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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00603525
• Collaborator: (none)
• Enrollment: 169
• Locations: 60
• Arms: 2
• Duration (Months): 66
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: Ofatumumab; Drug: Placebo	Phase 3

Detailed Description

This study consist of a double-blind, placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive either ofatumumab or placebo in addition to their background methotrexate treatment. Patients who complete the 24 week Double-blind Period without receiving rescue DMARD treatment will then be eligible to proceed into the 120 week Open-label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity.

Patients who have completed the Open-label Period or have been withdrawn will then enter a maximum 2 year Follow-up Period, or until there B-cells return to normal or to baseline levels, whichever occurs earlier

Study Design

• Study Type: Interventional
• Actual Enrollment: 169 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ofatumumab 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each treatment cycle consisting of two IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period	Drug: Ofatumumab; 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each treatment cycle consisting of two IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period
Placebo Comparator: 1000 ml Saline 1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period	Drug: Placebo; 1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

   The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.

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

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

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

   The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.

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

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

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

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

10. Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24 [Weeks 4, 8, 12, 16, 20, and 24]

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

11. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 [Weeks 4, 8, 12, 16, 20, and 24]

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

12. Change From Baseline in Tender Joint Count at Week 24 [Baseline and Week 24]

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

13. Change From Baseline in Swollen Joint Count at Week 24 [Baseline and Week 24]

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

14. Change From Baseline in CRP at Week 24 [Baseline and Week 24]

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

15. Change From Baseline in ESR at Week 24 [Baseline and Week 24]

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

16. Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24 [Baseline and Week 24]

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

17. Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24 [Baseline and Week 24]

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

18. Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24 [Baseline and Week 24]

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

19. Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24 [Baseline and Week 24]

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

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

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

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

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

22. Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 [Baseline and Week 4]

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

23. Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24 [Baseline and Week 24]

    Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.

24. Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 [Baseline, Week 12, and Week 24]

    The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.

25. Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

26. Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

27. Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

28. Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

29. Time to Retreatment, by Ofatumumab Treatment Course [From Baseline up to Week 144]

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

30. Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

31. Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course [First 24 weeks of each treatment course (assessed up to Week 144)]

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

32. Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course [First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144]

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

33. Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period [From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144]

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

34. Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

35. Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

36. Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

37. Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

38. Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

39. Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

    Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.

40. Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

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

41. Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course [From baseline up to Week 144]

    The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.

42. Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods [From basline up to Week 144]

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

43. Number of Participants With Any Serious Adverse Event During the Follow-up Period [From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])]

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

44. Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period [From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)]

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

45. Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab [From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)]

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

46. Number of Participants With a Positive JC Virus Test Result During the Follow-up Period [From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)]

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

47. Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period [From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)]

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

48. Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period [From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years;

• Active disease at the time of screening as defined by:

≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);

• Inadequate response to previous or current TNF-alpha antagonist treatment;

• Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion Criteria:

• Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA;

• Previous exposure to biologic anti-rheumatic therapies, including investigational compounds;

• Exposure to TNF-alpha antagonist treatment < 12 weeks prior to visit 2;

• Chronic or ongoing active infectious disease requiring systemic treatment;

• Clinically significant cardiac disease; History of significant cerebrovascular disease;

• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease;

• Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR;

• Serum IgG < lower limit of normal;

• Breast feeding women or women with a positive pregnancy test at screening;

• Current participation in any other interventional clinical study;

• Patients known or suspected of not being able to comply with a study protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	AAL1426
2	GSK Investigational Site	Rosario	Santa Fe	Argentina	2000
3	GSK Investigational Site	Cordoba		Argentina	5000
4	GSK Investigational Site	Tucuman		Argentina	4000
5	GSK Investigational Site	Herlev		Denmark	2730
6	GSK Investigational Site	Silkeborg		Denmark	8600
7	GSK Investigational Site	Amiens	Picardie	France	80054
8	GSK Investigational Site	Cahors cedex 9		France	46005
9	GSK Investigational Site	Corbeil Essonnes Cedex		France	91106
10	GSK Investigational Site	Echirolles		France	38434
11	GSK Investigational Site	Strasbourg		France	67098
12	GSK Investigational Site	Toulouse		France	31059
13	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69120
14	GSK Investigational Site	Erlangen	Bayern	Germany	91054
15	GSK Investigational Site	Potsdam	Brandenburg	Germany	14467
16	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
17	GSK Investigational Site	Osnabrueck	Niedersachsen	Germany	49074
18	GSK Investigational Site	Magdeburg	Sachsen-Anhalt	Germany	39112
19	GSK Investigational Site	Leipzg	Sachsen	Germany	04109
20	GSK Investigational Site	Berlin		Germany	10559
21	GSK Investigational Site	Berlin		Germany	14129
22	GSK Investigational Site	Hamburg		Germany	22081
23	GSK Investigational Site	Hamburg		Germany	22415
24	GSK Investigational Site	Napoli	Campania	Italy	80131
25	GSK Investigational Site	Telese Terme (BN)	Campania	Italy	82100
26	GSK Investigational Site	Roma	Lazio	Italy	00161
27	GSK Investigational Site	Genova	Liguria	Italy	16132
28	GSK Investigational Site	Milano	Lombardia	Italy	20132
29	GSK Investigational Site	Milano	Lombardia	Italy	20157
30	GSK Investigational Site	Milano	Lombardia	Italy	20162
31	GSK Investigational Site	Varese	Lombardia	Italy	21100
32	GSK Investigational Site	Prato	Toscana	Italy	59100
33	GSK Investigational Site	Padova	Veneto	Italy	35121
34	GSK Investigational Site	Incheon		Korea, Republic of	400-711
35	GSK Investigational Site	Seoul		Korea, Republic of	110-744
36	GSK Investigational Site	Seoul		Korea, Republic of	120-752
37	GSK Investigational Site	Seoul		Korea, Republic of	133-792
38	GSK Investigational Site	Seoul		Korea, Republic of	137-701
39	GSK Investigational Site	Amsterdam		Netherlands	1056 AB
40	GSK Investigational Site	Enschede		Netherlands	7511JX
41	GSK Investigational Site	Zwolle		Netherlands	8011 JW
42	GSK Investigational Site	Haugesund		Norway	N-5528
43	GSK Investigational Site	Levanger		Norway	7600
44	GSK Investigational Site	Lillehammer		Norway	2609
45	GSK Investigational Site	Trondheim		Norway	7006
46	GSK Investigational Site	Lima		Peru	Lima 27
47	GSK Investigational Site	Getafe/Madrid		Spain	28905
48	GSK Investigational Site	Madrid		Spain	28007
49	GSK Investigational Site	Madrid		Spain	28046
50	GSK Investigational Site	Mérida (Badajoz)		Spain	06800
51	GSK Investigational Site	Santander		Spain	39008
52	GSK Investigational Site	Sevilla		Spain	41071
53	GSK Investigational Site	Valencia		Spain	46017
54	GSK Investigational Site	Oskarström		Sweden	SE-313 92
55	GSK Investigational Site	Stockholm		Sweden	SE-171 76
56	GSK Investigational Site	Wishaw	Lanarkshire	United Kingdom	ML2 0DP
57	GSK Investigational Site	Newcastle	Northumberland	United Kingdom	NE1 4LP
58	GSK Investigational Site	Cannock		United Kingdom	WS11 5XY
59	GSK Investigational Site	Dundee		United Kingdom	DD1 9SY
60	GSK Investigational Site	Leytonstone, London		United Kingdom	E11 1NR

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00603525
• Other Study ID Numbers: 110634; GEN411
• First Posted: Jan 29, 2008
• Last Update Posted: Jun 9, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Ofatumumab

Study Results

Participant Flow

Pre-assignment Detail	Study OFA110634 is comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who complete the OL Period, or who are withdrawn, enter a Follow-up (FU) period (anticipated to be approximately 2 years).

Arm/Group Title	Placebo	Ofatumumab	Placebo or OFA 700 mg: FU Period
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).	Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
Period Title: DB Treatment Period (24 Weeks)
STARTED	84	85	0
COMPLETED	67	63	0
NOT COMPLETED	17	22	0
Period Title: DB Treatment Period (24 Weeks)
STARTED	0	125	0
COMPLETED	0	13	0
NOT COMPLETED	0	112	0
Period Title: DB Treatment Period (24 Weeks)
STARTED	0	0	124
Unknown Reason for Withdrawal	0	0	111
COMPLETED	0	0	13
NOT COMPLETED	0	0	111

Baseline Characteristics

Arm/Group Title	Placebo	Ofatumumab 700 mg	Total
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Total of all reporting groups
Overall Participants	84	85	169
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.3 (11.69)	53.7 (13.64)	53.5 (12.67)
Sex: Female, Male (Count of Participants)
Female	67 79.8%	73 85.9%	140 82.8%
Male	17 20.2%	12 14.1%	29 17.2%
Race/Ethnicity, Customized (participants) [Number]
Hispanic/Latino	35 41.7%	35 41.2%	70 41.4%
Not Hispanic/Latino	49 58.3%	50 58.8%	99 58.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Number [participants]	16 19%	36 42.4%

2. Secondary Outcome

Title	Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20
Description	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame	Baseline and Weeks 4, 8, 12, 16, and 20

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Week 4	22 26.2%	25 29.4%
Week 8	23 27.4%	29 34.1%
Week 12	30 35.7%	36 42.4%
Week 16	23 27.4%	36 42.4%
Week 20	21 25%	40 47.1%

3. Secondary Outcome

Title	Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24
Description	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Week 4	9 10.7%	4 4.7%
Week 8	8 9.5%	9 10.6%
Week 12	11 13.1%	17 20%
Week 16	10 11.9%	17 20%
Week 20	8 9.5%	18 21.2%
Week 24	5 6%	19 22.4%

4. Secondary Outcome

Title	Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24
Description	The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Week 4	3 3.6%	0 0%
Week 8	2 2.4%	3 3.5%
Week 12	3 3.6%	5 5.9%
Week 16	3 3.6%	5 5.9%
Week 20	3 3.6%	5 5.9%
Week 24	3 3.6%	6 7.1%

5. Secondary Outcome

Title	Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	80	73
Week 4, n=80, 73	5.00 (1.492)	5.02 (1.361)
Week 8, n=74, 73	4.96 (1.352)	4.60 (1.300)
Week 12, n=73, 71	4.86 (1.537)	4.16 (1.194)
Week 16, n=69, 71	4.88 (1.526)	4.17 (1.273)
Week 20, n=67, 68	4.91 (1.505)	4.04 (1.262)
Week 24, n=68, 67	5.21 (1.324)	4.22 (1.432)

