Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640328

Acronym

OMS115102

Enrollment

Registered

2008-03-21

Start date

2008-05-31

Completion date

2011-10-31

Last updated

2017-04-11

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

Conditions

Multiple Sclerosis

Keywords

relapsing forms of multiple sclerosis, ofatumumab, multiple sclerosis

Brief summary

The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.

Detailed description

The trial consists of two phases, a 48 week treatment period, followed by an individualized treatment period of up to two years. Patients are treated in cohorts of increasing doses (100 mg, 300 mg and 700 mg) with 12 patients in each dose cohort. Within each cohort patients are randomized asymmetrically in a 2:1 ratio such that eight patients will receive ofatumumab and four patients will receive placebo. After 24 weeks the patients randomized to placebo will be treated with the active dose for the cohort. For blinding purposes, patients randomized to the active dose will be treated with placebo after 24 weeks. Thus, each patient will receive two administrations of trial product with 24 weeks follow-up resulting in a total treatment period of 48 weeks duration. An Independent Data Monitoring Committee (IDMC) will review and evaluate the safety data of each cohort, a minimum of 4 weeks data including the week 4 Magnetic Resonance Imaging (MRI) from at least 10 patients, to consider if progression to the next higher dose cohort is acceptable. The trial product is administered as two infusions separated by two weeks. Clinical assessment and Gadolinium enhanced (Gd-enhanced) MRI scan will be performed at weeks -4, 0, 2, 4, and every 4 weeks until week 48. The MRI scan at week 2 is carried out for safety assessment prior to administering the second infusion in the first treatment course. When patients in all dose cohorts have been dosed and have had week 4 MRI scans performed, an IDMC will review all available safety data. After completion of week 48 patients will be followed to monitor B-cell and IgG normalization. B-cell levels will be monitored every 12 weeks until CD19+ cells have returned to baseline level (Visit 3) or normalized level. If the B-cell levels are not normalized after two years the patient should be followed until either the IgG or the B-cell levels are normalized (see Section 9.2.4 for details). During this period Gd-enhanced MRI follow up scans will be performed every 12 weeks to evaluate potential rebound, safety and for Progressive Multifocal Leukoencephalopathy (PML) monitoring.

Interventions

DRUGOfatumumab 100

100mg

DRUGOfatumumab 300

300mg

DRUGOfatumumab 700

700mg

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria * Patients with: * At least two confirmed relapses within the last 24 months or * At least one confirmed relapse within the last 12 months or * One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening. * Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening * Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase * Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period * Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.

Exclusion criteria

* Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS) or Progressive Relapsing Multiple Sclerosis (PRMS) or Neuromyelitis optica * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML * Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS * Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access * Patients who have had the following treatments: * Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-Cluster of Differentiation (CD4), cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time * Anti-CD20 treatments or any monoclonal antibodies at any time * Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and Interferon Beta (IFN-b). * Glatiramer Acetate or IFN-b within three months prior to the randomization in the trial. * Glucocorticoids or Adrenocorticotropic Hormone (ACTH) within one month prior to the screening in the trial. * Receipt of a live vaccine within one month prior to screening in the trial. * Plasmapheresis for treatment of relapses within 2 months prior to randomization in the trial. * Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial. * Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the sponsors medical monitor * Past or current history of medically significant adverse effects (including allergic reactions) from: * Cetirizine * Prednisolone * Paracetamol/acetaminophen * Plasma proteins or a known hypersensitivity to components of the investigational product. * Past or current malignancy, except for * Cervical carcinoma Stage 1B or less * Non-invasive basal cell and squamous cell skin carcinoma * Cancer diagnoses with a complete response of a duration of \> 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response * Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy. * Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subject's health (i.e. acute ischemia, left bundle branch or bifascicular block) * Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric or neurological disease which may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol. * History of severe, clinically significant Central Nervous System (CNS) trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease * Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C. Any previous serious infections should be discussed with the sponsors medical monitor (e.g. opportunistic or atypical infections) * Female patients who are pregnant or nursing. * Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed with the medical monitor. * Current participation in any other interventional clinical trial. Participation in non-interventional trial requires approval of the protocol by the sponsor * Serum vitamin B12 below lower limit of normal * Positive polymerase chain reaction (PCR) screening for John Cunningham Virus (JC Virus) as measured by qualitative plasma and/or white blood cell JCV DNA * Serologic evidence of Hepatitis B (HB) infection based on the results of testing for Hepatitis B Surface Antigen (HBsAg), anti- Hepatitis B Core (HBc) and anti- Hepatitis B Surface (HBs) antibodies with eligibility based on the results as follows: * Patients positive for HBsAg are excluded * Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible * Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody (indicating past vaccination) are eligible * Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA, which if positive will exclude the patient from participation * Patient with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered eligible for the trial. * Positive serology for HIV * Screening laboratory values: * White Blood Cell (WBC) \< 3.0 x 109/L * Neutrophils \< 2 x 109/L * Platelets \< 100 x 109/L * Circulating IgG level \< lower limit of normal (according to central laboratory range) * Serum Alanine Aminotransferase (S-ALAT) \> 2.5 times the upper limit of normal (according to central laboratory range) * Serum Alpha Fetoprotein (S-AP) \> 2.0 times the upper limit of normal (according to central laboratory range) * Serum Aspartate Aminotransferase (ASAT) \>3.0 times the upper limit of normal (according to central laboratory range) * Bilirubin \> 1.5 times the upper limit of normal (according to central laboratory range) * S-creatinine \> the upper limit of normal (according to central laboratory range) * CD4 count \<500 cells/mm3, CD4:CD8 \<0.9 * Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder). * Positive test for Hepatitis C antibody confirmed with a Hepatitis C real time (RT) PCR assay. Patients who are positive for Hepatitis C antibody and negative when the Hepatitis C RT PCR assay is performed will be eligible for the study. Patients who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RT PCR assay is performed will not be eligible for the study. * Positive test results for tuberculosis using the QuantiFERON test and/or Chest X-ray findings suggestive of tuberculosis (TB). For patients who have had a Chest X-ray performed within the past 6 months without any findings indicative of TB, QuantiFERON test alone may be performed.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)	Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)	Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)	Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)	Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)	The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)	The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Number of Participants With Any Adverse Event	First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period.
Number of Participants With the Indicated Critical Adverse Events (CAEs)	FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	A CAE=treatment-related (TR) grade (G) \>=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)	Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.
Number of Participants With Abnormal Physical Examination Findings	FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis \[a brain and spinal cord disease\]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)	Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)	Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)	Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.

