 1.367

Secondary

Median ACRn at Weeks 4, 8, 12, 16, 20, and 24

ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of \>=X% in tender/swollen joints (TJC/SJC), and an improvement of \>=X% in 3 of the 5 parameters (patient \[pt\] pain assessment, pt global assessment \[GA\], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 4, n=129, 124	6.0 percent change
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 8, n=130, 126	5.5 percent change
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 12, n=130, 126	0.5 percent change
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 16, n=130, 126	0.0 percent change
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 20, n=130, 126	4.0 percent change
Placebo	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 24, n=130, 126	-2.5 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 20, n=130, 126	21.0 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 4, n=129, 124	13.0 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 16, n=130, 126	26.0 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 8, n=130, 126	22.0 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 24, n=130, 126	21.0 percent change
Ofatumumab 700 mg	Median ACRn at Weeks 4, 8, 12, 16, 20, and 24	Week 12, n=130, 126	25.0 percent change

Secondary

Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course

The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 \<=3.2, moderate if 3.2\< DAS28 \<=5.1, or high if DAS28 \> 5.1. A DAS28 \<2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, n=0, 237, 0	-2.15 scores on a scale	Standard Deviation 1.166
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, n=0, 193, 0	-1.55 scores on a scale	Standard Deviation 1.02
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, n=0, 125, 0	-1.67 scores on a scale	Standard Deviation 1.144
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, n=0, 69, 0	-1.40 scores on a scale	Standard Deviation 1.081
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, n=0, 31, 0	-1.61 scores on a scale	Standard Deviation 1.036
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, n=0, 11, 0	-1.33 scores on a scale	Standard Deviation 0.71
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, n=0, 2, 0	-0.05 scores on a scale	Standard Deviation 0.2

Secondary

Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course

The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 \<=3.2, moderate if 3.2\< DAS28 \<=5.1, or high if DAS28 \> 5.1. A DAS28 \<2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, n=0, 238, 0	-2.32 scores on a scale	Standard Deviation 1.192
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, n=0, 194, 0	-1.77 scores on a scale	Standard Deviation 1.072
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, n=0, 129, 0	-1.77 scores on a scale	Standard Deviation 1.203
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, n=0, 69, 0	-1.47 scores on a scale	Standard Deviation 1.065
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, n=0, 31, 0	-1.77 scores on a scale	Standard Deviation 1.015
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, n=0, 11, 0	-1.45 scores on a scale	Standard Deviation 0.845
Ofatumumab 700 mg	Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, n=0, 2, 0	-0.07 scores on a scale	Standard Deviation 0.696

Secondary

Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, n=0, 243, 0	3.43 scores on a scale	Standard Deviation 1.321
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, n=0, 198, 0	3.09 scores on a scale	Standard Deviation 1.142
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, n=0, 136, 0	2.86 scores on a scale	Standard Deviation 1.156
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, n=0, 72, 0	2.94 scores on a scale	Standard Deviation 1.161
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, n=0, 31, 0	2.90 scores on a scale	Standard Deviation 1.362
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, n=0, 11, 0	3.39 scores on a scale	Standard Deviation 1.401
Ofatumumab 700 mg	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, n=0, 2, 0	4.55 scores on a scale	Standard Deviation 1.003

Secondary

Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 1, n=0, 243, 0	4.01 Scores on a scale	Standard Deviation 1.396
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 2, n=0, 198, 0	3.59 Scores on a scale	Standard Deviation 1.227
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 3, n=0, 136, 0	3.36 Scores on a scale	Standard Deviation 1.225
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 4, n=0, 72, 0	3.50 Scores on a scale	Standard Deviation 1.175
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 5, n=0, 31, 0	3.34 Scores on a scale	Standard Deviation 1.326
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 6, n=0, 11, 0	3.82 Scores on a scale	Standard Deviation 1.588
Ofatumumab 700 mg	Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course	TC 7, n=0, 2, 0	5.34 Scores on a scale	Standard Deviation 1.038

Secondary

Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)

The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of \>=0.22.

Time frame: Week 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Value (NUMBER)
Placebo	Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)	59 participants
Ofatumumab 700 mg	Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)	74 participants

Secondary

Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. Remission is defined as a DAS28 score \<2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score \>=2.6 and \<3.2 at any time during the first 24 weeks of each treatment course.

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Remission, n=0, 136, 0	63 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Remission, n=0, 243, 0	71 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Low Disease Activity, n=0, 243, 0	44 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Remission, n=0, 198, 0	71 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Low Disease Activity, n=0, 198, 0	36 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Low Disease Activity, n=0, 136, 0	21 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Remission, n=0, 72, 0	30 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Low Disease Activity, n=0, 72, 0	11 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Remission,n=0, 31, 0	14 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Low Disease Activity,n=0, 31, 0	4 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Remission,n=0, 11, 0	4 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Low Disease Activity,n=0, 11, 0	2 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Remission, n=0, 2, 0	0 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Low Disease Activity, n=0, 2, 0	0 participants

Secondary

Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28\<=3.2), moderate (3.2\<DAS28\<=5.1), or high (DAS28\>5.1); total score, 0-9.4. A DAS28 \<2.6 corresponds to remission. Remission is defined as a DAS28 score \<2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score \>=2.6 and \<3.2 at any time during the first 24 weeks of each treatment course.