6. Secondary Outcome

Title	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	80	73
Week 4, n=80, 73	-0.83 (1.237)	-0.89 (1.094)
Week 8, n=74, 73	-0.81 (1.127)	-1.22 (1.142)
Week 12, n=73, 71	-0.92 (1.382)	-1.64 (1.242)
Week 16, n=69, 71	-0.86 (1.362)	-1.64 (1.318)
Week 20, n=67, 68	-0.79 (1.270)	-1.75 (1.311)
Week 24, n=68, 67	-0.51 (1.142)	-1.56 (1.370)

7. Secondary Outcome

Title	Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	80	74
Week 4, n=80, 74	5.84 (1.455)	5.80 (1.390)
Week 8, n=74, 72	5.76 (1.327)	5.41 (1.335)
Week 12, n=73, 71	5.60 (1.498)	4.99 (1.269)
Week 16, n=69, 71	5.66 (1.481)	4.95 (1.356)
Week 20, n=67, 68	5.74 (1.539)	4.79 (1.312)
Week 24, n=68, 67	5.96 (1.358)	5.03 (1.537)

8. Secondary Outcome

Title	Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	80	74
Week 4, n=80, 74	-0.85 (1.210)	-0.98 (1.105)
Week 8, n=74, 72	-0.88 (1.117)	-1.28 (1.165)
Week 12, n=73, 71	-1.05 (1.332)	-1.70 (1.304)
Week 16, n=69, 71	-0.95 (1.353)	-1.75 (1.350)
Week 20, n=67, 68	-0.85 (1.299)	-1.89 (1.299)
Week 24, n=68, 67	-0.63 (1.211)	-1.64 (1.473)

9. Secondary Outcome

Title	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant
Description	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Week 4, Good	15 17.9%	8 9.4%
Week 4, Moderate	18 21.4%	25 29.4%
Week 4, None	47 56%	40 47.1%
Week 8, Good	11 13.1%	11 12.9%
Week 8, Moderate	23 27.4%	31 36.5%
Week 8, None	40 47.6%	31 36.5%
Week 12, Good	13 15.5%	14 16.5%
Week 12, Moderate	22 26.2%	39 45.9%
Week 12, None	38 45.2%	18 21.2%
Week 16, Good	9 10.7%	17 20%
Week 16, Moderate	23 27.4%	33 38.8%
Week 16, None	37 44%	21 24.7%
Week 20, Good	10 11.9%	18 21.2%
Week 20, Moderate	21 25%	32 37.6%
Week 20, None	36 42.9%	18 21.2%
Week 24, Good	6 7.1%	15 17.6%
Week 24, Moderate	19 22.6%	29 34.1%
Week 24, None	43 51.2%	23 27.1%

10. Secondary Outcome

Title	Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant
Description	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.
Time Frame	Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	84	85
Week 4, Good	3 3.6%	4 4.7%
Week 4, Moderate	29 34.5%	21 24.7%
Week 4, None	48 57.1%	49 57.6%
Week 8, Good	2 2.4%	5 5.9%
Week 8, Moderate	28 33.3%	33 38.8%
Week 8, None	44 52.4%	34 40%
Week 12, Good	2 2.4%	7 8.2%
Week 12, Moderate	36 42.9%	41 48.2%
Week 12, None	35 41.7%	23 27.1%
Week 16, Good	3 3.6%	6 7.1%
Week 16, Moderate	29 34.5%	43 50.6%
Week 16, None	37 44%	22 25.9%
Week 20, Good	1 1.2%	5 5.9%
Week 20, Moderate	27 32.1%	46 54.1%
Week 20, None	39 46.4%	17 20%
Week 24, Good	2 2.4%	6 7.1%
Week 24, Moderate	20 23.8%	37 43.5%
Week 24, None	46 54.8%	24 28.2%

11. Secondary Outcome

Title	Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24
Description	ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

12. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24
Description	The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.
Time Frame	Weeks 4, 8, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	75	72
Week 4, n=75, 72	-0.13	-0.13
Week 8, n=69, 68	-0.25	-0.38
Week 12, n=68, 65	-0.13	-0.38
Week 16, n=65, 64	-0.13	-0.38
Week 20, n=64, 64	-0.13	-0.38
Week 24, n=63, 61	0.00	-0.38

13. Secondary Outcome

Title	Change From Baseline in Tender Joint Count at Week 24
Description	Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	68	66
Median (Full Range) [tender joints]	-5	-11

14. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count at Week 24
Description	Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	68	66
Median (Full Range) [swollen joints]	-3.50	-7.50

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	66	66
Median (Full Range) [milligrams per liter (mg/L)]	1.05	-2.85

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	67	67
Median (Full Range) [millimeters per hour (mm/hr)]	0.00	-12.00

17. Secondary Outcome

Title	Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24
Description	A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the "no pain" end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

18. Secondary Outcome

Title	Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24
Description	The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

19. Secondary Outcome

Title	Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24
Description	The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

20. Secondary Outcome

Title	Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24
Description	The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating "Not at all fatigued," to 4, indicating "Very much fatigued."
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

21. Secondary Outcome

Title	Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24
Description	The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

22. Secondary Outcome

Title	Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24
Description	The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

23. Secondary Outcome

Title	Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4
Description	The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants contributing values at the relevant visit were analyzed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	81	82
Anti-CCP, Baseline, n=81, 82	466	449.5
RF-IgA, Baseline, n=81, 81	9	11
RF-IgA, Week 4, n=0, 1	NA	100
IgG, Baseline, n=81, 81	5	2.5
IgG, Week4, n=0, 1	NA	5
RF-IgM, Baseline, n=81, 81	92	68
RF-IgM, Week 4, n=0, 1	NA	43

24. Secondary Outcome

Title	Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24
Description	Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

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

25. Secondary Outcome

Title	Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24
Description	The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.
Time Frame	Baseline, Week 12, and Week 24

Outcome Measure Data

Analysis Population Description

Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.

Arm/Group Title	Placebo	Ofatumumab 700 mg
Arm/Group Description	Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).	Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Measure Participants	79	75
IgA, Week 12; n=79, 75	-0.020	-0.250
IgA, Week 24; n=69, 68	0.050	-0.350
IgG, Week 12; n=79, 75	-0.400	-1.300
IgG, Week 24; n=69, 68	-0.700	-1.615
IgM, Week 12; n=79, 75	-0.040	-0.260
IgM, Week 24; n=69, 68	-0.050	-0.355

26. Secondary Outcome

Title	Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	148	0
TC 1, n=0, 148, 0	4.64 (1.511)
TC 2, n=0, 92, 0	4.08 (1.129)
TC 3, n=0, 62, 0	4.09 (1.346)
TC 4, n=0, 29, 0	3.84 (1.437)
TC 5, n=0, 13, 0	3.95 (1.327)
TC 6, n=0, 6, 0	3.33 (1.245)

27. Secondary Outcome

Title	Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

AT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	147	0
TC 1, n=0, 147, 0	3.86 (1.443)
TC 2, n=0, 92, 0	3.37 (1.120)
TC 3, n=0, 62, 0	3.35 (1.181)
TC 4, n=0, 29, 0	3.15 (1.214)
TC 5, n=0, 13, 0	3.23 (1.129)
TC 6, n=0, 6, 0	2.84 (1.193)

28. Secondary Outcome

Title	Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	134	0
TC 1, n=0, 134, 0	-2.04 (1.348)
TC 2, n=0, 90, 0	-1.70 (1.090)
TC 3, n=0, 59, 0	-1.52 (1.052)
TC 4, n=0, 28, 0	-1.76 (1.499)
TC 5, n=0, 12, 0	-1.50 (1.052)
TC 6, n=0, 6, 0	-2.39 (0.581)

29. Secondary Outcome

Title	Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	134	0
TC 1, n=0, 134, 0	-1.93 (1.297)
TC 2, n=0, 92, 0	-1.65 (1.086)
TC 3, n=0, 61, 0	-1.44 (1.006)
TC 4, n=0, 28, 0	-1.65 (1.378)
TC 5, n=0, 12, 0	-1.46 (1.006)
TC 6, n=0, 6, 0	-2.20 (0.610)

30. Secondary Outcome

Title	Time to Retreatment, by Ofatumumab Treatment Course
Description	Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.
Time Frame	From Baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	93	0
TC 1, n=0, 93, 0	32.79 (12.031)
TC 2, n=0, 63, 0	28.62 (11.108)
TC 3, n=0, 30, 0	24.56 (8.127)
TC 4, n=0, 13, 0	23.93 (6.143)
TC 5, n=0, 6, 0	19.07 (2.795)
TC 6, n=0, 0, 0	NA (NA)

31. Secondary Outcome

Title	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

AT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	148	0
TC 1, Remission, n=0, 148, 0	15 17.9%
TC 1, Low Disease Activity, n=0, 148	7 8.3%
TC 2, Remission, n=0, 93, 0	5 6%
TC 2, Low Disease Activity, n=0, 93, 0	20 23.8%
TC 3, Remission, n=0, 63, 0	8 9.5%
TC 3, Low Disease Activity, n=0, 63, 0	8 9.5%
TC 4, Remission, n=0, 30, 0	6 7.1%
TC 4, Low Disease Activity, n=0, 30, 0	5 6%
TC 5, Remission, n=0, 13, 0	2 2.4%
TC 5, Low Disease Activity, n=0, 13, 0	2 2.4%
TC 6, Remission, n=0, 6, 0	2 2.4%
TC 6, Low Disease Activity, n=0, 6, 0	2 2.4%

32. Secondary Outcome

Title	Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.
Time Frame	First 24 weeks of each treatment course (assessed up to Week 144)

Outcome Measure Data

Analysis Population Description

AT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	148	0
TC 1, Remission, n=0, 148, 0	27 32.1%
TC 1, Low Disease Activity, n=0, 148, 0	26 31%
TC 2, Remission, n=0, 93, 0	24 28.6%
TC 2, Low Disease Activity, n=0, 93, 0	17 20.2%
TC 3, Remission, n=0, 63, 0	19 22.6%
TC 3, Low Disease Activity, n=0, 63, 0	10 11.9%
TC 4, Remission, n=0, 30, 0	10 11.9%
TC 4, Low Disease Activity, n=0, 30, 0	5 6%
TC 5, Remission,n=0, 13, 0	5 6%
TC 5, Low Disease Activity,n=0, 13, 0	1 1.2%
TC 6, Remission,n=0, 6, 0	3 3.6%
TC 6, Low Disease Activity,n=0, 6, 0	2 2.4%

33. Secondary Outcome

Title	Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.
Time Frame	First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144