Secondary

Measure	Time frame	Description
Total Volume of T2 Lesions at Week 24 and Week 48	Visit 10 (Week 24) and Visit 17 (Week 48)	The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.	The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.	The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.	The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.	The peripheral blood for each participant was collected and analyzed for tmax.
Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2 and 24-26	The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.
The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2 and 24-26	The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.
Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2 and 24-26	The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)	The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.

Participant flow

Pre-assignment details

In all 3 dose cohorts, participants in the active/placebo group received treatment with ofatumumab during the First Treatment Period and placebo during the Second Treatment Period. Participants in the placebo/active group received treatment with placebo during the First Treatment Period and ofatumumab during the second treatment period.

Participants by arm

Arm	Count
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.	8
300 mg Ofa/Matching Placebo Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.	11
700 mg Ofa/Matching Placebo Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.	7
Matching Placebo/100 mg Ofa Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.	4
Matching Placebo/300 mg Ofa Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.	4
Matching Placebo/700 mg Ofa Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.	4
Total	38

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003	FG004
First Treatment Period (Weeks 0-24)	Adverse Event	1	0	0	0
IFUP (Week 48 to Individual Termination)	Not Recommended - Informed Consent Form	1	0	1	0
IFUP (Week 48 to Individual Termination)	Withdrawal by Subject	0	1	0	0
Second Treatment Period (Weeks 24-48)	Adverse Event	0	0	0	1

Baseline characteristics

Characteristic	100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	300 mg Ofa/Matching Placebo	700 mg Ofa/Matching Placebo	Matching Placebo/100 mg Ofa	Matching Placebo/300 mg Ofa	Matching Placebo/700 mg Ofa	Total
Age, Continuous	38.0 Years STANDARD_DEVIATION 9	36.6 Years STANDARD_DEVIATION 7	33.7 Years STANDARD_DEVIATION 8.4	37.0 Years STANDARD_DEVIATION 6.5	27.0 Years STANDARD_DEVIATION 2.2	44.0 Years STANDARD_DEVIATION 8.1	36.3 Years STANDARD_DEVIATION 7.9
Race/Ethnicity, Customized White/Caucasian	8 participants	11 participants	7 participants	4 participants	4 participants	4 participants	38 participants
Sex: Female, Male Female	6 Participants	6 Participants	4 Participants	3 Participants	3 Participants	0 Participants	22 Participants
Sex: Female, Male Male	2 Participants	5 Participants	3 Participants	1 Participants	1 Participants	4 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	8 / 8	10 / 11	7 / 7	3 / 4	4 / 4	4 / 4
serious Total, serious adverse events	0 / 8	2 / 11	0 / 7	1 / 4	0 / 4	0 / 4

Outcome results

Primary

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)

Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	5.3 millimeters of mercury	Standard Deviation 11.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	11.0 millimeters of mercury	Standard Deviation 19.7
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	6.6 millimeters of mercury	Standard Deviation 4.6
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	2.0 millimeters of mercury	Standard Deviation 14.5
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	2.1 millimeters of mercury	Standard Deviation 12
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	-2.5 millimeters of mercury	Standard Deviation 12.3
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	-2.3 millimeters of mercury	Standard Deviation 11.1
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	-2.5 millimeters of mercury	Standard Deviation 13.9
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	-4.9 millimeters of mercury	Standard Deviation 8.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	0.1 millimeters of mercury	Standard Deviation 7.8
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	-3.1 millimeters of mercury	Standard Deviation 14.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	-5.4 millimeters of mercury	Standard Deviation 9.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	-3.5 millimeters of mercury	Standard Deviation 7.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	-2.3 millimeters of mercury	Standard Deviation 7.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	1.5 millimeters of mercury	Standard Deviation 11.3
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	3.0 millimeters of mercury	Standard Deviation 4.7
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	3.3 millimeters of mercury	Standard Deviation 5.8
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	1.7 millimeters of mercury	Standard Deviation 10.4
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	1.0 millimeters of mercury	Standard Deviation 9
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	4.0 millimeters of mercury	Standard Deviation 4.9
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4	-6.5 millimeters of mercury	Standard Deviation 9.5
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4	6.0 millimeters of mercury	Standard Deviation 5.8
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4	4.5 millimeters of mercury	Standard Deviation 1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)	Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4	-1.8 millimeters of mercury	Standard Deviation 2.2

Primary

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)

Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 7, 0, 4, 2, 0	-0.6 Units per milliliter	Standard Deviation 4.1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 48; n=4, 0, 0, 1, 0, 0	3.8 Units per milliliter	Standard Deviation 7.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 48; n=4, 0, 0, 1, 0, 0	NA Units per milliliter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 7, 0, 4, 2, 0	-7.1 Units per milliliter	Standard Deviation 12.9
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 7, 0, 4, 2, 0	2.8 Units per milliliter	Standard Deviation 9.1
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 48; n=4, 0, 0, 1, 0, 0	-31.0 Units per milliliter	Standard Deviation 0
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 7, 0, 4, 2, 0	-19.5 Units per milliliter	Standard Deviation 24.7
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)	Week 48; n=4, 0, 0, 1, 0, 0	NA Units per milliliter	—

Primary

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)

The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	-0.3 beats per minute	Standard Deviation 11.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-0.1 beats per minute	Standard Deviation 9.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	1.6 beats per minute	Standard Deviation 8.4
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	0.4 beats per minute	Standard Deviation 11.9
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	0.6 beats per minute	Standard Deviation 10.7
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-3.0 beats per minute	Standard Deviation 10.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	1.3 beats per minute	Standard Deviation 13.8
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-5.5 beats per minute	Standard Deviation 10
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	2.0 beats per minute	Standard Deviation 8
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-0.3 beats per minute	Standard Deviation 9.5
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	3.8 beats per minute	Standard Deviation 8.1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	8.0 beats per minute	Standard Deviation 5

Primary

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)