Time frame: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Remission, n=0, 243, 0	38 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Low Disease Activity, n=0, 243, 0	33 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Remission, n=0, 198, 0	47 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Low Disease Activity, n=0, 198, 0	33 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Remission, n=0, 136, 0	40 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Low Disease Activity, n=0, 136, 0	31 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Remission, n=0, 72, 0	15 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Low Disease Activity, n=0, 72, 0	20 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Remission, n=0, 31, 0	13 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Low Disease Activity, n=0, 31, 0	4 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Remission, n=0, 11, 0	3 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Low Disease Activity, n=0, 11, 0	1 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Remission, n=0, 2, 0	0 participants
Ofatumumab 700 mg	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Low Disease Activity, n=0, 2, 0	0 participants

Secondary

Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20

Time frame: Baseline and Weeks 4, 8, 12, 16, and 20

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 12	44 participants
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 16	38 participants
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 8	43 participants
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 20	40 participants
Placebo	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 4	42 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 20	62 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 12	71 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 4	52 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 8	66 participants
Ofatumumab 700 mg	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20	Week 16	67 participants

Secondary

Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced \>=50% improvement from baseline in TJC and SJC and a \>=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 4	13 participants
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 8	12 participants
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 12	14 participants
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 16	13 participants
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 20	19 participants
Placebo	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 24	14 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 20	31 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 4	14 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 16	37 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 8	23 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 24	35 participants
Ofatumumab 700 mg	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24	Week 12	36 participants

Secondary

Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced \>=70% improvement from baseline in TJC and SJC and a \>=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 4	6 participants
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 12	6 participants
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 24	3 participants
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 8	3 participants
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 20	6 participants
Placebo	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 16	5 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 24	17 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 20	18 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 4	4 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 8	10 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 12	19 participants
Ofatumumab 700 mg	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24	Week 16	18 participants

Secondary

Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 40, n=0, 59, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 24, n=0, 150, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 32, n=0, 97, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 56, n=0, 43, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 32, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 8, n=0, 237, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 16, n=0, 182, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 24, n=0, 177, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 32, n=0, 96, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 48, n=0, 46, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 56, n=0, 31, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 64, n=0, 23, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 72, n=0, 19, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 80, n=0, 15, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 88, n=0, 13, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 96, n=0, 12, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 104, n=0, 10, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 112, n=0, 8, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 120, n=0, 7, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 128, n=0, 4, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 136, n=0, 4, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 144, n=0, 4, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 8, n=0, 194, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 16, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 40, n=0, 69, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 48, n=0, 58, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 64, n=0, 31, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 72, n=0, 24, 0	11 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 80, n=0, 21, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 88, n=0, 16, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 96, n=0, 10, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 104, n=0, 8, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 112, n=0, 4, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 120, n=0, 3, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 128, n=0, 1, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 8, n=0, 132, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 16, n=0, 119, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 24, n=0, 92, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 32, n=0, 63, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 40, n=0, 35, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 48, n=0, 24, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 56, n=0, 14, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 64, n=0, 10, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 72, n=0, 8, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 80, n=0, 8, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 88, n=0, 4, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 96, n=0, 2, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 104, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 8, n=0, 70, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 16, n=0, 53, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 24, n=0, 37, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 32, n=0, 25, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 40, n=0, 8, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 48, n=0, 2, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 8, n=0, 30, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 16, n=0, 20, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 24, n=0, 20, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 32, n=0, 9, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 40, n=0, 3, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 8, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 16, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 24, n=0, 7, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 8, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 16, n=0, 1, 0	0 Participants

Secondary

Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 16, n=0, 182, 0	156 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 24, n=0, 177, 0	152 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 64, n=0, 31, 0	28 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 128, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 24, n=0, 92, 0	81 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 32, n=0, 63, 0	57 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 40, n=0, 35, 0	32 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 48, n=0, 24, 0	21 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 8, n=0, 237, 0	197 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 32, n=0, 96, 0	88 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 40, n=0, 59, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 48, n=0, 46, 0	40 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 56, n=0, 31, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 64, n=0, 23, 0	18 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 72, n=0, 19, 0	16 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 80, n=0, 15, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 88, n=0, 13, 0	11 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 96, n=0, 12, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 104, n=0, 10, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 112, n=0, 8, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 120, n=0, 7, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 128, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 136, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 144, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 8, n=0, 194, 0	170 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 16, n=0, 177, 0	155 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 24, n=0, 150, 0	128 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 32, n=0, 97, 0	82 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 40, n=0, 69, 0	60 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 48, n=0, 58, 0	48 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 56, n=0, 43, 0	35 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 72, n=0, 24, 0	20 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 80, n=0, 21, 0	17 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 88, n=0, 16, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 96, n=0, 10, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 104, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 112, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 120, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 8, n=0, 132, 0	118 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 16, n=0, 119, 0	105 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 56, n=0, 14, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 64, n=0, 10, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 72, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 80, n=0, 8, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 88, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 96, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 104, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 8, n=0, 70, 0	66 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 16, n=0, 53, 0	49 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 24, n=0, 37, 0	34 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 32, n=0, 25, 0	23 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 40, n=0, 8, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 48, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 8, n=0, 30, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 16, n=0, 27, 0	24 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 24, n=0, 20, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 32, n=0, 9, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 40, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 8, n=0, 11, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 16, n=0, 10, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 24, n=0, 7, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 32, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 8, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 16, n=0, 1, 0	1 Participants