Outcome Measure Data

Analysis Population Description

AT Population

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	148	0
Any AE, TC 1, n=0, 148, 0	126 150%
Any AE, TC 2, n=0, 93, 0	60 71.4%
Any AE, TC 3, n=0, 63, 0	36 42.9%
Any AE, TC 4, n=0, 30, 0	17 20.2%
Any AE, TC 5, n=0, 13, 0	8 9.5%
Any AE, TC 6, n=0, 6, 0	5 6%
Any SAE, TC 1, n=0, 148, 0	20 23.8%
Any SAE, TC 2, n=0, 93, 0	10 11.9%
Any SAE, TC 3, n=0, 63, 0	2 2.4%
Any SAE, TC 4, n=0, 30, 0	0 0%
Any SAE, TC 5, n=0, 13, 0	0 0%
Any SAE, TC 6, n=0, 6, 0	0 0%

34. Secondary Outcome

Title	Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period
Description	The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.
Time Frame	From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	117	0
Week 48, normal, n=0, 117, 0	81 96.4%
Week 48, abnormal CS, n=0, 117, 0	0 0%
Week 48, abnormal NCS, n=0, 117, 0	34 40.5%
Week 48, NR, n=0, 117, 0	2 2.4%
Week 72, normal, n=0, 87, 0	59 70.2%
Week 72, abnormal CS, n=0, 87, 0	0 0%
Week 72, abnormal NCS, n=0, 87, 0	25 29.8%
Week 72, NR, n=0, 87, 0	3 3.6%
Week 96, normal, n=0, 57, 0	40 47.6%
Week 96, abnormal CS, n=0, 57, 0	0 0%
Week 96, abnormal NCS, n=0, 57, 0	16 19%
Week 96, NR, n=0, 57, 0	1 1.2%
Week 120, normal, n=0, 33, 0	16 19%
Week 120, abnormal CS, n=0, 33, 0	0 0%
Week 120, abnormal NCS, n=0, 33, 0	17 20.2%
Week 120, NR, n=0, 33, 0	0 0%
Week 144, normal, n=0, 17, 0	10 11.9%
Week 144, abnormal CS, n=0, 17, 0	0 0%
Week 144, abnormal NCS, n=0, 17, 0	7 8.3%
Week 144, NR, n=0, 17, 0	0 0%

35. Secondary Outcome

Title	Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	136	0
TC 1, Week 8, n=0, 136, 0	0 0%
TC 1, Week 16, n=0, 100, 0	0 0%
TC 1, Week 24, n=0, 99, 0	2 2.4%
TC 1, Week 32, n=0, 50, 0	1 1.2%
TC 1, Week 40, n=0, 30, 0	3 3.6%
TC 1, Week 48, n=0, 23, 0	1 1.2%
TC 1, Week 56, n=0, 14, 0	3 3.6%
TC 1, Week 64, n=0, 7, 0	1 1.2%
TC 1, Week 72, n=0, 4, 0	0 0%
TC 1, Week 80, n=0, 1, 0	0 0%
TC 1, Week 88, n=0, 1, 0	0 0%
TC 1, Week 96, n=0, 1, 0	0 0%
TC 1, Week 104, n=0, 2, 0	1 1.2%
TC 1, Week 112, n=0, 1, 0	0 0%
TC 1, Week 120, n=0, 1, 0	0 0%
TC 1, Week 128, n=0, 1, 0	0 0%
TC 1, Week 144, n=0, 1, 0	0 0%
TC 2, Week 8, n=0, 93, 0	0 0%
TC 2, Week 16, n=0, 80, 0	1 1.2%
TC 2, Week 24, n=0, 70, 0	0 0%
TC 2, Week 32, n=0, 31, 0	2 2.4%
TC 2, Week 40, n=0, 20, 0	2 2.4%
TC 2, Week 48, n=0, 11, 0	1 1.2%
TC 2, Week 56, n=0, 8, 0	0 0%
TC 2, Week 64, n=0, 6, 0	1 1.2%
TC 2, Week 72, n=0, 2, 0	0 0%
TC 2, Week 80, n=0, 2, 0	0 0%
TC 2, Week 96, n=0, 1, 0	0 0%
TC 3, Week 8, n=0, 60, 0	0 0%
TC 3, Week 16, n=0, 45, 0	0 0%
TC 3, Week 24, n=0, 29, 0	0 0%
TC 3, Week 32, n=0, 12, 0	1 1.2%
TC 3, Week 40, n=0, 4, 0	0 0%
TC 3, Week 48, n=0, 2, 0	1 1.2%
TC 3, Week 56, n=0, 1, 0	1 1.2%
TC 4, Week 8, n=0, 29, 0	0 0%
TC 4, Week 16, n=0, 24, 0	0 0%
TC 4, Week 24, n=0, 13, 0	0 0%
TC 4, Week 32, n=0, 4, 0	0 0%
TC 4, Week 40, n=0, 1, 0	0 0%
TC 4, Week 48, n=0, 1, 0	0 0%
TC 5, Week 8, n=0, 13, 0	0 0%
TC 5, Week 16, n=0, 8, 0	0 0%
TC 5, Week 24, n=0, 5, 0	0 0%
TC 5, Week 32, n=0, 5, 0	0 0%
TC 5, Week 40, n=0, 1, 0	0 0%
TC 6, Week 8, n=0, 6, 0	0 0%
TC 6, Week 16, n=0, 6, 0	0 0%
TC 6, Week 24, n=0, 5, 0	0 0%
TC 6, Week 32, n=0, 3, 0	0 0%

36. Secondary Outcome

Title	Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	136	0
TC 1, Week 8, n=0, 136, 0	115 136.9%
TC 1, Week 16, n=0, 100, 0	79 94%
TC 1, Week 24, n=0, 99, 0	75 89.3%
TC 1, Week 32, n=0, 50, 0	44 52.4%
TC 1, Week 40, n=0, 30, 0	27 32.1%
TC 1, Week 48, n=0, 23, 0	21 25%
TC 1, Week 56, n=0, 14, 0	11 13.1%
TC 1, Week 64, n=0, 7, 0	7 8.3%
TC 1, Week 72, n=0, 4, 0	4 4.8%
TC 1, Week 80, n=0, 1, 0	1 1.2%
TC 1, Week 88, n=0, 1, 0	1 1.2%
TC 1, Week 96, n=0, 1, 0	1 1.2%
TC 1, Week 104, n=0, 2, 0	2 2.4%
TC 1, Week 112, n=0, 1, 0	1 1.2%
TC 1, Week 120, n=0, 1, 0	1 1.2%
TC 1, Week 128, n=0, 1, 0	1 1.2%
TC 1, Week 144, n=0, 1, 0	1 1.2%
TC 2, Week 8, n=0, 93, 0	78 92.9%
TC 2, Week 16, n=0, 80, 0	70 83.3%
TC 2, Week 24, n=0, 70, 0	58 69%
TC 2, Week 32, n=0, 31, 0	29 34.5%
TC 2, Week 40, n=0, 20, 0	16 19%
TC 2, Week 48, n=0, 11, 0	9 10.7%
TC 2, Week 56, n=0, 8, 0	7 8.3%
TC 2, Week 64, n=0, 6, 0	4 4.8%
TC 2, Week 72, n=0, 2, 0	2 2.4%
TC 2, Week 80, n=0, 2, 0	2 2.4%
TC 2, Week 96, n=0, 1, 0	1 1.2%
TC 3, Week 8, n=0, 60, 0	49 58.3%
TC 3, Week 16, n=0, 45, 0	36 42.9%
TC 3, Week 24, n=0, 29, 0	22 26.2%
TC 3, Week 32, n=0, 12, 0	10 11.9%
TC 3, Week 40, n=0, 4, 0	2 2.4%
TC 3, Week 48, n=0, 2, 0	1 1.2%
TC 3, Week 56, n=0, 1, 0	1 1.2%
TC 4, Week 8, n=0, 29, 0	24 28.6%
TC 4, Week 16, n=0, 24, 0	20 23.8%
TC 4, Week 24, n=0, 13, 0	11 13.1%
TC 4, Week 32, n=0, 4, 0	3 3.6%
TC 4, Week 40, n=0, 1, 0	1 1.2%
TC 4, Week 48, n=0, 1, 0	1 1.2%
TC 5, Week 8, n=0, 13, 0	10 11.9%
TC 5, Week 16, n=0, 8, 0	7 8.3%
TC 5, Week 24, n=0, 5, 0	4 4.8%
TC 5, Week 32, n=0, 5, 0	4 4.8%
TC 5, Week 40, n=0, 1, 0	1 1.2%
TC 6, Week 8, n=0, 6, 0	5 6%
TC 6, Week 16, n=0, 6, 0	5 6%
TC 6, Week 24, n=0, 5, 0	5 6%
TC 6, Week 32, n=0, 3, 0	3 3.6%

37. Secondary Outcome

Title	Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	136	0
TC 1, Week 8, n=0, 136, 0	118 140.5%
TC 1, Week 16, n=0, 100, 0	83 98.8%
TC 1, Week 24, n=0, 99, 0	80 95.2%
TC 1, Week 32, n=0, 50, 0	45 53.6%
TC 1, Week 40, n=0, 30, 0	27 32.1%
TC 1, Week 48, n=0, 23, 0	21 25%
TC 1, Week 56, n=0, 14, 0	13 15.5%
TC 1, Week 64, n=0, 7, 0	7 8.3%
TC 1, Week 72, n=0, 4, 0	4 4.8%
TC 1, Week 80, n=0, 1, 0	1 1.2%
TC 1, Week 88, n=0, 1, 0	1 1.2%
TC 1, Week 96, n=0, 1, 0	1 1.2%
TC 1, Week 104, n=0, 2, 0	2 2.4%
TC 1, Week 112, n=0, 1, 0	1 1.2%
TC 1, Week 120, n=0, 1, 0	1 1.2%
TC 1, Week 128, n=0, 1, 0	1 1.2%
TC 1, Week 144, n=0, 1, 0	1 1.2%
TC 2, Week 8, n=0, 93, 0	81 96.4%
TC 2, Week 16, n=0, 80, 0	67 79.8%
TC 2, Week 24, n=0, 70, 0	62 73.8%
TC 2, Week 32, n=0, 31, 0	29 34.5%
TC 2, Week 40, n=0, 20, 0	16 19%
TC 2, Week 48, n=0, 11, 0	9 10.7%
TC 2, Week 56, n=0, 8, 0	7 8.3%
TC 2, Week 64, n=0, 6, 0	4 4.8%
TC 2, Week 72, n=0, 2, 0	2 2.4%
TC 2, Week 80, n=0, 2, 0	2 2.4%
TC 2, Week 96, n=0, 1, 0	1 1.2%
TC 3, Week 8, n=0, 60, 0	49 58.3%
TC 3, Week 16, n=0, 45, 0	36 42.9%
TC 3, Week 24, n=0, 29, 0	23 27.4%
TC 3, Week 32, n=0, 12, 0	11 13.1%
TC 3, Week 40, n=0, 4, 0	3 3.6%
TC 3, Week 48, n=0, 2, 0	2 2.4%
TC 3, Week 56, n=0, 1, 0	1 1.2%
TC 4, Week 8, n=0, 29, 0	26 31%
TC 4, Week 16, n=0, 24, 0	20 23.8%
TC 4, Week 24, n=0, 13, 0	11 13.1%
TC 4, Week 32, n=0, 4, 0	3 3.6%
TC 4, Week 40, n=0, 1, 0	1 1.2%
TC 4, Week 48, n=0, 1	1 1.2%
TC 5, Week 8, n=0, 13, 0	12 14.3%
TC 5, Week 16, n=0, 8, 0	8 9.5%
TC 5, Week 24, n=0, 5, 0	5 6%
TC 5, Week 32, n=0, 5, 0	5 6%
TC 5, Week 40, n=0, 1, 0	1 1.2%
TC 6, Week 8, n=0, 6, 0	5 6%
TC 6, Week 16, n=0, 6, 0	6 7.1%
TC 6, Week 24, n=0, 5, 0	5 6%
TC 6, Week 32, n=0, 3, 0	3 3.6%