The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	-0.1 Degrees Celsius	Standard Deviation 0.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-0.1 Degrees Celsius	Standard Deviation 0.4
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	0.1 Degrees Celsius	Standard Deviation 0.2
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	0.1 Degrees Celsius	Standard Deviation 0.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	-0.2 Degrees Celsius	Standard Deviation 0.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	0.1 Degrees Celsius	Standard Deviation 0.5
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	-0.1 Degrees Celsius	Standard Deviation 0.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	-0.1 Degrees Celsius	Standard Deviation 0.2
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	0.3 Degrees Celsius	Standard Deviation 0.5
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	0.2 Degrees Celsius	Standard Deviation 0.3
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 24; n=8, 10, 7, 4, 4, 4	-0.3 Degrees Celsius	Standard Deviation 0.3
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)	Week 48; n=8, 11, 7, 4, 3, 4	0.1 Degrees Celsius	Standard Deviation 0.3

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	0.1 grams per liter	Standard Deviation 2.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	-2.00 grams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	-0.6 grams per liter	Standard Deviation 2.5
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	-0.2 grams per liter	Standard Deviation 3.1
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	-0.5 grams per liter	Standard Deviation 2.5
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	1.3 grams per liter	Standard Deviation 1.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	1.4 grams per liter	Standard Deviation 3
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	-1.6 grams per liter	Standard Deviation 3.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	-1.1 grams per liter	Standard Deviation 5.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	0.4 grams per liter	Standard Deviation 4
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	-1.2 grams per liter	Standard Deviation 6.1
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 6, 4, 4, 4	2.0 grams per liter	Standard Deviation 2.4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 11, 7, 4, 3, 4	1.1 grams per liter	Standard Deviation 1.5

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	2.0 Units per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	2.0 Units per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	7.1 Units per liter	Standard Deviation 10.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	2.8 Units per liter	Standard Deviation 5.3
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	16.0 Units per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	0.6 Units per liter	Standard Deviation 2.6
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	3.6 Units per liter	Standard Deviation 5.1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	4.8 Units per liter	Standard Deviation 9
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	7.6 Units per liter	Standard Deviation 10.7
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	0.6 Units per liter	Standard Deviation 4.7
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	1.6 Units per liter	Standard Deviation 6.3
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	4.7 Units per liter	Standard Deviation 10
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	3.8 Units per liter	Standard Deviation 11.9
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	3.1 Units per liter	Standard Deviation 8.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	NA Units per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	1.5 Units per liter	Standard Deviation 3
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	-0.2 Units per liter	Standard Deviation 3.1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	0.6 Units per liter	Standard Deviation 7.4
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	9.1 Units per liter	Standard Deviation 12.6
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	-1.7 Units per liter	Standard Deviation 6.4
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	NA Units per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	0.3 Units per liter	Standard Deviation 2.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	2.7 Units per liter	Standard Deviation 8.3
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	-4.3 Units per liter	Standard Deviation 9.3
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	13.0 Units per liter	Standard Deviation 20.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	-9.5 Units per liter	Standard Deviation 28.6
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	7.3 Units per liter	Standard Deviation 24.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	5.3 Units per liter	Standard Deviation 17.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	-13.3 Units per liter	Standard Deviation 28.5
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	NA Units per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	0.7 Units per liter	Standard Deviation 4.7
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	5.7 Units per liter	Standard Deviation 7.6
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	NA Units per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	5.3 Units per liter	Standard Deviation 5.4
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	4.3 Units per liter	Standard Deviation 3.2
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	2.3 Units per liter	Standard Deviation 10.6
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	0.7 Units per liter	Standard Deviation 8.1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4	8.8 Units per liter	Standard Deviation 8.3
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4	12.5 Units per liter	Standard Deviation 12.9
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, ALT; n=8, 11, 7, 4, 3, 4	8.0 Units per liter	Standard Deviation 20.4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, ALT; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, AST; n=1, 0, 0, 0, 0, 0	NA Units per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Alkaline phosphatase; n=1,0,0,0,0,0	NA Units per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, ALT; n=8, 10, 6, 4, 4, 4	0 Units per liter	Standard Deviation 13
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, AST; n=8, 11, 7, 4, 3, 4	3.3 Units per liter	Standard Deviation 10.7
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, AST; n=8, 10, 6, 4, 4, 4	-1.0 Units per liter	Standard Deviation 6.1