Secondary

Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 96, n=0, 10, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 24, n=0, 92, 0	81 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 32, n=0, 63, 0	58 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 8, n=0, 237, 0	209 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 16, n=0, 182, 0	163 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 24, n=0, 177, 0	150 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 32, n=0, 96, 0	89 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 40, n=0, 59, 0	50 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 48, n=0, 46, 0	40 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 56, n=0, 31, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 64, n=0, 23, 0	18 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 72, n=0, 19, 0	16 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 80, n=0, 15, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 88, n=0, 13, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 96, n=0, 12, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 104, n=0, 10, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 112, n=0, 8, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 120, n=0, 7, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 128, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 136, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 144, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 8, n=0, 194, 0	174 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 16, n=0, 177, 0	162 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 24, n=0, 150, 0	136 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 32, n=0, 97, 0	85 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 40, n=0, 69, 0	63 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 48, n=0, 58, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 56, n=0, 43, 0	37 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 64, n=0, 31, 0	29 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 72, n=0, 24, 0	22 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 80, n=0, 21, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 88, n=0, 16, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 104, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 112, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 120, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 128, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 8, n=0, 132, 0	120 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 16, n=0, 119, 0	108 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 40, n=0, 35, 0	33 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 48, n=0, 24, 0	20 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 56, n=0, 14, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 64, n=0, 10, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 72, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 80, n=0, 8, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 88, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 96, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 104, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 8, n=0, 70, 0	68 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 16, n=0, 53, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 24, n=0, 37, 0	35 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 32, n=0, 25, 0	24 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 40, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 48, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 8, n=0, 30, 0	27 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 16, n=0, 27, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 24, n=0, 20, 0	18 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 32, n=0, 9, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 40, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 8, n=0, 11, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 16, n=0, 10, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 24, n=0, 7, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 32, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 8, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 16, n=0, 1, 0	1 Participants

Secondary

Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga \[10\^9\] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 16, n=0, 182, 0	166 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 24, n=0, 177, 0	160 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 32, n=0, 96, 0	90 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 40, n=0, 59, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 88, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 96, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 40, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 8, n=0, 237, 0	216 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 48, n=0, 46, 0	42 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 56, n=0, 31, 0	29 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 64, n=0, 23, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 72, n=0, 19, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 80, n=0, 15, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 88, n=0, 13, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 96, n=0, 12, 0	11 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 104, n=0, 10, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 112, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 120, n=0, 7, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 128, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 136, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 1, Week 144, n=0, 4, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 8, n=0, 194, 0	181 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 16, n=0, 177, 0	164 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 24, n=0, 150, 0	140 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 32, n=0, 97, 0	91 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 40, n=0, 69, 0	65 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 48, n=0, 58, 0	54 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 56, n=0, 43, 0	40 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 64, n=0, 31, 0	29 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 72, n=0, 24, 0	23 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 80, n=0, 21, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 88, n=0, 16, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 96, n=0, 10, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 104, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 112, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 120, n=0, 3, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 2, Week 128, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 8, n=0, 132, 0	128 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 16, n=0, 119, 0	113 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 24, n=0, 92, 0	88 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 32, n=0, 63, 0	61 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 40, n=0, 35, 0	34 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 48, n=0, 24, 0	24 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 56, n=0, 14, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 64, n=0, 10, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 72, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 80, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 3, Week 104, n=0, 1, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 8, n=0, 70, 0	68 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 16, n=0, 53, 0	52 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 24, n=0, 37, 0	37 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 32, n=0, 25, 0	24 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 40, n=0, 8, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 4, Week 48, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 8, n=0, 30, 0	28 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 16, n=0, 27, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 24, n=0, 20, 0	20 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 5, Week 32, n=0, 9, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 8, n=0, 11, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 16, n=0, 10, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 24, n=0, 7, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 6, Week 32, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 8, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course	TC 7, Week 16, n=0, 1, 0	1 Participants

Secondary

Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=2%) and SAEs.