38. Secondary Outcome

Title	Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	136	0
TC 1, Week 8, n=0, 136, 0	121 144%
TC 1, Week 16, n=0, 100, 0	86 102.4%
TC 1, Week 24, n=0, 99, 0	87 103.6%
TC 1, Week 32, n=0, 50, 0	47 56%
TC 1, Week 40, n=0, 30, 0	27 32.1%
TC 1, Week 48, n=0, 23, 0	20 23.8%
TC 1, Week 56, n=0, 14, 0	13 15.5%
TC 1, Week 64, n=0, 7, 0	7 8.3%
TC 1, Week 72, n=0, 4, 0	4 4.8%
TC 1, Week 80, n=0, 1, 0	1 1.2%
TC 1, Week 88, n=0, 1, 0	1 1.2%
TC 1, Week 96, n=0, 1, 0	1 1.2%
TC 1, Week 104, n=0, 2, 0	2 2.4%
TC 1, Week 112, n=0, 1, 0	1 1.2%
TC 1, Week 120, n=0, 1, 0	1 1.2%
TC 1, Week 128, n=0, 1, 0	1 1.2%
TC 1, Week 144, n=0, 1, 0	1 1.2%
TC 2, Week 8, n=0, 93, 0	82 97.6%
TC 2, Week 16, n=0, 80, 0	74 88.1%
TC 2, Week 24, n=0, 70, 0	63 75%
TC 2, Week 32, n=0, 31, 0	29 34.5%
TC 2, Week 40, n=0, 20, 0	19 22.6%
TC 2, Week 48, n=0, 11, 0	11 13.1%
TC 2, Week 56, n=0, 8, 0	7 8.3%
TC 2, Week 64, n=0, 6, 0	5 6%
TC 2, Week 72, n=0, 2, 0	2 2.4%
TC 2, Week 80, n=0, 2, 0	2 2.4%
TC 2, Week 96, n=0, 1, 0	1 1.2%
TC 3, Week 8, n=0, 60, 0	54 64.3%
TC 3, Week 16, n=0, 45, 0	43 51.2%
TC 3, Week 24, n=0, 29, 0	24 28.6%
TC 3, Week 32, n=0, 12, 0	12 14.3%
TC 3, Week 40, n=0, 4, 0	3 3.6%
TC 3, Week 48, n=0, 2, 0	1 1.2%
TC 3, Week 56, n=0, 1, 0	1 1.2%
TC 4, Week 8, n=0, 29, 0	26 31%
TC 4, Week 16, n=0, 24, 0	23 27.4%
TC 4, Week 24, n=0, 13, 0	13 15.5%
TC 4, Week 32, n=0, 4, 0	4 4.8%
TC 4, Week 40, n=0, 1, 0	1 1.2%
TC 4, Week 48, n=0, 1, 0	1 1.2%
TC 5, Week 8, n=0, 13, 0	13 15.5%
TC 5, Week 16, n=0, 8, 0	8 9.5%
TC 5, Week 24, n=0, 5, 0	5 6%
TC 5, Week 32, n=0, 5, 0	5 6%
TC 5, Week 40, n=0, 1, 0	1 1.2%
TC 6, Week 8, n=0, 6, 0	5 6%
TC 6, Week 16, n=0, 6, 0	5 6%
TC 6, Week 24, n=0, 5, 0	5 6%
TC 6, Week 32, n=0, 3, 0	2 2.4%