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	0.8 Giga (10^9) per liter	Standard Deviation 33.3
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	-0.11 Giga (10^9) per liter	Standard Deviation 0.36
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	0.20 Giga (10^9) per liter	Standard Deviation 0.31
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-6.5 Giga (10^9) per liter	Standard Deviation 17.3
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	-0.60 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	0 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	0.4 Giga (10^9) per liter	Standard Deviation 0.9
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	0.7 Giga (10^9) per liter	Standard Deviation 1.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	-0.20 Giga (10^9) per liter	Standard Deviation 0.07
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	0 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	0.7 Giga (10^9) per liter	Standard Deviation 1.6
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	0 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	0 Giga (10^9) per liter	Standard Deviation 0.05
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	1.30 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	0.5 Giga (10^9) per liter	Standard Deviation 1.1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	1.90 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	0.15 Giga (10^9) per liter	Standard Deviation 1.03
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	-20.0 Giga (10^9) per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0.05
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	-0.1 Giga (10^9) per liter	Standard Deviation 1.7
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	-0.01 Giga (10^9) per liter	Standard Deviation 0.12
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-16.3 Giga (10^9) per liter	Standard Deviation 74.2
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	0.2 Giga (10^9) per liter	Standard Deviation 1.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	0.6 Giga (10^9) per liter	Standard Deviation 2.4
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	-0.36 Giga (10^9) per liter	Standard Deviation 0.67
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	-0.07 Giga (10^9) per liter	Standard Deviation 0.23
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	1 Giga (10^9) per liter	Standard Deviation 2.2
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	10.8 Giga (10^9) per liter	Standard Deviation 44
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	-0.04 Giga (10^9) per liter	Standard Deviation 0.16
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	-0.05 Giga (10^9) per liter	Standard Deviation 0.13
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	-0.28 Giga (10^9) per liter	Standard Deviation 0.47
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	-0.3 Giga (10^9) per liter	Standard Deviation 1.1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	-0.19 Giga (10^9) per liter	Standard Deviation 0.78
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	-0.1 Giga (10^9) per liter	Standard Deviation 3.3
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	0.02 Giga (10^9) per liter	Standard Deviation 0.15
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	0.04 Giga (10^9) per liter	Standard Deviation 0.09
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 3.8
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	0.15 Giga (10^9) per liter	Standard Deviation 0.36
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	0.00 Giga (10^9) per liter	Standard Deviation 0.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	-0.4 Giga (10^9) per liter	Standard Deviation 1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	7.6 Giga (10^9) per liter	Standard Deviation 39.7
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	0.02 Giga (10^9) per liter	Standard Deviation 0.17
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-10.1 Giga (10^9) per liter	Standard Deviation 14.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	-0.3 Giga (10^9) per liter	Standard Deviation 1.6
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	-0.37 Giga (10^9) per liter	Standard Deviation 0.31
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	0.07 Giga (10^9) per liter	Standard Deviation 0.06
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	-0.1 Giga (10^9) per liter	Standard Deviation 1.5
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	0.3 Giga (10^9) per liter	Standard Deviation 29.5
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	-0.07 Giga (10^9) per liter	Standard Deviation 0.06
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	-0.9 Giga (10^9) per liter	Standard Deviation 0.6
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	-0.50 Giga (10^9) per liter	Standard Deviation 0.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	0.03 Giga (10^9) per liter	Standard Deviation 0.06
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	-0.4 Giga (10^9) per liter	Standard Deviation 0.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-13.7 Giga (10^9) per liter	Standard Deviation 20.6
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	-0.65 Giga (10^9) per liter	Standard Deviation 0.78
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	-3.7 Giga (10^9) per liter	Standard Deviation 1.7
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	-0.20 Giga (10^9) per liter	Standard Deviation 0.28
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	5.8 Giga (10^9) per liter	Standard Deviation 36.2
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	-0.8 Giga (10^9) per liter	Standard Deviation 1.7
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	-0.40 Giga (10^9) per liter	Standard Deviation 0.17
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	-0.60 Giga (10^9) per liter	Standard Deviation 0.79
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	0.7 Giga (10^9) per liter	Standard Deviation 5.9
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	-0.23 Giga (10^9) per liter	Standard Deviation 0.21
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	-2.9 Giga (10^9) per liter	Standard Deviation 1.3
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	-0.04 Giga (10^9) per liter	Standard Deviation 0.28
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-34.3 Giga (10^9) per liter	Standard Deviation 47.3
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4	0.4 Giga (10^9) per liter	Standard Deviation 0.7
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4	0.9 Giga (10^9) per liter	Standard Deviation 0.9
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4	1.0 Giga (10^9) per liter	Standard Deviation 0.7
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4	0.03 Giga (10^9) per liter	Standard Deviation 0.13
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4	0.13 Giga (10^9) per liter	Standard Deviation 0.25
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4	0.03 Giga (10^9) per liter	Standard Deviation 0.05
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4	0.12 Giga (10^9) per liter	Standard Deviation 0.21
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4	-11.0 Giga (10^9) per liter	Standard Deviation 38.4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4	-4.8 Giga (10^9) per liter	Standard Deviation 34.8
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4	0 Giga (10^9) per liter	Standard Deviation 0
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4	-0.25 Giga (10^9) per liter	Standard Deviation 0.45
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4	0.2 Giga (10^9) per liter	Standard Deviation 0.7
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0	NA Giga (10^9) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4	0.05 Giga (10^9) per liter	Standard Deviation 0.1

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	-1.00 millimoles per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	0.10 millimoles per liter	Standard Deviation 0.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	1.00 millimoles per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	0.4 millimoles per liter	Standard Deviation 2.7
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	1.77 millimoles per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	0.00 millimoles per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	0.5 millimoles per liter	Standard Deviation 1.6
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	4.21 millimoles per liter	Standard Deviation 0.11
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	0.13 millimoles per liter	Standard Deviation 1.4
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	0.6 millimoles per liter	Standard Deviation 2.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	1.00 millimoles per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	-0.12 millimoles per liter	Standard Deviation 0.59
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	-0.07 millimoles per liter	Standard Deviation 0.35
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	-2.3 millimoles per liter	Standard Deviation 1.6
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	-0.0 millimoles per liter	Standard Deviation 2.9
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	-0.07 millimoles per liter	Standard Deviation 3.1
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	-0.05 millimoles per liter	Standard Deviation 1.32
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	0.06 millimoles per liter	Standard Deviation 0.52
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	-1.1 millimoles per liter	Standard Deviation 2.6
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	-0.5 millimoles per liter	Standard Deviation 2.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	-0.8 millimoles per liter	Standard Deviation 1.6
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	-0.7 millimoles per liter	Standard Deviation 2.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	0.25 millimoles per liter	Standard Deviation 0.95
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	0.39 millimoles per liter	Standard Deviation 1.37
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	4.43 millimoles per liter	Standard Deviation 0.44
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	0.03 millimoles per liter	Standard Deviation 0.27
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	0.6 millimoles per liter	Standard Deviation 1.3
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	-0.6 millimoles per liter	Standard Deviation 2.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	0.64 millimoles per liter	Standard Deviation 1.23
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	0.7 millimoles per liter	Standard Deviation 1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	4.18 millimoles per liter	Standard Deviation 0.34
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	-0.05 millimoles per liter	Standard Deviation 0.51
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	0.4 millimoles per liter	Standard Deviation 1.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	-0.19 millimoles per liter	Standard Deviation 0.68
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	-1.2 millimoles per liter	Standard Deviation 1.3
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	4.23 millimoles per liter	Standard Deviation 0.32
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	1.5 millimoles per liter	Standard Deviation 3.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	0.21 millimoles per liter	Standard Deviation 0.42
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	-0.63 millimoles per liter	Standard Deviation 1.01
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	0.5 millimoles per liter	Standard Deviation 1.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	-0.6 millimoles per liter	Standard Deviation 0.8
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	0.6 millimoles per liter	Standard Deviation 0.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	0.09 millimoles per liter	Standard Deviation 0.56
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	-0.5 millimoles per liter	Standard Deviation 3.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	-0.30 millimoles per liter	Standard Deviation 1.04
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	-0.64 millimoles per liter	Standard Deviation 0.44
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	-2.0 millimoles per liter	Standard Deviation 1.3
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	-0.20 millimoles per liter	Standard Deviation 0.63
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	-0.7 millimoles per liter	Standard Deviation 2.1
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	1.9 millimoles per liter	Standard Deviation 3.1
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	-0.7 millimoles per liter	Standard Deviation 1.2
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	0.8 millimoles per liter	Standard Deviation 2.1
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	0.08 millimoles per liter	Standard Deviation 0.63
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	1.00 millimoles per liter	Standard Deviation 2.2
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	3.98 millimoles per liter	Standard Deviation 0.1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Urea; n=8, 11, 7, 4, 3, 4	-0.17 millimoles per liter	Standard Deviation 0.46
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Glucose; n=8, 10, 7, 4, 2, 4	0.27 millimoles per liter	Standard Deviation 0.79
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4	-0.6 millimoles per liter	Standard Deviation 4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4	1.0 millimoles per liter	Standard Deviation 2.3
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Urea; n=8, 10, 6, 4, 4, 4	-0.1 millimoles per liter	Standard Deviation 0.4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Glucose; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Sodium; n=8, 10, 6, 4, 4, 4	0.5 millimoles per liter	Standard Deviation 2.1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Urea; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Potassium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Potassium; n=8, 10, 6, 4, 4, 4	-0.00 millimoles per liter	Standard Deviation 0.16
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Glucose; n=8, 10, 7, 4, 4, 4	-0.22 millimoles per liter	Standard Deviation 0.5
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Sodium; n=1, 0, 0, 0, 0, 0	NA millimoles per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Sodium; n=8, 11, 7, 4, 3, 4	0.8 millimoles per liter	Standard Deviation 1
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Potassium; n=8, 10, 6, 4, 4, 4	4.20 millimoles per liter	Standard Deviation 0.32