Time frame: First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144

Population: AT Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 7, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 1, n=0, 243, 0	212 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 2, n=0, 198, 0	151 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 3, n=0, 136, 0	91 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 4, n=0, 72, 0	43 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 5, n=0, 31, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any AE, TC 6, n=0, 11, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 1, n=0, 243, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 2, n=0, 198, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 3, n=0, 136, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 4, n=0, 72, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 5, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 6, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course	Any SAE, TC 7, n=0, 2, 0	0 Participants

Secondary

Number of Participants With Any Serious Adverse Event During the Follow-up Period

A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.

Time frame: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])

Population: Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.

Arm	Measure	Value (NUMBER)
Placebo or OFA 700 mg: FU Period	Number of Participants With Any Serious Adverse Event During the Follow-up Period	13 Participants

Secondary

Number of Participants With a Positive JC Virus Test Result During the Follow-up Period

Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.

Time frame: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Value (NUMBER)
Placebo or OFA 700 mg: FU Period	Number of Participants With a Positive JC Virus Test Result During the Follow-up Period	8 Participants

Secondary

Number of Participants With Clinical Remission at Week 24

Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) \<2.6 at Week 24.

Time frame: Week 24

Population: ITT Population

Arm	Measure	Value (NUMBER)
Placebo	Number of Participants With Clinical Remission at Week 24	7 participants
Ofatumumab 700 mg	Number of Participants With Clinical Remission at Week 24	13 participants

Secondary

Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period

The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.

Time frame: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgA <LLN	1 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgA >ULN	29 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgG <LLN	16 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgG >ULN	20 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgM <LLN	35 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period	IgM >ULN	7 Participants

Secondary

Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)

Only those parameters for a particular flag (\<LLN or \>ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):\<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):\<0.31ng/L and Serum amyloid A: \<1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: \>6 units; RF-IgG:\>6 units; RF-IgM:\>6 units; Anti-CCP:\>19.9999 units; B-ls:\>1343.3 ng/L; IL-6: \>5 ng/L; RF:\>11.9999 kilounits (KU)/L; Serum amyloid A:\>82432 ng/mL.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 2, PBL, >ULN, n=0, 23, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 2, BL, >ULN, n=0, 52, 0	18 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 2, PBL, >ULN, n=0, 24, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 3, BL, >ULN, n=0, 20, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 3, PBL, >ULN, n=0, 95, 0	42 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 3, BL, >ULN, n=0, 20, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 3, PBL, >ULN, n=0, 95, 0	21 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 3, BL, >ULN, n=0, 20, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 3, PBL, >ULN, n=0, 95, 0	61 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 3, BL, >ULN, n=0, 20, 0	16 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 3, PBL, >ULN, n=0, 94, 0	78 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 3, BL, <LLN, n=0, 16, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 3, PBL, <LLN, n=0, 4, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 3, BL, >ULN, n=0, 16, 0	14 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 3, PBL, >ULN, n=0, 4, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 3, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 3, PBL, >ULN, n=0, 21, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 3, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 3, PBL, >ULN, n=0, 21, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 4, BL, >ULN, n=0, 14, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 4, PBL, >ULN, n=0, 43, 0	19 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 4, BL, >ULN, n=0, 14, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 4, PBL, >ULN, n=0, 43, 0	13 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 4, BL, >ULN, n=0, 14, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 4, PBL, >ULN, n=0, 43, 0	27 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 4, BL, >ULN, n=0, 14, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 4, PBL, >ULN, n=0, 45, 0	35 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 4, BL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 4, PBL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 4, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 4, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 4, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 4, PBL, >ULN, n=0, 18, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 4, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 4, PBL, >ULN, n=0, 17, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 5, BL, >ULN, n=0, 5, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 5, PBL, >ULN, n=0, 24, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 5, BL, >ULN, n=0, 5, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 5, PBL, >ULN, n=0, 24, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 5, BL, >ULN, n=0, 5, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 5, PBL, >ULN, n=0, 24, 0	17 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 5, BL, >ULN, n=0, 5, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 5, PBL, >ULN, n=0, 24, 0	20 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 5, BL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 5, PBL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 5, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 5, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 5, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 5, PBL, >ULN, n=0, 5, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 5, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 5, PBL, >ULN, n=0, 5, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 6, BL, >ULN, n=0, 6, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 6, PBL, >ULN, n=0, 9, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 6, BL, >ULN, n=0, 6, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 6, PBL, >ULN, n=0, 9, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 6, BL, >ULN, n=0, 6, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 6, PBL, >ULN, n=0, 9, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 6, BL, >ULN, n=0, 6, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 6, PBL, >ULN, n=0, 9, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 6, BL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 6, PBL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 6, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 6, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 6, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 6, PBL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 6, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 6, PBL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 7, BL, >ULN, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 7, BL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 7, BL, >ULN, n=0, 2, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 7, BL, >ULN, n=0, 2, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 7, BL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 7, PBL, <LLN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 7, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 7, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 7, BL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 7, PBL, >ULN, n=0, 0, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 1, BL, >ULN, n=0, 205, 0	137 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 1, PBL, >ULN, n=0, 169, 0	93 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 1, BL, >ULN, n=0, 205, 0	114 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 1, PBL, >ULN, n=0, 169, 0	67 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 1, BL, >ULN, n=0, 205, 0	173 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 1, PBL, >ULN, n=0, 169, 0	129 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 1, BL, >ULN, n=0, 207, 0	185 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 1, PBL, >ULN, n=0, 168, 0	140 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 1, BL, <LLN, n=0, 203, 0	21 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 1, PBL, <LLN, n=0, 206, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 1, BL, >ULN, n=0, 203, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 1, PBL, >ULN, n=0, 206, 0	167 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 1, BL, >ULN, n=0, 205, 0	144 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	IL-6, TC 1, PBL, >ULN, n=0, 138, 0	79 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 1, BL, >ULN, n=0, 204, 0	129 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Serum amyloid A, TC 1, PBL, >ULN, n=0, 138, 0	68 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 2, BL, >ULN, n=0, 59, 0	32 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgA, TC 2, PBL, >ULN, n=0, 111, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 2, BL, >ULN, n=0, 59, 0	20 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgG, TC 2, PBL, >ULN, n=0, 111, 0	38 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 2, BL, >ULN, n=0, 59, 0	45 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	RF IgM, TC 2, PBL, >ULN, n=0, 111, 0	80 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 2, BL, >ULN, n=0, 60, 0	51 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Anti-CCP, TC 2, PBL, >ULN, n=0, 111, 0	93 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 2, BL, <LLN, n=0, 81, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 2, PBL, <LLN, n=0, 88, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 2, BL, >ULN, n=0, 81, 0	60 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	B-ls, TC 2, PBL, >ULN, n=0, 88, 0	72 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)	Il-6, TC 2, BL, >ULN, n=0, 52, 0	23 Participants