39. Secondary Outcome

Title	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	144	0
Albumin, TC 1, BL, CC low, n=0, 144, 0	1 1.2%
Albumin, TC 1, PBL, CC low, n=0, 136, 0	1 1.2%
ALT, TC 1, BL, CC high, n=0, 144, 0	1 1.2%
ALT, TC 1, PBL, CC high, n=0, 136, 0	6 7.1%
ALP, TC 1, BL, CC high, n=0, 144, 0	0 0%
ALP, TC 1, PBL, CC high, n=0, 136, 0	4 4.8%
AST, TC 1, BL, CC high, n=0, 142, 0	0 0%
AST, TC 1, PBL, CC high, n=0, 136, 0	2 2.4%
TBIL, TC 1, BL, CC high, n=0, 144, 0	0 0%
TBIL, TC 1, PBL, CC high, n=0, 136, 0	0 0%
Calcium, TC 1, BL, CC low, n=0, 142, 0	0 0%
Calcium, TC 1, PBL, CC low, n=0, 136, 0	2 2.4%
Calcium, TC 1, BL, CC high, n=0, 142, 0	0 0%
Calcium, TC 1, PBL, CC high, n=0, 136, 0	0 0%
CO2/BCO, TC 1, BL, CC low, n=0, 142, 0	5 6%
CO2/BCO, TC 1, PBL, CC low, n=0, 136, 0	9 10.7%
CK, TC 1, BL, CC high, n=0, 144, 0	0 0%
CK, TC 1, PBL, CC high, n=0, 136, 0	1 1.2%
Creatinine, TC 1, BL, CC high, n=0, 144, 0	0 0%
Creatinine, TC 1,PBL, CC high, n=0, 136, 0	1 1.2%
GGT, TC 1, BL, CC high, n=0, 144, 0	7 8.3%
GGT, TC 1, PBL, CC high, n=0, 136, 0	8 9.5%
Potassium, TC 1, BL, CC high, n=0, 142, 0	2 2.4%
Potassium, TC 1, PBL, CC high, n=0, 136, 0	0 0%
Potassium, TC 1, BL, CC low, n=0, 142, 0	1 1.2%
Potassium, TC 1, PBL, CC low, n=0, 136, 0	1 1.2%
Urea/BUN, TC 1, BL, CC high, n=0, 144, 0	2 2.4%
Urea/BUN, TC 1, PBL, CC high, n=0, 136, 0	3 3.6%
Uric acid, TC 1, BL, CC high, n=0, 144, 0	0 0%
Uric acid, TC 1, PBL, CC high, n=0, 136, 0	0 0%
Albumin, TC 2, BL, CC low, n=0, 85, 0	0 0%
Albumin, TC 2, PBL, CC low, n=0, 92, 0	0 0%
ALT, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
ALT, TC 2, PBL, CC high, n=0, 92, 0	5 6%
ALP, TC 2, BL, CC high, n=0, 85, 0	0 0%
ALP, TC 2, PBL, CC high, n=0, 92, 0	1 1.2%
AST, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
AST, TC 2, PBL, CC high, n=0, 92, 0	2 2.4%
TBIL, TC 2, BL, CC high, n=0, 85, 0	0 0%
TBIL, TC 2, PBL, CC high, n=0, 92, 0	0 0%
Calcium, TC 2, BL, CC low, n=0, 85, 0	0 0%
Calcium, TC 2, PBL, CC low, n=0, 92, 0	0 0%
Calcium, TC 2, BL, CC high, n=0, 85, 0	0 0%
Calcium, TC 2, PBL, CC high, n=0, 92, 0	1 1.2%
CO2/BCO, TC 2, BL, CC low, n=0, 85, 0	1 1.2%
CO2/BCO, TC 2, PBL, CC low, n=0, 92	7 8.3%
CK, TC 2, BL, CC high, n=0, 85, 0	0 0%
CK, TC 2, PBL, CC high, n=0, 92, 0	0 0%
Creatinine, TC 2, BL, CC high, n=0, 85, 0	0 0%
Creatinine, TC 2,PBL, CC high, n=0, 92, 0	0 0%
GGT, TC 2, BL, CC high, n=0, 85, 0	3 3.6%
GGT, TC 2, PBL, CC high, n=0, 92, 0	3 3.6%
Potassium, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
Potassium, TC 2, PBL, CC high, n=0, 92, 0	0 0%
Potassium, TC 2, BL, CC low, n=0, 85, 0	0 0%
Potassium, TC 2, PBL, CC low, n=0, 92, 0	0 0%
Urea/BUN, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
Urea/BUN, TC 2, PBL, CC high, n=0, 92, 0	3 3.6%
Uric acid, TC 2, BL, CC high, n=0, 85, 0	0 0%
Uric acid, TC 2, PBL, CC high, n=0, 92, 0	1 1.2%
Albumin, TC 3, BL, CC low, n=0, 57, 0	0 0%
Albumin, TC 3, PBL, CC low, n=0, 62, 0	1 1.2%
ALT, TC 3, BL, CC high, n=0, 57, 0	1 1.2%
ALT, TC 3, PBL, CC high, n=0, 62, 0	1 1.2%
ALP, TC 3, BL, CC high, n=0, 57, 0	0 0%
ALP, TC 3, PBL, CC high, n=0, 62, 0	1 1.2%
AST, TC 3, BL, CC high, n=0, 57, 0	1 1.2%
AST, TC 3, PBL, CC high, n=0, 62, 0	0 0%
TBIL, TC 3, BL, CC high, n=0, 57, 0	0 0%
TBIL, TC 3, PBL, CC high, n=0, 62, 0	0 0%
Calcium, TC 3, BL, CC low, n=0, 57, 0	0 0%
Calcium, TC 3, PBL, CC low, n=0, 62, 0	0 0%
Calcium, TC 3, BL, CC high, n=0, 57, 0	1 1.2%
Calcium, TC 3, PBL, CC high, n=0, 62, 0	1 1.2%
CO2/BCO, TC 3, BL, CC low, n=0, 57, 0	0 0%
CO2/BCO, TC 3, PBL, CC low, n=0, 62, 0	2 2.4%
CK, TC 3, BL, CC high, n=0, 57, 0	0 0%
CK, TC 3, PBL, CC high, n=0, 62, 0	0 0%
Creatinine, TC 3, BL, CC high, n=0, 57, 0	0 0%
Creatinine, TC 3,PBL, CC high, n=0, 62, 0	0 0%
GGT, TC 3, BL, CC high, n=0, 57, 0	0 0%
GGT, TC 3, PBL, CC high, n=0, 62, 0	3 3.6%
Potassium, TC 3, BL, CC high, n=0, 57, 0	0 0%
Potassium, TC 3, PBL, CC high, n=0, 62, 0	0 0%
Potassium, TC 3, BL, CC low, n=0, 57, 0	0 0%
Potassium, TC 3, PBL, CC low, n=0, 62, 0	0 0%
Urea/BUN, TC 3, BL, CC high, n=0, 57, 0	0 0%
Urea/BUN, TC 3, PBL, CC high, n=0, 62, 0	0 0%
Uric acid, TC 3, BL, CC high, n=0, 57, 0	0 0%
Uric acid, TC 3, PBL, CC high, n=0, 62, 0	0 0%
Albumin, TC 4, BL, CC low, n=0, 28, 0	0 0%
Albumin, TC 4, PBL, CC low, n=0, 29, 0	0 0%
ALT, TC 4, BL, CC high, n=0, 28, 0	0 0%
ALT, TC 4, PBL, CC high, n=0, 29, 0	0 0%
ALP, TC 4, BL, CC high, n=0, 28, 0	1 1.2%
ALP, TC 4, PBL, CC high, n=0, 29, 0	1 1.2%
AST, TC 4, BL, CC high, n=0, 28, 0	0 0%
AST, TC 4, PBL, CC high, n=0, 29, 0	0 0%
TBIL, TC 4, BL, CC high, n=0, 28, 0	0 0%
TBIL, TC 4, PBL, CC high, n=0, 29, 0	1 1.2%
Calcium, TC 4, BL, CC low, n=0, 28, 0	0 0%
Calcium, TC 4, PBL, CC low, n=0, 29, 0	0 0%
Calcium, TC 4, BL, CC high, n=0, 28, 0	0 0%
Calcium, TC 4, PBL, CC high, n=0, 29, 0	0 0%
CO2/BCO, TC 4, BL, CC low, n=0, 28, 0	1 1.2%
CO2/BCO, TC 4, PBL, CC low, n=0, 29, 0	1 1.2%
CK, TC 4, BL, CC high, n=0, 28, 0	0 0%
CK, TC 4, PBL, CC high, n=0, 29, 0	0 0%
Creatinine, TC 4, BL, CC high, n=0, 28, 0	0 0%
Creatinine, TC 4,PBL, CC high, n=0, 29, 0	0 0%
GGT, TC 4, BL, CC high, n=0, 28, 0	2 2.4%
GGT, TC 4, PBL, CC high, n=0, 29, 0	1 1.2%
Potassium, TC 4, BL, CC high, n=0, 28, 0	0 0%
Potassium, TC 4, PBL, CC high, n=0, 29, 0	0 0%
Potassium, TC 4, BL, CC low, n=0, 28, 0	0 0%
Potassium, TC 4, PBL, CC low, n=0, 29, 0	0 0%
Urea/BUN, TC 4, BL, CC high, n=0, 28, 0	0 0%
Urea/BUN, TC 4, PBL, CC high, n=0, 29, 0	0 0%
Uric acid, TC 4, BL, CC high, n=0, 28, 0	0 0%
Uric acid, TC 4, PBL, CC high, n=0, 29, 0	0 0%
Albumin, TC 5, BL, CC low, n=0, 12, 0	0 0%
Albumin, TC 5, PBL, CC low, n=0, 13, 0	0 0%
ALT, TC 5, BL, CC high, n=0, 12	0 0%
ALT, TC 5, PBL, CC high, n=0, 13, 0	0 0%
ALP, TC 5, BL, CC high, n=0, 12, 0	0 0%
ALP, TC 5, PBL, CC high, n=0, 13, 0	0 0%
AST, TC 5, BL, CC high, n=0, 12, 0	0 0%
AST, TC 5, PBL, CC high, n=0, 13, 0	0 0%
TBIL, TC 5, BL, CC high, n=0, 12, 0	0 0%
TBIL, TC 5, PBL, CC high, n=0, 13, 0	1 1.2%
Calcium, TC 5, BL, CC low, n=0, 12, 0	0 0%
Calcium, TC 5, PBL, CC low, n=0, 13, 0	0 0%
Calcium, TC 5, BL, CC high, n=0, 12, 0	0 0%
Calcium, TC 5, PBL, CC high, n=0, 13, 0	0 0%
CO2/BCO, TC 5, BL, CC low, n=0, 12, 0	0 0%
CO2/BCO, TC 5, PBL, CC low, n=0, 13, 0	1 1.2%
CK, TC 5, BL, CC high, n=0, 12, 0	0 0%
CK, TC 5, PBL, CC high, n=0, 13, 0	0 0%
Creatinine, TC 5, BL, CC high, n=0, 12, 0	0 0%
Creatinine, TC 5,PBL, CC high, n=0, 13, 0	0 0%
GGT, TC 5, BL, CC high, n=0, 12, 0	1 1.2%
GGT, TC 5, PBL, CC high, n=0, 13, 0	1 1.2%
Potassium, TC 5, BL, CC high, n=0, 12, 0	0 0%
Potassium, TC 5, PBL, CC high, n=0, 13, 0	0 0%
Potassium, TC 5, BL, CC low, n=0, 12, 0	0 0%
Potassium, TC 5, PBL, CC low, n=0, 13, 0	0 0%
Urea/BUN, TC 5, BL, CC high, n=0, 12, 0	0 0%
Urea/BUN, TC 5, PBL, CC high, n=0, 13, 0	0 0%
Uric acid, TC 5, BL, CC high, n=0, 12, 0	0 0%
Uric acid, TC 5, PBL, CC high, n=0, 13, 0	0 0%
Albumin, TC 6, BL, CC low, n=0, 6, 0	0 0%
Albumin, TC 6, PBL, CC low, n=0, 6, 0	0 0%
ALT, TC 6, BL, CC high, n=0, 6, 0	0 0%
ALT, TC 6, PBL, CC high, n=0, 6, 0	0 0%
ALP, TC 6, BL, CC high, n=0, 6, 0	0 0%
ALP, TC 6, PBL, CC high, n=0, 6, 0	1 1.2%
AST, TC 6, BL, CC high, n=0, 6, 0	0 0%
AST, TC 6, PBL, CC high, n=0, 6, 0	0 0%
TBIL, TC 6, BL, CC high, n=0, 6, 0	1 1.2%
TBIL, TC 6, PBL, CC high, n=0, 6, 0	0 0%
Calcium, TC 6, BL, CC low, n=0, 6, 0	0 0%
Calcium, TC 6, PBL, CC low, n=0, 6, 0	0 0%
Calcium, TC 6, BL, CC high, n=0, 6, 0	0 0%
Calcium, TC 6, PBL, CC high, n=0, 6, 0	0 0%
CO2/BCO, TC 6, BL, CC low, n=0, 6, 0	0 0%
CO2/BCO, TC 6, PBL, CC low, n=0, 6, 0	0 0%
CK, TC 6, BL, CC high, n=0, 6, 0	0 0%
CK, TC 6, PBL, CC high, n=0, 6, 0	0 0%
Creatinine, TC , BL, CC high, n=0, 6, 0	0 0%
Creatinine, TC 6,PBL, CC high, n=0, 6, 0	0 0%
GGT, TC 6, BL, CC high, n=0, 6, 0	0 0%
GGT, TC 6, PBL, CC high, n=0, 6, 0	0 0%
Potassium, TC 6, BL, CC high, n=0, 6, 0	0 0%
Potassium, TC 6, PBL, CC high, n=0, 6, 0	0 0%
Potassium, TC 6, BL, CC low, n=0, 6, 0	0 0%
Potassium, TC 6, PBL, CC low, n=0, 6, 0	0 0%
Urea/BUN, TC 6, BL, CC high, n=0, 6, 0	0 0%
Urea/BUN, TC 6, PBL, CC high, n=0, 6, 0	0 0%
Uric acid, TC 6, BL, CC high, n=0, 6, 0	0 0%
Uric acid, TC 6, PBL, CC high, n=0, 6, 0	0 0%