Primary

Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	0.7 Micromoles per liter (µmol/L)	Standard Deviation 5.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	3.2 Micromoles per liter (µmol/L)	Standard Deviation 11.8
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	1.5 Micromoles per liter (µmol/L)	Standard Deviation 4.9
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	3.0 Micromoles per liter (µmol/L)	Standard Deviation 8.7
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	-4.70 Micromoles per liter (µmol/L)	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	11.5 Micromoles per liter (µmol/L)	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	-0.1 Micromoles per liter (µmol/L)	Standard Deviation 7.6
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	-1.9 Micromoles per liter (µmol/L)	Standard Deviation 5.3
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	-0.0 Micromoles per liter (µmol/L)	Standard Deviation 4
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	-0.1 Micromoles per liter (µmol/L)	Standard Deviation 4.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	-0.3 Micromoles per liter (µmol/L)	Standard Deviation 4.1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	1.5 Micromoles per liter (µmol/L)	Standard Deviation 3.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	1.2 Micromoles per liter (µmol/L)	Standard Deviation 2.2
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	2.5 Micromoles per liter (µmol/L)	Standard Deviation 4.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	3.5 Micromoles per liter (µmol/L)	Standard Deviation 6.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	2.5 Micromoles per liter (µmol/L)	Standard Deviation 5.7
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	0.7 Micromoles per liter (µmol/L)	Standard Deviation 3.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	0.5 Micromoles per liter (µmol/L)	Standard Deviation 4
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	-2.6 Micromoles per liter (µmol/L)	Standard Deviation 3.5
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	-2.9 Micromoles per liter (µmol/L)	Standard Deviation 7.8
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	-2.8 Micromoles per liter (µmol/L)	Standard Deviation 1
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	-5.0 Micromoles per liter (µmol/L)	Standard Deviation 6.5
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Creatinine; n=8, 11, 7, 4, 3, 4	2.0 Micromoles per liter (µmol/L)	Standard Deviation 12.5
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4	0.6 Micromoles per liter (µmol/L)	Standard Deviation 2.8
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, Creatinine; n=1, 0, 0, 0, 0, 0	NA Micromoles per liter (µmol/L)	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Creatinine; n=8, 10, 6, 4, 4, 4	-1.2 Micromoles per liter (µmol/L)	Standard Deviation 4
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4	0.3 Micromoles per liter (µmol/L)	Standard Deviation 5.3

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.05 Pico (10^12) per liter	Standard Deviation 0.26
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.06 Pico (10^12) per liter	Standard Deviation 0.25
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	-0.08 Pico (10^12) per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.12 Pico (10^12) per liter	Standard Deviation 0.34
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.11 Pico (10^12) per liter	Standard Deviation 0.33
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Pico (10^12) per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.12 Pico (10^12) per liter	Standard Deviation 0.25
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.02 Pico (10^12) per liter	Standard Deviation 0.23
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Pico (10^12) per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.01 Pico (10^12) per liter	Standard Deviation 0.43
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.09 Pico (10^12) per liter	Standard Deviation 0.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Pico (10^12) per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.06 Pico (10^12) per liter	Standard Deviation 0.18
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.06 Pico (10^12) per liter	Standard Deviation 0.42
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Pico (10^12) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.07 Pico (10^12) per liter	Standard Deviation 0.12
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Pico (10^12) per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.09 Pico (10^12) per liter	Standard Deviation 0.04

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.02
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.00 Percentage of BV occupied by RBCs	Standard Deviation 0.03
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	0.01 Percentage of BV occupied by RBCs	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.02 Percentage of BV occupied by RBCs	Standard Deviation 0.03
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.03
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Percentage of BV occupied by RBCs	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.00 Percentage of BV occupied by RBCs	Standard Deviation 0.03
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.02
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Percentage of BV occupied by RBCs	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.05
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.02 Percentage of BV occupied by RBCs	Standard Deviation 0.02
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Percentage of BV occupied by RBCs	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.01
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.02 Percentage of BV occupied by RBCs	Standard Deviation 0.04
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Percentage of BV occupied by RBCs	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.01 Percentage of BV occupied by RBCs	Standard Deviation 0.01
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Percentage of BV occupied by RBCs	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.02 Percentage of BV occupied by RBCs	Standard Deviation 0.01

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.1 Millimoles/liter	Standard Deviation 0.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.1 Millimoles/liter	Standard Deviation 0.5
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	0.10 Millimoles/liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.1 Millimoles/liter	Standard Deviation 0.7
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.3 Millimoles/liter	Standard Deviation 0.7
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Millimoles/liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.2 Millimoles/liter	Standard Deviation 0.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.0 Millimoles/liter	Standard Deviation 0.5
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Millimoles/liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	-0.3 Millimoles/liter	Standard Deviation 1.1
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.4 Millimoles/liter	Standard Deviation 0.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Millimoles/liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.0 Millimoles/liter	Standard Deviation 0.3
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	-0.1 Millimoles/liter	Standard Deviation 0.8
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Millimoles/liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24; n=8, 10, 7, 3, 4, 4	0.2 Millimoles/liter	Standard Deviation 0.2
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104; n=1, 0, 0, 0, 0, 0	NA Millimoles/liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48; n=8, 10, 7, 3, 3, 4	0.5 Millimoles/liter	Standard Deviation 0.3

Primary

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.