Secondary

Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 2, PBL, CC low, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 2, BL, CC low, n=0, 176, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 2, PBL, CC low, n=0, 196, 0	10 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 2, BL, CC low, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 2, PBL, CC low, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 2, BL, CC high, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 2, PBL, CC high, n=0, 196, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 2, BL, CC high, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 2,PBL, CC high, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 2, BL, CC high, n=0, 117, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 2, PBL, CC high, n=0, 196, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 2, BL, CC high, n=0, 176, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 2, PBL, CC high, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 2, BL, CC high, n=0, 176, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 2, PBL, CC high, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 2, BL, CC low, n=0, 176, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 2, PBL, CC low, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 2, BL, CC low, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 2, PBL, CC low, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 2, BL, CC low, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 2, PBL, CC low, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 2, BL, CC high, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 2, PBL, CC high, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 2, BL, CC high, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 2, PBL, CC high, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 3, BL, CC high, n=0, 116, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 3, PBL, CC high, n=0, 135, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 3, BL, CC high, n=0, 116, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 3, PBL, CC high, n=0, 135, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 3, PBL, CC high, n=0, 135, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 3, PBL, CC high, n=0, 135, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 3, PBL, CC low, n=0, 134, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 3, BL, CC low, n=0, 116, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 3, PBL, CC low, n=0, 134, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 3, BL, CC high, n=0, 116, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 3, PBL, CC high, n=0, 135, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 3, PBL, CC high, n=0, 134, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 3, BL, CC high, n=0, 116, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 3, PBL, CC high, n=0, 134, 0	7 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 3, PBL, CC high, n=0, 135, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 3, PBL, CC high, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 3, PBL, CC low, n=0, 134, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 1, PBL, CC low, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 1, PBL, CC high, n=0, 239, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 1, PBL, CC high, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 3, BL, CC low, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 1, PBL, CC high, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 3, BL, CC high, n=0, 116, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 3, PBL, CC high, n=0, 134, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 3, BL, CC high, n=0, 116, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 3, PBL, CC high, n=0, 134, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 4, BL, CC high, n=0, 67, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 4, PBL, CC high, n=0, 72, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 4, PBL, CC high, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 4, BL, CC high, n=0, 67, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 4, PBL, CC high, n=0, 72, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 1, PBL, CC high, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 1, PBL, CC low, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 1, BL, CC low, n=0, 234, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 1, PBL, CC low, n=0, 239, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 1, PBL, CC low, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 1, BL, CC high, n=0, 234, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 1, PBL, CC high, n=0, 239, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 1,PBL, CC high, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 1, BL, CC high, n=0, 234, 0	11 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 1, PBL, CC high, n=0, 239, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 1, BL, CC high, n=0, 234, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 1, PBL, CC high, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 1, BL, CC high, n=0, 234, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 1, PBL, CC high, n=0, 239, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 1, PBL, CC low, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 1, PBL, CC low, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 1, BL, CC low, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 1, PBL, CC low, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 1, PBL, CC high, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 1, BL, CC high, n=0, 234, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 1, PBL, CC high, n=0, 239, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 2, BL, CC low, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 2, PBL, CC low, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 2, BL, CC high, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 2, PBL, CC high, n=0, 196, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 2, BL, CC high, n=0, 177, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 2, PBL, CC high, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 2, BL, CC high, n=0, 176, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 2, PBL, CC high, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 2, BL, CC high, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 2, PBL, CC high, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 2, BL, CC low, n=0, 176, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 4, BL, CC low, n=0, 67, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 4, PBL, CC low, n=0, 72, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 4, PBL, CC high, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 4, BL, CC high, n=0, 67, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 4, PBL, CC high, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 4, BL, CC high, n=0, 67, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 4, PBL, CC high, n=0, 72, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 4, PBL, CC high, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 4, BL, CC high, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 5, PBL, CC high, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 5, PBL, CC high, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 3, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 5, PBL, CC high, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 5, PBL, CC high, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 6, BL, CC high, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 6, BL, CC low, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 6, BL, CC low, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 6, PBL, CC low, n=0, 11, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 6, BL, CC high, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 6, BL, CC high, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 6, BL, CC low, n=0, 10, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Albumin, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALT, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	ALP, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	AST, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TBIL, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Calcium, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CO2/BCO, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Chloride, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	CK, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Creatinine, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	GGT, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	LDH, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Potassium, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Sodium, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Total Protein, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Urea/BUN, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Uric acid, TC 7, PBL, CC high, n=0, 2, 0	0 Participants