40. Secondary Outcome

Title	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	143	0
Eosinophils, TC 1, BL,CC high, n=0, 143, 0	1 1.2%
Eosinophils, TC 1,PBL,CC high, n=0, 136, 0	1 1.2%
HCT, TC 1, BL, CC low, n=0, 143, 0	0 0%
HCT, TC 1, PBL, CC low, n=0, 136, 0	1 1.2%
Hb, TC 1, BL, CC low, n=0, 143, 0	1 1.2%
Hb, TC 1, PBL, CC low, n=0, 136, 0	5 6%
Monocytes, TC 1, BL, CC low, n=0, 143, 0	2 2.4%
Monocytes, TC 1, PBL, CC low, n=0, 136, 0	13 15.5%
Monocytes, TC 1, BL, CC high, n=0, 143, 0	0 0%
Monocytes, TC 1, PBL, CC high, n=0, 136, 0	0 0%
PC, TC 1, BL, CC low, n=0, 141, 0	0 0%
PC, TC 1, PBL, CC low, n=0, 136, 0	0 0%
PC, TC 1, BL, CC high, n=0, 141, 0	0 0%
PC, TC 1, PBL, CC high, n=0, 136, 0	1 1.2%
RBC count, TC 1, BL, CC low, n=0, 143, 0	1 1.2%
RBC count, TC 1, PBL, CC low, n=0, 136, 0	2 2.4%
TNUE, TC 1, BL, CC low, n=0, 142, 0	0 0%
TNUE, TC 1, PBL, CC low, n=0, 136, 0	0 0%
TNUE, TC 1, BL, CC high, n=0, 142, 0	0 0%
TNUE, TC 1,PBL, CC high, n=0, 136, 0	3 3.6%
WBC count, TC 1, BL, CC low, n=0, 143, 0	0 0%
WBC count, TC 1, PBL, CC low, n=0, 136, 0	0 0%
WBC count, TC 1, BL, CC high, n=0, 143, 0	0 0%
WBC count, TC 1, PBL, CC high, n=0, 136, 0	1 1.2%
Eosinophils, TC 2, BL,CC high, n=0, 85, 0	0 0%
Eosinophils, TC 2,PBL,CC high, n=0, 93, 0	0 0%
HCT, TC 2, BL, CC low, n=0, 85, 0	0 0%
HCT, TC 2, PBL, CC low, n=0, 93, 0	0 0%
Hb, TC 2, BL, CC low, n=0, 85, 0	1 1.2%
Hb, TC 2, PBL, CC low, n=0, 93, 0	1 1.2%
Monocytes, TC 2, BL, CC low, n=0, 85, 0	2 2.4%
Monocytes, TC 2, PBL, CC low, n=0, 93, 0	1 1.2%
Monocytes, TC 2, BL, CC high, n=0, 85, 0	0 0%
Monocytes, TC 2, PBL, CC high, n=0, 93, 0	1 1.2%
PC, TC 2, BL, CC low, n=0, 84, 0	0 0%
PC, TC 2, PBL, CC low, n=0, 93, 0	1 1.2%
PC, TC 2, BL, CC high, n=0, 84, 0	0 0%
PC, TC 2, PBL, CC high, n=0, 93, 0	0 0%
RBC count, TC 2, BL, CC low, n=0, 85, 0	1 1.2%
RBC count, TC 2, PBL, CC low, n=0, 93, 0	1 1.2%
TNUE, TC 2, BL, CC low, n=0, 85, 0	0 0%
TNUE, TC 2, PBL, CC low, n=0, 92, 0	1 1.2%
TNUE, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
TNUE, TC 2,PBL, CC high, n=0, 92, 0	0 0%
WBC count, TC 2, BL, CC low, n=0, 85, 0	0 0%
WBC count, TC 2, PBL, CC low, n=0, 93, 0	1 1.2%
WBC count, TC 2, BL, CC high, n=0, 85, 0	1 1.2%
WBC count, TC 2, PBL, CC high, n=0, 93, 0	0 0%
Eosinophils, TC 3, BL,CC high, n=0, 58, 0	0 0%
Eosinophils, TC 3,PBL,CC high, n=0, 62, 0	0 0%
HCT, TC 3, BL, CC low, n=0, 58, 0	0 0%
HCT, TC 3, PBL, CC low, n=0, 62, 0	0 0%
Hb, TC 3, BL, CC low, n=0, 58, 0	0 0%
Hb, TC 3, PBL, CC low, n=0, 62, 0	1 1.2%
Monocytes, TC 3, BL, CC low, n=0, 58, 0	1 1.2%
Monocytes, TC 3, PBL, CC low, n=0, 62, 0	3 3.6%
Monocytes, TC 3, BL, CC high, n=0, 58, 0	0 0%
Monocytes, TC 3, PBL, CC high, n=0, 62, 0	0 0%
PC, TC 3, BL, CC low, n=0, 57, 0	1 1.2%
PC, TC 3, PBL, CC low, n=0, 62, 0	1 1.2%
PC, TC 3, BL, CC high, n=0, 57, 0	0 0%
PC, TC 3, PBL, CC high, n=0, 62, 0	0 0%
RBC count, TC 3, BL, CC low, n=0, 58, 0	0 0%
RBC count, TC 3, PBL, CC low, n=0, 62, 0	0 0%
TNUE, TC 3, BL, CC low, n=0, 57, 0	0 0%
TNUE, TC 3, PBL, CC low, n=0, 60, 0	0 0%
TNUE, TC 3, BL, CC high, n=0, 57, 0	0 0%
TNUE, TC 3,PBL, CC high, n=0, 60, 0	0 0%
WBC count, TC 3, BL, CC low, n=0, 58, 0	0 0%
WBC count, TC 3, PBL, CC low, n=0, 62, 0	0 0%
WBC count, TC 3, BL, CC high, n=0, 58, 0	0 0%
WBC count, TC 4, PBL, CC high, n=0, 62, 0	0 0%
Eosinophils, TC 4, BL,CC high, n=0, 28, 0	0 0%
Eosinophils, TC 4,PBL,CC high, n=0, 29, 0	0 0%
HCT, TC 4, BL, CC low, n=0, 28, 0	0 0%
HCT, TC 4, PBL, CC low, n=0, 29, 0	0 0%
Hb, TC 4, BL, CC low, n=0, 28, 0	1 1.2%
Hb, TC 1, PBL, CC low, n=0, 29, 0	0 0%
Monocytes, TC 4, BL, CC low, n=0, 28, 0	1 1.2%
Monocytes, TC 4, PBL, CC low, n=0, 29, 0	0 0%
Monocytes, TC 4, BL, CC high, n=0, 28, 0	0 0%
Monocytes, TC 4, PBL, CC high, n=0, 29, 0	0 0%
PC, TC 4, BL, CC low, n=0, 28, 0	0 0%
PC, TC 4, PBL, CC low, n=0, 29, 0	0 0%
PC, TC 4, BL, CC high, n=0, 28, 0	0 0%
PC, TC 4, PBL, CC high, n=0, 29, 0	0 0%
RBC count, TC 4, BL, CC low, n=0, 28, 0	1 1.2%
RBC count, TC 4, PBL, CC low, n=0, 29, 0	0 0%
TNUE, TC 4, BL, CC low, n=0, 26, 0	0 0%
TNUE, TC 4, PBL, CC low, n=0, 28, 0	0 0%
TNUE, TC 4, BL, CC high, n=0, 26, 0	0 0%
TNUE, TC 4,PBL, CC high, n=0, 28, 0	0 0%
WBC count, TC 4, BL, CC low, n=0, 28, 0	0 0%
WBC count, TC 4, PBL, CC low, n=0, 29, 0	0 0%
WBC count, TC 4, BL, CC high, n=0, 28, 0	0 0%
WBC count, TC 4, PBL, CC high, n=0, 29, 0	0 0%
Eosinophils, TC 5, BL,CC high, n=0, 12, 0	0 0%
Eosinophils, TC 5,PBL,CC high, n=0, 13, 0	0 0%
HCT, TC 5, BL, CC low, n=0, 12, 0	0 0%
HCT, TC 5, PBL, CC low, n=0, 13, 0	0 0%
Hb, TC 5, BL, CC low, n=0, 12	0 0%
Hb, TC 5, PBL, CC low, n=0, 13, 0	0 0%
Monocytes, TC 5, BL, CC low, n=0, 12, 0	0 0%
Monocytes, TC 5, PBL, CC low, n=0, 13, 0	0 0%
Monocytes, TC 5, BL, CC high, n=0, 12, 0	0 0%
Monocytes, TC 5, PBL, CC high, n=0, 13, 0	0 0%
PC, TC 5, BL, CC low, n=0, 12, 0	0 0%
PC, TC 5, PBL, CC low, n=0, 13, 0	0 0%
PC, TC 5, BL, CC high, n=0, 12, 0	0 0%
PC, TC 5, PBL, CC high, n=0, 13, 0	0 0%
RBC count, TC 5, BL, CC low, n=0, 12, 0	0 0%
RBC count, TC 5, PBL, CC low, n=0, 13, 0	0 0%
TNUE, TC 5, BL, CC low, n=0, 11, 0	0 0%
TNUE, TC 5, PBL, CC low, n=0, 13	0 0%
TNUE, TC 5, BL, CC high, n=0, 11	0 0%
TNUE, TC 5,PBL, CC high, n=0, 13, 0	0 0%
WBC count, TC 5, BL, CC low, n=0, 12, 0	0 0%
WBC count, TC 5, PBL, CC low, n=0, 13, 0	0 0%
WBC count, TC 5, BL, CC high, n=0, 12, 0	0 0%
WBC count, TC 5, PBL, CC high, n=0, 13, 0	0 0%
Eosinophils, TC 6, BL,CC high, n=0, 6, 0	0 0%
Eosinophils, TC 6,PBL,CC high, n=0, 6, 0	0 0%
HCT, TC 6, BL, CC low, n=0, 6, 0	0 0%
HCT, TC 6, PBL, CC low, n=0, 6, 0	0 0%
Hb, TC 6, BL, CC low, n=0, 6, 0	0 0%
Hb, TC 6, PBL, CC low, n=0, 6, 0	0 0%
Monocytes, TC 6, BL, CC low, n=0, 6, 0	0 0%
Monocytes, TC 6, PBL, CC low, n=0, 6, 0	0 0%
Monocytes, TC 6, BL, CC high, n=0, 6, 0	0 0%
Monocytes, TC 6, PBL, CC high, n=0, 6, 0	0 0%
PC, TC 6, BL, CC low, n=0, 6, 0	0 0%
PC, TC 6, PBL, CC low, n=0, 6, 0	0 0%
PC, TC 6, BL, CC high, n=0, 6, 0	0 0%
PC, TC 6, PBL, CC high, n=0, 6, 0	0 0%
RBC count, TC 6, BL, CC low, n=0, 6, 0	0 0%
RBC count, TC 6, PBL, CC low, n=0, 6, 0	0 0%
TNUE, TC 6, BL, CC low, n=0, 6, 0	0 0%
TNUE, TC 6, PBL, CC low, n=0, 6, 0	0 0%
TNUE, TC 6, BL, CC high, n=0, 6, 0	0 0%
TNUE, TC 6,PBL, CC high, n=0, 6, 0	0 0%
WBC count, TC 6, BL, CC low, n=0, 6, 0	0 0%
WBC count, TC 6, PBL, CC low, n=0, 6, 0	0 0%
WBC count, TC 6, BL, CC high, n=0, 6, 0	0 0%
WBC count, TC 6, PBL, CC high, n=0, 6, 0	0 0%