Time frame: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	-0.60 grams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	-0.07 grams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	-0.09 grams per liter	Standard Deviation 0.14
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.17 grams per liter	Standard Deviation 0.24
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	-0.23 grams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	-0.8 grams per liter	Standard Deviation 1.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	-0.6 grams per liter	Standard Deviation 1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	0.05 grams per liter	Standard Deviation 0.16
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	0.08 grams per liter	Standard Deviation 0.24
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.21 grams per liter	Standard Deviation 0.22
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	-0.1 grams per liter	Standard Deviation 0.8
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	-0.13 grams per liter	Standard Deviation 0.39
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	0.08 grams per liter	Standard Deviation 0.16
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	-0.03 grams per liter	Standard Deviation 0.39
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
300 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	0.5 grams per liter	Standard Deviation 1.6
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	1.2 grams per liter	Standard Deviation 1
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.18 grams per liter	Standard Deviation 0.24
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	0.13 grams per liter	Standard Deviation 0.11
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	-0.19 grams per liter	Standard Deviation 0.09
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	1.0 grams per liter	Standard Deviation 0.7
700 mg Ofa/Matching Placebo	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	0.40 grams per liter	Standard Deviation 0.4
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.24 grams per liter	Standard Deviation 0.24
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	-0.07 grams per liter	Standard Deviation 0.18
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	-0.5 grams per liter	Standard Deviation 1
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	0.25 grams per liter	Standard Deviation 0.25
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	-0.00 grams per liter	Standard Deviation 0.24
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	-0.6 grams per liter	Standard Deviation 1.2
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/100 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	0.2 grams per liter	Standard Deviation 1.6
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	0.05 grams per liter	Standard Deviation 0.21
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	-0.07 grams per liter	Standard Deviation 0.19
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	-0.3 grams per liter	Standard Deviation 0.9
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	0 grams per liter	Standard Deviation 0.44
Matching Placebo/300 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.40 grams per liter	Standard Deviation 0.17
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGA; n=8, 10, 6, 4, 4, 4	0.49 grams per liter	Standard Deviation 0.35
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGA; n=8, 11, 7, 4, 3, 4	0.29 grams per liter	Standard Deviation 0.26
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGM; n=8, 11, 7, 4, 3, 4	-0.13 grams per liter	Standard Deviation 0.04
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGM; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGG; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 104, IGA; n=1, 0, 0, 0, 0, 0	NA grams per liter	—
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGM; n=8, 10, 6, 4, 4, 4	0.04 grams per liter	Standard Deviation 0.08
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 48, IGG; n=8, 11, 7, 4, 3, 4	1.2 grams per liter	Standard Deviation 0.6
Matching Placebo/700 mg Ofa	Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)	Week 24, IGG; n=8, 10, 6, 4, 4, 4	1.4 grams per liter	Standard Deviation 0.9

Primary

Number of Participants With Abnormal Physical Examination Findings

The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis \[a brain and spinal cord disease\]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.

Time frame: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS

Arm	Measure	Group	Value (NUMBER)
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	1 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	1 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	1 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	1 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	1 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	1 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	1 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	1 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	1 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	1 participants
700 mg Ofa/Matching Placebo	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Acne vulgaris	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Venous varices on legs	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Venous varices on legs	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Obesitas	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Increased hearing loss	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Post operative scar	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Obesitas	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Anhidrotic eczema	1 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	IFUP; Any physical examination finding	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Vertebropathy	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 24-48; Vertebropathy	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Abnormal Physical Examination Findings	Week 0-24; Post operative scar	0 participants

Primary

Number of Participants With Any Adverse Event

An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period.

Time frame: First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.

Arm	Measure	Group	Value (NUMBER)
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 24-48	4 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 0-24	8 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 24-48	5 participants
300 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 0-24	10 participants
300 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 24-48	4 participants
700 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Weeks 0-24	7 participants
700 mg Ofa/Matching Placebo	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Any Adverse Event	Weeks 24-48	3 participants
Matching Placebo/100 mg Ofa	Number of Participants With Any Adverse Event	Weeks 0-24	3 participants
Matching Placebo/100 mg Ofa	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Any Adverse Event	Weeks 24-48	4 participants
Matching Placebo/300 mg Ofa	Number of Participants With Any Adverse Event	Weeks 0-24	2 participants
Matching Placebo/300 mg Ofa	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Any Adverse Event	Weeks 0-24	2 participants
Matching Placebo/700 mg Ofa	Number of Participants With Any Adverse Event	Individualized Follow-up Period	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With Any Adverse Event	Weeks 24-48	4 participants

Primary

Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)

Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.

Time frame: Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (NUMBER)
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	8 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	8 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	8 participants
300 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	8 participants
300 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	9 participants
300 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	11 participants
700 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	1 participants
700 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	2 participants
700 mg Ofa/Matching Placebo	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	7 participants
Matching Placebo/100 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	4 participants
Matching Placebo/100 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	4 participants
Matching Placebo/100 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	4 participants
Matching Placebo/100 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	4 participants
Matching Placebo/300 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	3 participants
Matching Placebo/300 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	3 participants
Matching Placebo/700 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 24; n=8, 9, 1, 4, 4, 4	4 participants
Matching Placebo/700 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 0; n=8, 8, 2, 4, 3, 4	4 participants
Matching Placebo/700 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4	3 participants
Matching Placebo/700 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4	1 participants
Matching Placebo/700 mg Ofa	Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)	IFUP, n=8, 11, 7, 4, 4, 4	0 participants

Primary

Number of Participants With the Indicated Critical Adverse Events (CAEs)

A CAE=treatment-related (TR) grade (G) \>=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.