Secondary

Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.

Time frame: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Population: AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.

Arm	Measure	Group	Value (NUMBER)
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	ALT	1 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	ALP	1 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	CK	2 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	CO2/BCO	3 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	GGT	5 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	Creatinine	1 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period	Urea/BUN	1 Participants

Secondary

Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period

The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.

Time frame: From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 48, normal, n=0, 225, 0	150 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 48, abnormal CS, n=0, 225, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 48, abnormal NCS, n=0, 225, 0	71 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 48, NR, n=0, 225, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 72, normal, n=0, 202, 0	133 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 72, abnormal CS, n=0, 202, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 72, abnormal NCS, n=0, 202, 0	67 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 72, NR, n=0, 202, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 96, normal, n=0, 180, 0	119 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 96, abnormal CS, n=0, 180, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 96, abnormal NCS, n=0, 180, 0	60 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 96, NR, n=0, 180, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 120, normal, n=0, 167, 0	120 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 120, abnormal CS, n=0, 167, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 120, abnormal NCS, n=0, 167, 0	46 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 120, NR, n=0, 167, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 144, normal, n=0, 95, 0	68 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 144, abnormal CS, n=0, 95, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 144, abnormal NCS, n=0, 95, 0	26 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period	Week 144, NR, n=0, 95, 0	0 Participants

Secondary

Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \<=3.2 to \>5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=3.2 to \<=5.1); non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1.

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, Good; n=130, 126	17 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, None; n=129, 124	73 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, Good; n=130, 126	16 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, Good; n=129, 124	15 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, Moderate; n=130, 126	51 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, Good; n=130, 126	16 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, None; n=130, 126	63 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, None; n=130, 126	62 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, Moderate; n=130, 126	41 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, Moderate; n=130, 126	49 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, None; n=130, 126	72 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, Moderate; n=129, 124	41 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, Good; n=130, 126	18 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, None; n=130, 126	65 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, Moderate; n=130, 126	37 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, Good; n=130, 126	17 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, None; n=130, 126	75 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, Moderate; n=130, 126	51 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, None; n=130, 126	34 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, Good; n=130, 126	32 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, None; n=130, 126	36 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, Good; n=129, 124	12 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, Moderate; n=129, 124	63 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 4, None; n=129, 124	49 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, Good; n=130, 126	22 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, Moderate; n=130, 126	62 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, Moderate; n=130, 126	56 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 12, None; n=130, 126	38 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, Good; n=130, 126	32 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 16, Moderate; n=130, 126	58 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, Good; n=130, 126	34 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, Moderate; n=130, 126	52 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 20, None; n=130, 126	40 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, Good; n=130, 126	32 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 24, Moderate; n=130, 126	60 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant	Week 8, None; n=130, 126	42 participants

Secondary

Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, Good; n=130, 126	4 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, Moderate; n=130, 126	53 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, Moderate; n=130, 126	58 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, Moderate; n=129, 124	49 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, None; n=130, 126	68 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, Good; n=130, 126	7 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, Good; n=130, 126	8 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, Good; n=130, 126	7 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, Moderate; n=130, 126	45 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, None; n=129, 124	74 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, None; n=130, 126	77 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, Moderate; n=130, 126	57 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, Good; n=130, 126	4 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, None; n=130, 126	70 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, Moderate; n=130, 126	44 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, None; n=130, 126	66 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, None; n=130, 126	82 participants
Placebo	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, Good; n=129, 124	6 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, None; n=130, 126	45 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, Moderate; n=129, 124	50 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, None; n=129, 124	69 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, Good; n=130, 126	8 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, Moderate; n=130, 126	67 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 8, None; n=130, 126	51 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, Good; n=130, 126	17 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, Moderate; n=130, 126	63 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 12, None; n=130, 126	46 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, Good; n=130, 126	15 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, Moderate; n=130, 126	70 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 16, None; n=130, 126	41 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, Good; n=130, 126	22 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, Moderate; n=130, 126	63 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 20, None; n=130, 126	41 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, Good; n=130, 126	14 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 24, Moderate; n=130, 126	67 participants
Ofatumumab 700 mg	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant	Week 4, Good; n=129, 124	5 participants