41. Secondary Outcome

Title	Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	148	0
DBP, TC 1, BL, <LLN, n=0, 148, 0	0 0%
DBP, TC 1, PBL, <LLN, n=0, 148, 0	2 2.4%
DBP, TC 1, BL, >ULN, n=0, 148, 0	0 0%
DBP, TC 1, PBL, >ULN, n=0, 148, 0	1 1.2%
SBP, TC 1, BL, <LLN, n=0, 148, 0	0 0%
SBP, TC 1, PBL, <LLN, n=0, 148, 0	7 8.3%
SBP, TC 1, BL, >ULN, n=0, 148, 0	0 0%
SBP, TC 1, PBL, >ULN, n=0, 148, 0	7 8.3%
HR, TC 1, BL, <LLN, n=0, 148, 0	0 0%
HR, TC 1, PBL, <LLN, n=0, 148, 0	0 0%
HR, TC 1, BL, >ULN, n=0, 148, 0	0 0%
HR, TC 1, PBL, >ULN, n=0, 148, 0	1 1.2%
DBP, TC 2, BL, <LLN, n=0, 93, 0	0 0%
DBP, TC 2, PBL, <LLN, n=0, 93, 0	0 0%
DBP, TC 2, BL, >ULN, n=0, 93, 0	0 0%
DBP, TC 2, PBL, >ULN, n=0, 93, 0	0 0%
SBP, TC 2, BL, <LLN, n=0, 93, 0	0 0%
SBP, TC 2, PBL, <LLN, n=0, 93, 0	3 3.6%
SBP, TC 2, BL, >ULN, n=0, 93, 0	0 0%
SBP, TC 2, PBL, >ULN, n=0, 93, 0	6 7.1%
HR, TC 2, BL, <LLN, n=0, 93, 0	0 0%
HR, TC 2, PBL, <LLN, n=0, 93, 0	0 0%
HR, TC 2, BL, >ULN, n=0, 93, 0	0 0%
HR, TC 2, PBL, >ULN, n=0, 93, 0	1 1.2%
DBP, TC 3, BL, <LLN, n=0, 62, 0	0 0%
DBP, TC 3, PBL, <LLN, n=0, 63, 0	0 0%
DBP, TC 3, BL, >ULN, n=0, 62, 0	0 0%
DBP, TC 3, PBL, >ULN, n=0, 63, 0	0 0%
SBP, TC 3, BL, <LLN, n=0, 62, 0	0 0%
SBP, TC 3, PBL, <LLN, n=0, 63, 0	0 0%
SBP, TC 3, BL, >ULN, n=0, 62, 0	0 0%
SBP, TC 3, PBL, >ULN, n=0, 63, 0	0 0%
HR, TC 3, BL, <LLN, n=0, 62, 0	0 0%
HR, TC 3, PBL, <LLN, n=0, 63, 0	0 0%
HR, TC 3, BL, >ULN, n=0, 62, 0	0 0%
HR, TC 3, PBL, >ULN, n=0, 63, 0	0 0%
DBP, TC 4, BL, <LLN, n=0, 29, 0	0 0%
DBP, TC 4, PBL, <LLN, n=0, 30, 0	0 0%
DBP, TC 4, BL, >ULN, n=0, 29, 0	0 0%
DBP, TC 4, PBL, >ULN, n=0, 30, 0	0 0%
SBP, TC 4, BL, <LLN, n=0, 29, 0	0 0%
SBP, TC 4, PBL, <LLN, n=0, 30, 0	2 2.4%
SBP, TC 4, BL, >ULN, n=0, 29, 0	0 0%
SBP, TC 4, PBL, >ULN, n=0, 30, 0	1 1.2%
HR, TC 4, BL, <LLN, n=0, 29, 0	0 0%
HR, TC 4, PBL, <LLN, n=0, 30, 0	0 0%
HR, TC 4, BL, >ULN, n=0, 29, 0	0 0%
HR, TC 4, PBL, >ULN, n=0, 30, 0	0 0%
DBP, TC 5, BL, <LLN, n=0, 13, 0	0 0%
DBP, TC 5, PBL, <LLN, n=0, 13, 0	0 0%
DBP, TC 5, BL, >ULN, n=0, 13, 0	0 0%
DBP, TC 5, PBL, >ULN, n=0, 13, 0	0 0%
SBP, TC 5, BL, <LLN, n=0, 13, 0	0 0%
SBP, TC 5, PBL, <LLN, n=0, 13, 0	2 2.4%
SBP, TC 5, BL, >ULN, n=0, 13, 0	0 0%
SBP, TC 5, PBL, >ULN, n=0, 13, 0	0 0%
HR, TC 5, BL, <LLN, n=0, 13, 0	0 0%
HR, TC 5, PBL, <LLN, n=0, 13, 0	0 0%
HR, TC 5, BL, >ULN, n=0, 13, 0	0 0%
HR, TC 5, PBL, >ULN, n=0, 13, 0	0 0%
DBP, TC 6, BL, <LLN, n=0, 6, 0	0 0%
DBP, TC 6, PBL, <LLN, n=0, 6, 0	0 0%
DBP, TC 6, BL, >ULN, n=0, 6, 0	0 0%
DBP, TC 6, PBL, >ULN, n=0, 6, 0	0 0%
SBP, TC 6, BL, <LLN, n=0, 6, 0	0 0%
SBP, TC 6, PBL, <LLN, n=0, 6, 0	1 1.2%
SBP, TC 6, BL, >ULN, n=0, 6, 0	0 0%
SBP, TC 6, PBL, >ULN, n=0, 6, 0	0 0%
HR, TC 6, BL, <LLN, n=0, 6, 0	0 0%
HR, TC 6, PBL, <LLN, n=0, 6, 0	0 0%
HR, TC 6, BL, >ULN, n=0, 6, 0	0 0%
HR, TC 6, PBL, >ULN, n=0, 6, 0	0 0%

42. Secondary Outcome

Title	Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Description	The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.
Time Frame	From baseline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	141	0
IgA, TC 1, BL, <LLN, n=0, 141, 0	1 1.2%
IgA, TC 1, PBL, <LLN, n=0, 133, 0	1 1.2%
IgA, TC 1, BL, >ULN, n=0, 141, 0	16 19%
IgA, TC 1, PBL, >ULN, n=0, 133, 0	14 16.7%
IgG, TC 1, BL, <LLN, n=0, 141, 0	0 0%
IgG, TC 1, PBL, <LLN, n=0, 133, 0	4 4.8%
IgG, TC 1, BL, >ULN, n=0, 141, 0	43 51.2%
IgG, TC 1, PBL, >ULN, n=0, 133, 0	25 29.8%
IgM, TC 1, BL, <LLN, n=0, 141, 0	7 8.3%
IgM, TC 1, PBL, <LLN, n=0, 133, 0	18 21.4%
IgM, TC 1, BL, >ULN, n=0, 141, 0	19 22.6%
IgM, TC 1, PBL, >ULN, n=0, 133, 0	12 14.3%
IgA, TC 2, BL, <LLN, n=0, 85, 0	0 0%
IgA, TC 2, PBL, <LLN, n=0, 93, 0	0 0%
IgA, TC 2, BL, >ULN, n=0, 85, 0	9 10.7%
IgA, TC 2, PBL, >ULN, n=0, 93, 0	1 1.2%
IgG, TC 2, BL, <LLN, n=0, 85, 0	1 1.2%
IgG, TC 2, PBL, <LLN, n=0, 93, 0	3 3.6%
IgG, TC 2, BL, >ULN, n=0, 85, 0	11 13.1%
IgG, TC 2, PBL, >ULN, n=0, 93, 0	12 14.3%
IgM, TC 2, BL, <LLN, n=0, 85, 0	10 11.9%
IgM, TC 2, PBL, <LLN, n=0, 93, 0	18 21.4%
IgM, TC 2, BL, >ULN, n=0, 85, 0	6 7.1%
IgM, TC 2, PBL, >ULN, n=0, 93, 0	5 6%
IgA, TC 3, BL, <LLN, n=0, 59, 0	0 0%
IgA, TC 3, PBL, <LLN, n=0, 62, 0	0 0%
IgA, TC 3, BL, >ULN, n=0, 59, 0	5 6%
IgA, TC 3, PBL, >ULN, n=0, 62, 0	5 6%
IgG, TC 3, BL, <LLN, n=0, 59, 0	0 0%
IgG, TC 3, PBL, <LLN, n=0, 62, 0	2 2.4%
IgG, TC 3, BL, >ULN, n=0, 59, 0	6 7.1%
IgG, TC 3, PBL, >ULN, n=0, 62, 0	5 6%
IgM, TC 3, BL, <LLN, n=0, 59, 0	7 8.3%
IgM, TC 3, PBL, <LLN, n=0, 62, 0	11 13.1%
IgM, TC 3, BL, >ULN, n=0, 59, 0	3 3.6%
IgM, TC 3, PBL, >ULN, n=0, 62, 0	2 2.4%
IgA, TC 4, BL, <LLN, n=0, 28, 0	0 0%
IgA, TC 4, PBL, <LLN, n=0, 29, 0	0 0%
IgA, TC 4, BL, >ULN, n=0, 28, 0	4 4.8%
IgA, TC 4, PBL, >ULN, n=0, 29, 0	5 6%
IgG, TC 4, BL, <LLN, n=0, 28, 0	0 0%
IgG, TC 4, PBL, <LLN, n=0, 29, 0	1 1.2%
IgG, TC 4, BL, >ULN, n=0, 28, 0	1 1.2%
IgG, TC 4, PBL, >ULN, n=0, 29, 0	1 1.2%
IgM, TC 4, BL, <LLN, n=0, 28, 0	1 1.2%
IgM, TC 4, PBL, <LLN, n=0, 29, 0	2 2.4%
IgM, TC 4, BL, >ULN, n=0, 28, 0	1 1.2%
IgM, TC 4, PBL, >ULN, n=0, 29, 0	1 1.2%
IgA, TC 5, BL, <LLN, n=0, 12, 0	0 0%
IgA, TC 5, PBL, <LLN, n=0, 13, 0	0 0%
IgA, TC 5, BL, >ULN, n=0, 12, 0	2 2.4%
IgA, TC 5, PBL, >ULN, n=0, 13, 0	2 2.4%
IgG, TC 5, BL, <LLN, n=0, 12, 0	1 1.2%
IgG, TC 5, PBL, <LLN, n=0, 13, 0	1 1.2%
IgG, TC 5, BL, >ULN, n=0, 12, 0	0 0%
IgG, TC 5, PBL, >ULN, n=0, 13, 0	1 1.2%
IgM, TC 5, BL, <LLN, n=0, 12, 0	0 0%
IgM, TC 5, PBL, <LLN, n=0, 13, 0	0 0%
IgM, TC 5, BL, >ULN, n=0, 12, 0	1 1.2%
IgM, TC 5, PBL, >ULN, n=0, 13, 0	1 1.2%
IgA, TC 6, BL, <LLN, n=0, 6, 0	0 0%
IgA, TC 6, PBL, <LLN, n=0, 6, 0	0 0%
IgA, TC 6, BL, >ULN, n=0, 6, 0	0 0%
IgA, TC 6, PBL, >ULN, n=0, 6, 0	0 0%
IgG, TC 6, BL, <LLN, n=0, 6, 0	0 0%
IgG, TC 6, PBL, <LLN, n=0, 6, 0	0 0%
IgG, TC 6, BL, >ULN, n=0, 6, 0	0 0%
IgG, TC 6, PBL, >ULN, n=0, 6, 0	0 0%
IgM, TC 6, BL, <LLN, n=0, 6, 0	0 0%
IgM, TC 6, PBL, <LLN, n=0, 6, 0	0 0%
IgM, TC 6, BL, >ULN, n=0, 6, 0	0 0%
IgM, TC 6, PBL, >ULN, n=0, 6, 0	0 0%

43. Secondary Outcome

Title	Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods
Description	Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.
Time Frame	From basline up to Week 144