Time frame: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS

Arm	Measure	Group	Value (NUMBER)
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	1 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	1 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	1 participants
300 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	0 participants
700 mg Ofa/Matching Placebo	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	1 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
Matching Placebo/100 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	0 participants
Matching Placebo/300 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Individualized Follow-up Period; any CAE	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Influenza	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Bronchospasm	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Cough	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 0-24; Rash pruritic	0 participants
Matching Placebo/700 mg Ofa	Number of Participants With the Indicated Critical Adverse Events (CAEs)	Week 24-48; any CAE	0 participants

Secondary

Clearance of Ofa Over the Course of Weeks 0-2 and 24-26

The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.

Time frame: Weeks 0-2 and 24-26

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	0.006 liters per hour	Geometric Coefficient of Variation 34.2
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters per hour	—
300 mg Ofa/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	0.005 liters per hour	Geometric Coefficient of Variation 41
300 mg Ofa/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters per hour	—
700 mg Ofa/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	0.003 liters per hour	Geometric Coefficient of Variation 30.8
700 mg Ofa/Matching Placebo	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters per hour	—
Matching Placebo/100 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters per hour	—
Matching Placebo/100 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	0.008 liters per hour	Geometric Coefficient of Variation 29.5
Matching Placebo/300 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters per hour	—
Matching Placebo/300 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	0.004 liters per hour	Geometric Coefficient of Variation 54.4
Matching Placebo/700 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters per hour	—
Matching Placebo/700 mg Ofa	Clearance of Ofa Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	0.03 liters per hour	Geometric Coefficient of Variation 44.4

Secondary

Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26

The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.

Time frame: Weeks 0-2 and 24-26

Population: FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	246 hours	Geometric Coefficient of Variation 16.1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA hours	—
300 mg Ofa/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	331 hours	Geometric Coefficient of Variation 35.2
300 mg Ofa/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA hours	—
700 mg Ofa/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	452 hours	Geometric Coefficient of Variation 28.4
700 mg Ofa/Matching Placebo	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA hours	—
Matching Placebo/100 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA hours	—
Matching Placebo/100 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	241 hours	Geometric Coefficient of Variation 23.6
Matching Placebo/300 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA hours	—
Matching Placebo/300 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	342 hours	Geometric Coefficient of Variation 16.3
Matching Placebo/700 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA hours	—
Matching Placebo/700 mg Ofa	Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	453 hours	Geometric Coefficient of Variation 49.9

Secondary

Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)

The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.

Time frame: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	0.0 lesions	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	0.13 lesions	Standard Deviation 0.35
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	0.0 lesions	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	0.25 lesions	Standard Deviation 0.71
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	0.0 lesions	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	0 lesions	Standard Deviation 0
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0.13 lesions	Standard Deviation 0.35
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	0.0 lesions	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	0.13 lesions	Standard Deviation 0.35
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	0.13 lesions	Standard Deviation 0.35
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0.13 lesions	Standard Deviation 0.35
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0 lesions	Standard Deviation 0
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	0.09 lesions	Standard Deviation 0.3
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	0.27 lesions	Standard Deviation 0.47
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	0 lesions	Standard Deviation 0
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	NA lesions	—
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	0.09 lesions	Standard Deviation 0.3
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
300 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	NA lesions	—
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	NA lesions	—
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	0 lesions	Standard Deviation 0
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	0.29 lesions	Standard Deviation 0.49
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	NA lesions	—
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0.29 lesions	Standard Deviation 0.76
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0.29 lesions	Standard Deviation 0.76
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	0 lesions	Standard Deviation 0
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	0 lesions	Standard Deviation 0
700 mg Ofa/Matching Placebo	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	0.43 lesions	Standard Deviation 1.13
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	3.06 lesions	Standard Deviation 4.66
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	3.63 lesions	Standard Deviation 5.02
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	4.00 lesions	Standard Deviation 6.52
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	1.50 lesions	Standard Deviation 3
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0 lesions	Standard Deviation 0
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	NA lesions	—
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	NA lesions	—
Matching Placebo/100 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0.33 lesions	Standard Deviation 0.58
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	25.00 lesions	Standard Deviation 46.03
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	23.50 lesions	Standard Deviation 43
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	NA lesions	—
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	5.00 lesions	Standard Deviation 9.35
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	25.75 lesions	Standard Deviation 46.23
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	NA lesions	—
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0.33 lesions	Standard Deviation 0.58
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	3.00 lesions	Standard Deviation 4.36
Matching Placebo/300 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	3.00 lesions	Standard Deviation 5.2
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4	0.25 lesions	Standard Deviation 0.5
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0	NA lesions	—
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0	NA lesions	—
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4	3.00 lesions	Standard Deviation 4.24
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4	4.50 lesions	Standard Deviation 7.14
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0	NA lesions	—
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4	2.50 lesions	Standard Deviation 3.32
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4	0 lesions	Standard Deviation 0
Matching Placebo/700 mg Ofa	Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)	Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4	0 lesions	Standard Deviation 0

Secondary

Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions

The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.

Time frame: Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	32.3 milligrams per liter	Standard Deviation 9.65
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	23.4 milligrams per liter	Standard Deviation 19.9
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
300 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
300 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	64.9 milligrams per liter	Standard Deviation 67.1
300 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	85.8 milligrams per liter	Standard Deviation 53.7
300 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	174 milligrams per liter	Standard Deviation 187
700 mg Ofa/Matching Placebo	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	176 milligrams per liter	Standard Deviation 24.2
Matching Placebo/100 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/100 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	21.6 milligrams per liter	Standard Deviation 18.5
Matching Placebo/100 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/100 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	28.9 milligrams per liter	Standard Deviation 8.03
Matching Placebo/300 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	43.4 milligrams per liter	Standard Deviation 67.9
Matching Placebo/300 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	47.7 milligrams per liter	Standard Deviation 76.9
Matching Placebo/300 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/300 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/700 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/700 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 24; n=0, 0, 0, 4, 3, 4	72.7 milligrams per liter	Standard Deviation 128
Matching Placebo/700 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 26; n=0, 0, 0, 4, 3, 4	82.4 milligrams per liter	Standard Deviation 144
Matching Placebo/700 mg Ofa	Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—