Secondary

Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low \[relative to lower limit of normal\], CC High \[relative to upper limit of normal\]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 1, BL, CC high, n=0, 224, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 1, PBL, CC high, n=0, 239, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 1, BL, CC low, n=0, 224, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 1, PBL, CC low, n=0, 239, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 1, BL, CC low, n=0, 224, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 1, PBL, CC low, n=0, 239, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 1, BL, CC low, n=0, 232, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 1, PBL, CC low, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 1, BL, CC high, n=0, 221, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 1, PBL, CC high, n=0, 239, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 1, BL, CC low, n=0, 224, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 1, PBL, CC low, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 1, BL, CC low, n=0, 224, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 1, PBL, CC low, n=0, 239, 0	8 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 1, BL, CC high, n=0, 224, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 1,PBL, CC high, n=0, 239, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 1, BL, CC low, n=0, 224, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 1, PBL, CC low, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 1, BL, CC high, n=0, 224, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 1, PBL, CC high, n=0, 239, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 2, BL, CC high, n=0, 171, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 2, PBL, CC high, n=0, 195, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 2, BL, CC low, n=0, 173, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 2, PBL, CC low, n=0, 195, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 2, BL, CC low, n=0, 172, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 2, PBL, CC low, n=0, 195, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 2, BL, CC low, n=0, 177, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 2, PBL, CC low, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 2, BL, CC high, n=0, 170, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 2, PBL, CC high, n=0, 195, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 2, BL, CC low, n=0, 172, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 2, PBL, CC low, n=0, 195, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 2, BL, CC low, n=0, 171, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 2, PBL, CC low, n=0, 195, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 2, BL, CC high, n=0, 171, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 2,PBL, CC high, n=0, 195, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 2, BL, CC low, n=0, 171, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 2, PBL, CC low, n=0, 195, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 2, BL, CC high, n=0, 171, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 2, PBL, CC high, n=0, 195, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 3, BL, CC high, n=0, 114, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 3, PBL, CC high, n=0, 134, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 3, BL, CC low, n=0, 115, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 3, BL, CC low, n=0, 115, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 3, BL, CC low, n=0, 117, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 3, BL, CC high, n=0, 115, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 3, PBL, CC high, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 3, BL, CC low, n=0, 115, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 3, BL, CC low, n=0, 114, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 3, PBL, CC low, n=0, 134, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 3, BL, CC high, n=0, 114, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 3,PBL, CC high, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 3, BL, CC low, n=0, 114, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 3, PBL, CC low, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 3, BL, CC high, n=0, 114, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 3, PBL, CC high, n=0, 134, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 4, BL, CC high, n=0, 66, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 4, PBL, CC high, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 4, BL, CC low, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 4, BL, CC low, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 4, BL, CC low, n=0, 67, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 4, BL, CC high, n=0, 65, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 4, BL, CC low, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 4, BL, CC low, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 4, PBL, CC low, n=0, 72, 0	5 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 4, BL, CC high, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 4,PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 4, BL, CC low, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 4, PBL, CC low, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 4, BL, CC high, n=0, 66, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 4, PBL, CC high, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 5, PBL, CC high, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 5, BL, CC low, n=0, 29, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 5,PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 5, BL, CC low, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 5, PBL, CC low, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 5, BL, CC high, n=0, 29, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 5, PBL, CC high, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 6, BL, CC low, n=0, 11, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 6,PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 6, BL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 6, PBL, CC low, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 6, BL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 6, PBL, CC high, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Eosinophils, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HCT, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Hb, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	Lymphocytes, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	PC, TC 7, PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	RBC count, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	TNUE, TC 7,PBL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 7, BL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 7, PBL, CC low, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 7, BL, CC high, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	WBC count, TC 7, PBL, CC high, n=0, 2, 0	0 Participants

Secondary

Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low \[relative to lower limit of normal\], CC High \[relative to upper limit of normal\]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.

Time frame: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Arm	Measure	Group	Value (NUMBER)
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period	Eosinophils	1 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period	Total neutrophils	2 Participants
Placebo or OFA 700 mg: FU Period	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period	Platelet count	1 Participants

Secondary

Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury \[mmHg\]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.