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	118	0
TC 1, BL, n=0, 76, 0	1 1.2%
TC 1, PBL, n=0, 118, 0	1 1.2%
TC 2, BL, n=0, 45, 0	0 0%
TC 2, PBL, n=0, 81, 0	1 1.2%
TC 3, BL, n=0, 30, 0	1 1.2%
TC 3, PBL, n=0, 48, 0	0 0%
TC 4, BL, n=0, 10, 0	0 0%
TC 4, PBL, n=0, 25, 0	0 0%
TC 5, BL, n=0, 4, 0	0 0%
TC 5, PBL, n=0, 8, 0	0 0%
TC 6, BL, n=0, 3, 0	0 0%
TC 6, PBL, n=0, 6, 0	0 0%

44. Secondary Outcome

Title	Number of Participants With Any Serious Adverse Event During the Follow-up Period
Description	A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.
Time Frame	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	132
Number [Participants]	17 20.2%

45. Secondary Outcome

Title	Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period
Description	The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.
Time Frame	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	123
IgA <LLN	0 0%
IgA >ULN	15 17.9%
IgG <LLN	7 8.3%
IgG >ULN	18 21.4%
IgM <LLN	23 27.4%
IgM >ULN	4 4.8%

46. Secondary Outcome

Title	Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab
Description	Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.
Time Frame	From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	63
Relative to first dose, n=0, 0, 63	22.013
Relative to last dose, n=0, 0, 60	12.567

47. Secondary Outcome

Title	Number of Participants With a Positive JC Virus Test Result During the Follow-up Period
Description	Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.
Time Frame	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	132
Number [Participants]	7 8.3%

48. Secondary Outcome

Title	Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period
Description	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.
Time Frame	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	132
ALT	1 1.2%
ALP	1 1.2%
CK	2 2.4%
CO2/BCO	2 2.4%
GGT	1 1.2%
TBIL	1 1.2%
Urea/BUN	1 1.2%

49. Secondary Outcome

Title	Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period
Description	Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.
Time Frame	From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period
Arm/Group Description
Measure Participants	0	0	132
Eosinophils	1 1.2%
Total neutrophils	2 2.4%
Platelet count	1 1.2%

Adverse Events

Time Frame	Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period.
Adverse Event Reporting Description	SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Arm/Group Title	Placebo: DB Period		Ofatumumab 700 mg: DB and OL Periods		Placebo or Ofatumumab 700 mg: Follow-up Period
Arm/Group Description	Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.		SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).		SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
All Cause Mortality
	Placebo: DB Period		Ofatumumab 700 mg: DB and OL Periods		Placebo or Ofatumumab 700 mg: Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo: DB Period		Ofatumumab 700 mg: DB and OL Periods		Placebo or Ofatumumab 700 mg: Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/83 (7.2%)		30/148 (20.3%)		17/132 (12.9%)
Blood and lymphatic system disorders
Pancytopenia	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Cardiac disorders
Myocardial infarction	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Eye disorders
Retinal detachment	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Cataract	0/83 (0%)		2/148 (1.4%)		0/132 (0%)
Gastrointestinal disorders
Gastritis	0/83 (0%)		0/148 (0%)		0/132 (0%)
General disorders
Implant site reaction	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Hepatobiliary disorders
Bile duct stone	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Immune system disorders
Anaphylactic reaction	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Hypersensitivity	0/83 (0%)		2/148 (1.4%)		0/132 (0%)
Anaphylactic shock	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Infections and infestations
Meningitis viral	1/83 (1.2%)		0/148 (0%)		0/132 (0%)
Urinary tract infection	0/83 (0%)		2/148 (1.4%)		0/132 (0%)
Cellulitis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Gastroenteritis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Herpes oesophagitis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Oesophageal candidiasis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Oral candidiasis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Respiratory tract infection	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Urosepsis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Pneumonia	0/83 (0%)		0/148 (0%)		2/132 (1.5%)
Haemophilus infection	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Pyelonephritis	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Septic shock	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Injury, poisoning and procedural complications
Post procedural complication	1/83 (1.2%)		0/148 (0%)		0/132 (0%)
Spinal compression fracture	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Hip fracture	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Intervertebral disc protrusion	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Ulna fracture	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Infusion related reaction	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Investigations
Alanine aminotransferase increased	0/83 (0%)		2/148 (1.4%)		0/132 (0%)
John Cunningham (JC) virus test positive	1/83 (1.2%)		0/148 (0%)		2/132 (1.5%)
Transaminases increased	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/83 (1.2%)		0/148 (0%)		0/132 (0%)
Musculoskeletal and connective tissue disorders
Foot deformity	0/83 (0%)		1/148 (0.7%)		1/132 (0.8%)
Arthralgia	1/83 (1.2%)		0/148 (0%)		1/132 (0.8%)
Rheumatoid arthritis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Arthritis	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Osteoarthritis	0/83 (0%)		0/148 (0%)		0/132 (0%)
Musculoskeletal pain	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Osteoporotic fracture	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Nervous system disorders
Cervical myelopathy	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Cerebrovascular accident	1/83 (1.2%)		0/148 (0%)		0/132 (0%)
Renal and urinary disorders
Nephrolithiasis	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Reproductive system and breast disorders
Ovarian cyst ruptured	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Vaginal prolapse	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Respiratory, thoracic and mediastinal disorders
Pleurisy	1/83 (1.2%)		0/148 (0%)		0/132 (0%)
Skin and subcutaneous tissue disorders
Rash	0/83 (0%)		1/148 (0.7%)		0/132 (0%)
Vascular disorders
Deep vein thrombosis	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Peripheral ischaemia	0/83 (0%)		0/148 (0%)		1/132 (0.8%)
Other (Not Including Serious) Adverse Events
	Placebo: DB Period		Ofatumumab 700 mg: DB and OL Periods		Placebo or Ofatumumab 700 mg: Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/83 (43.4%)		133/148 (89.9%)		0/132 (0%)
Blood and lymphatic system disorders
Anaemia	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Eye disorders
Dry eye	2/83 (2.4%)		0/148 (0%)		0/132 (0%)
Cataract	0/83 (0%)		5/148 (3.4%)		0/132 (0%)
Gastrointestinal disorders
Abdominal pain	2/83 (2.4%)		3/148 (2%)		0/132 (0%)
Nausea	2/83 (2.4%)		5/148 (3.4%)		0/132 (0%)
Abdominal pain upper	1/83 (1.2%)		5/148 (3.4%)		0/132 (0%)
Constipation	3/83 (3.6%)		0/148 (0%)		0/132 (0%)
Diarrhoea	0/83 (0%)		6/148 (4.1%)		0/132 (0%)
Sensation of foreign body	0/83 (0%)		3/148 (2%)		0/132 (0%)
Vomiting	0/83 (0%)		3/148 (2%)		0/132 (0%)
General disorders
Pyrexia	2/83 (2.4%)		4/148 (2.7%)		0/132 (0%)
Chest discomfort	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Chest pain	0/83 (0%)		3/148 (2%)		0/132 (0%)
Immune system disorders
Anaphylactic reaction	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Hypersensitivity	0/83 (0%)		3/148 (2%)		0/132 (0%)
Infections and infestations
Gastroenteritis	4/83 (4.8%)		9/148 (6.1%)		0/132 (0%)
Nasopharyngitis	5/83 (6%)		7/148 (4.7%)		0/132 (0%)
Urinary tract infection	4/83 (4.8%)		9/148 (6.1%)		0/132 (0%)
Bronchitis	1/83 (1.2%)		7/148 (4.7%)		0/132 (0%)
Rhinitis	2/83 (2.4%)		4/148 (2.7%)		0/132 (0%)
Upper respiratory tract infection	2/83 (2.4%)		6/148 (4.1%)		0/132 (0%)
Cervicitis	2/83 (2.4%)		0/148 (0%)		0/132 (0%)
Herpes zoster	2/83 (2.4%)		5/148 (3.4%)		0/132 (0%)
Onychomycosis	0/83 (0%)		3/148 (2%)		0/132 (0%)
Pharyngitis	2/83 (2.4%)		3/148 (2%)		0/132 (0%)
Erysipelas	0/83 (0%)		3/148 (2%)		0/132 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/83 (0%)		8/148 (5.4%)		0/132 (0%)
Investigations
Blood pressure increased	2/83 (2.4%)		0/148 (0%)		0/132 (0%)
Alanine aminotransferase increased	0/83 (0%)		5/148 (3.4%)		0/132 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/83 (4.8%)		0/148 (0%)		0/132 (0%)
Back pain	0/83 (0%)		10/148 (6.8%)		0/132 (0%)
Arthritis	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Spinal osteoarthritis	0/83 (0%)		4/148 (2.7%)		0/132 (0%)
Nervous system disorders
Dizziness	0/83 (0%)		8/148 (5.4%)		0/132 (0%)
Headache	3/83 (3.6%)		4/148 (2.7%)		0/132 (0%)
Post herpetic neuralgia	0/83 (0%)		3/148 (2%)		0/132 (0%)
Sciatica	0/83 (0%)		3/148 (2%)		0/132 (0%)
Psychiatric disorders
Depression	0/83 (0%)		6/148 (4.1%)		0/132 (0%)
Anxiety	0/83 (0%)		5/148 (3.4%)		0/132 (0%)
Insomnia	0/83 (0%)		3/148 (2%)		0/132 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/83 (1.2%)		19/148 (12.8%)		0/132 (0%)
Throat irritation	0/83 (0%)		20/148 (13.5%)		0/132 (0%)
Dyspnoea	0/83 (0%)		13/148 (8.8%)		0/132 (0%)
Oropharyngeal pain	2/83 (2.4%)		3/148 (2%)		0/132 (0%)
Dysphonia	0/83 (0%)		3/148 (2%)		0/132 (0%)
Oropharyngeal discomfort	0/83 (0%)		3/148 (2%)		0/132 (0%)
Throat tightness	0/83 (0%)		6/148 (4.1%)		0/132 (0%)
Skin and subcutaneous tissue disorders
Rash	2/83 (2.4%)		53/148 (35.8%)		0/132 (0%)
Pruritus	2/83 (2.4%)		16/148 (10.8%)		0/132 (0%)
Urticaria	0/83 (0%)		24/148 (16.2%)		0/132 (0%)
Erythema	1/83 (1.2%)		9/148 (6.1%)		0/132 (0%)
Rash pruritic	0/83 (0%)		3/148 (2%)		0/132 (0%)
Vascular disorders
Flushing	0/83 (0%)		6/148 (4.1%)		0/132 (0%)
Hypertension	0/83 (0%)		8/148 (5.4%)		0/132 (0%)
Hypotension	2/83 (2.4%)		0/148 (0%)		0/132 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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