Secondary

The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	153 Millgram hour per liter	Geometric Coefficient of Variation 19.4
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	15559 Millgram hour per liter	Geometric Coefficient of Variation 34.4
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
300 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
300 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	63165 Millgram hour per liter	Geometric Coefficient of Variation 40.6
300 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	498 Millgram hour per liter	Geometric Coefficient of Variation 18.6
300 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
700 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
700 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA Millgram hour per liter	—
700 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	225876 Millgram hour per liter	Geometric Coefficient of Variation 30.4
700 mg Ofa/Matching Placebo	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	1528 Millgram hour per liter	Geometric Coefficient of Variation 20.7
Matching Placebo/100 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—
Matching Placebo/100 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	12763 Millgram hour per liter	Geometric Coefficient of Variation 29.3
Matching Placebo/100 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—
Matching Placebo/100 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	123 Millgram hour per liter	Geometric Coefficient of Variation 8.6
Matching Placebo/300 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	624 Millgram hour per liter	Geometric Coefficient of Variation 32.7
Matching Placebo/300 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	71041 Millgram hour per liter	Geometric Coefficient of Variation 54.9
Matching Placebo/300 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—
Matching Placebo/300 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—
Matching Placebo/700 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—
Matching Placebo/700 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	1347 Millgram hour per liter	Geometric Coefficient of Variation 29.1
Matching Placebo/700 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	217757 Millgram hour per liter	Geometric Coefficient of Variation 44.5
Matching Placebo/700 mg Ofa	The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA Millgram hour per liter	—

Secondary

The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).

Time frame: Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	36.8 milligrams per liter	Geometric Coefficient of Variation 13.1
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	47.7 milligrams per liter	Geometric Coefficient of Variation 14.7
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
300 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
300 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	157 milligrams per liter	Geometric Coefficient of Variation 25.9
300 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	124 milligrams per liter	Geometric Coefficient of Variation 23.6
300 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA milligrams per liter	—
700 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	452 milligrams per liter	Geometric Coefficient of Variation 28.5
700 mg Ofa/Matching Placebo	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	346 milligrams per liter	Geometric Coefficient of Variation 24
Matching Placebo/100 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/100 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	43.5 milligrams per liter	Geometric Coefficient of Variation 25.2
Matching Placebo/100 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/100 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	33.2 milligrams per liter	Geometric Coefficient of Variation 13.7
Matching Placebo/300 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	137 milligrams per liter	Geometric Coefficient of Variation 40.7
Matching Placebo/300 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	210 milligrams per liter	Geometric Coefficient of Variation 54.1
Matching Placebo/300 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/300 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/700 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—
Matching Placebo/700 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	312 milligrams per liter	Geometric Coefficient of Variation 24.5
Matching Placebo/700 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	416 milligrams per liter	Geometric Coefficient of Variation 24.6
Matching Placebo/700 mg Ofa	The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA milligrams per liter	—

Secondary

The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26

The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.

Time frame: Weeks 0-2 and 24-26

Population: FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	2.48 liters	Geometric Coefficient of Variation 20.4
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters	—
300 mg Ofa/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	2.61 liters	Geometric Coefficient of Variation 42
300 mg Ofa/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters	—
700 mg Ofa/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	2.19 liters	Geometric Coefficient of Variation 21.3
700 mg Ofa/Matching Placebo	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	NA liters	—
Matching Placebo/100 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters	—
Matching Placebo/100 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	2.74 liters	Geometric Coefficient of Variation 6.54
Matching Placebo/300 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters	—
Matching Placebo/300 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	2.20 liters	Geometric Coefficient of Variation 68
Matching Placebo/700 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 0-2; n=8, 10, 6, 0, 0, 0	NA liters	—
Matching Placebo/700 mg Ofa	The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26	Weeks 24-26; n=0, 0, 0, 4, 3, 4	2.15 liters	Geometric Coefficient of Variation 20.8

Secondary

Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

The peripheral blood for each participant was collected and analyzed for tmax.

Time frame: Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEDIAN)
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	5.33 hours
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	4.25 hours
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA hours
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA hours
300 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA hours
300 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	4.33 hours
300 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	5.88 hours
300 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA hours
700 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	NA hours
700 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	NA hours
700 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	3.83 hours
700 mg Ofa/Matching Placebo	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	6.00 hours
Matching Placebo/100 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA hours
Matching Placebo/100 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	3.67 hours
Matching Placebo/100 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA hours
Matching Placebo/100 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	4.42 hours
Matching Placebo/300 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	6.00 hours
Matching Placebo/300 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	5.17 hours
Matching Placebo/300 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA hours
Matching Placebo/300 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA hours
Matching Placebo/700 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 2; n=8, 10, 6, 0, 0, 0	NA hours
Matching Placebo/700 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 24; n=0, 0, 0, 4, 3, 4	6.54 hours
Matching Placebo/700 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 26; n=0, 0, 0, 4, 3, 4	4.50 hours
Matching Placebo/700 mg Ofa	Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions	Week 0; n=8, 10, 6, 0, 0, 0	NA hours

Secondary

Total Volume of T2 Lesions at Week 24 and Week 48

The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.

Time frame: Visit 10 (Week 24) and Visit 17 (Week 48)

Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	7898 millimeters cubed	Standard Deviation 8802
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	7791 millimeters cubed	Standard Deviation 8878
300 mg Ofa/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	10323 millimeters cubed	Standard Deviation 8281
300 mg Ofa/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	11304 millimeters cubed	Standard Deviation 8269
700 mg Ofa/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	17399 millimeters cubed	Standard Deviation 11641
700 mg Ofa/Matching Placebo	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	17566 millimeters cubed	Standard Deviation 12413
Matching Placebo/100 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	11290 millimeters cubed	Standard Deviation 11746
Matching Placebo/100 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	10684 millimeters cubed	Standard Deviation 8903
Matching Placebo/300 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	12194 millimeters cubed	Standard Deviation 18008
Matching Placebo/300 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	18164 millimeters cubed	Standard Deviation 23696
Matching Placebo/700 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 24; n=8, 11, 7, 3, 4, 4	15039 millimeters cubed	Standard Deviation 8984
Matching Placebo/700 mg Ofa	Total Volume of T2 Lesions at Week 24 and Week 48	Week 48; n=8, 10, 7, 4, 3, 4	15166 millimeters cubed	Standard Deviation 9060

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)

Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)

Number of Participants With Abnormal Physical Examination Findings

Number of Participants With Any Adverse Event

Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)

Number of Participants With the Indicated Critical Adverse Events (CAEs)

Clearance of Ofa Over the Course of Weeks 0-2 and 24-26

Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26

Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)

Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions

The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26

Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions

Total Volume of T2 Lesions at Week 24 and Week 48