Time frame: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 3, BL, >ULN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 6, PBL, >ULN, n=0, 11, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 1, BL, <LLN, n=0, 242, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 1, PBL, <LLN, n=0, 243, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 1, BL, >ULN, n=0, 242, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 1, PBL, >ULN, n=0, 243, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 1, BL, <LLN, n=0, 242, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 1, PBL, <LLN, n=0, 243, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 1, BL, >ULN, n=0, 242, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 1, PBL, >ULN, n=0, 243, 0	15 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 1, BL, <LLN, n=0, 243, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 1, PBL, <LLN, n=0, 243, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 1, BL, >ULN, n=0, 243, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 1, PBL, >ULN, n=0, 243, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 2, BL, <LLN, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 2, PBL, <LLN, n=0, 198, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 2, BL, >ULN, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 2, PBL, >ULN, n=0, 198, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 2, BL, <LLN, n=0, 196, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 2, PBL, <LLN, n=0, 198, 0	9 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 2, BL, >ULN, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 2, PBL, >ULN, n=0, 198, 0	12 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 2, BL, <LLN, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 2, PBL, <LLN, n=0, 198, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 2, BL, >ULN, n=0, 196, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 2, PBL, >ULN, n=0, 198, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 3, BL, <LLN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 3, PBL, <LLN, n=0, 136, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 3, BL, >ULN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 3, PBL, >ULN, n=0, 136, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 3, BL, <LLN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 3, PBL, <LLN, n=0, 136, 0	6 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 3, BL, >ULN, n=0, 136, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 3, PBL, >ULN, n=0, 136, 0	3 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 3, BL, <LLN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 3, PBL, <LLN, n=0, 136, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 3, PBL, >ULN, n=0, 136, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 4, BL, <LLN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 4, PBL, <LLN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 4, BL, >ULN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 4, PBL, >ULN, n=0, 72, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 4, BL, <LLN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 4, PBL, <LLN, n=0, 72, 0	4 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 4, BL, >ULN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 4, PBL, >ULN, n=0, 72, 0	2 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 4, BL, <LLN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 4, PBL, <LLN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 4, BL, >ULN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 4, PBL, >ULN, n=0, 72, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 5, BL, <LLN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 5, PBL, <LLN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 5, BL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 5, PBL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 5, BL, <LLN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 5, PBL, <LLN, n=0, 31, 0	1 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 5, BL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 5, PBL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 5, BL, <LLN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 5, PBL, <LLN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 5, BL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 5, PBL, >ULN, n=0, 31, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 6, BL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 6, PBL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 6, BL, >ULN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 6, PBL, >ULN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 6, BL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 6, PBL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 6, BL, >ULN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 6, BL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 6, PBL, <LLN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 6, BL, >ULN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 6, PBL, >ULN, n=0, 11, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 7, BL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 7, PBL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 7, BL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	DBP, TC 7, PBL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 7, BL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 7, PBL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 7, BL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	SBP, TC 7, PBL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 7, BL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 7, PBL, <LLN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 7, BL, >ULN, n=0, 2, 0	0 Participants
Ofatumumab 700 mg	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course	HR, TC 7, PBL, >ULN, n=0, 2, 0	0 Participants

Secondary

Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab

Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.

Time frame: From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Placebo or OFA 700 mg: FU Period	Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab	Relative to first dose, n=0, 0, 133	22.998 Months
Placebo or OFA 700 mg: FU Period	Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab	Relative to last dose, n=0, 0, 128	13.832 Months

Secondary

Time to Retreatment, by Ofatumumab Treatment Course

Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.

Time frame: From Baseline up to Week 144

Population: AT Population. Only those participants who were retreated from Week 24 were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 1, n=0, 198, 0	34.26 Weeks	Standard Deviation 15.828
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 2, n=0, 136, 0	34.50 Weeks	Standard Deviation 15.151
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 3, n=0, 72, 0	28.83 Weeks	Standard Deviation 10.713
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 4, n=0, 31, 0	20.82 Weeks	Standard Deviation 6.952
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 5, n=0, 11, 0	19.94 Weeks	Standard Deviation 5.411
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 6, n=0, 2, 0	17.86 Weeks	Standard Deviation 0.404
Ofatumumab 700 mg	Time to Retreatment, by Ofatumumab Treatment Course	TC 7, n=0, 0, 0	NA Weeks	—

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24

Change From Baseline in CRP at Week 24

Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant

Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant

Change From Baseline in ESR at Week 24

Change From Baseline in HAQ-DI Score at Week 24

Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24

Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24

Change From Baseline in Participant-assessed Global Disease Score at Week 24

Change From Baseline in Swollen Joint Count at Week 24

Change From Baseline in Tender Joint Count at Week 24

Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24

Change From Baseline in the Participant-assessed Pain Score at Week 24

Change From Baseline in the Physician-assessed Global Disease Score at Week 24

Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24

Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24

Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant

Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)

Median ACRn at Weeks 4, 8, 12, 16, 20, and 24

Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course

Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course

Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course

Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course

Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)

Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20

Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24

Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24

Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With Any Serious Adverse Event During the Follow-up Period

Number of Participants With a Positive JC Virus Test Result During the Follow-up Period

Number of Participants With Clinical Remission at Week 24

Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period

Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)

Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period

Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period

Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant

Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant

Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period

Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course

Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab

Time to Retreatment, by Ofatumumab Treatment Course