Trial Outcomes & Findings for Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy (NCT NCT00611455)

Last Updated: 2017-11-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

265 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2017-11-06

Participant Flow

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 Participants who completed the OL Period, or who were withdrawn, entered a Follow-up (FU) period (approximately 2 years).

Participant milestones

Participant milestones
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) 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).	Placebo or OFA 700 mg: FU 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who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a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.
DB Treatment Period (24 Weeks) STARTED	134	131	0
DB Treatment Period (24 Weeks) COMPLETED	121	117	0
DB Treatment Period (24 Weeks) NOT COMPLETED	13	14	0
OL Treatment Period (120 Weeks) STARTED	0	231	0
OL Treatment Period (120 Weeks) COMPLETED	0	52	0
OL Treatment Period (120 Weeks) NOT COMPLETED	0	179	0
Follow-up Period (Approximately 2 Years) STARTED	0	0	260
Follow-up Period (Approximately 2 Years) COMPLETED	0	0	49
Follow-up Period (Approximately 2 Years) NOT COMPLETED	0	0	211

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) 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).	Placebo or OFA 700 mg: FU 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.
DB Treatment Period (24 Weeks) Adverse Event	2	8	0
DB Treatment Period (24 Weeks) Lack of Efficacy	2	0	0
DB Treatment Period (24 Weeks) Protocol Violation	4	1	0
DB Treatment Period (24 Weeks) Withdrawal by Subject	2	3	0
DB Treatment Period (24 Weeks) Randomized in Error; Not Treated	2	2	0
DB Treatment Period (24 Weeks) Randomized, but Not Treated	1	0	0
OL Treatment Period (120 Weeks) Adverse Event	0	17	0
OL Treatment Period (120 Weeks) Lack of Efficacy	0	9	0
OL Treatment Period (120 Weeks) Protocol Violation	0	3	0
OL Treatment Period (120 Weeks) Protocol-defined Stopping Criteria Met	0	12	0
OL Treatment Period (120 Weeks) Study Closed/Terminated	0	110	0
OL Treatment Period (120 Weeks) Lost to Follow-up	0	5	0
OL Treatment Period (120 Weeks) Physician Decision	0	5	0
OL Treatment Period (120 Weeks) Withdrawal by Subject	0	18	0
Follow-up Period (Approximately 2 Years) Adverse Event	0	0	30
Follow-up Period (Approximately 2 Years) Lack of Efficacy	0	0	12
Follow-up Period (Approximately 2 Years) Protocol Violation	0	0	4
Follow-up Period (Approximately 2 Years) Protocol-defined Stopping Criteria Met	0	0	23
Follow-up Period (Approximately 2 Years) Study Closed/Terminated	0	0	80
Follow-up Period (Approximately 2 Years) Lost to Follow-up	0	0	13
Follow-up Period (Approximately 2 Years) Withdrawal by Subject	0	0	49

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=131 Participants 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 n=129 Participants 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 n=260 Participants Total of all reporting groups
Age, Continuous	53.6 Years STANDARD_DEVIATION 11.50 • n=93 Participants	51.7 Years STANDARD_DEVIATION 11.24 • n=4 Participants	52.7 Years STANDARD_DEVIATION 11.39 • n=27 Participants
Sex: Female, Male Female	108 Participants n=93 Participants	106 Participants n=4 Participants	214 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino	52 participants n=93 Participants	51 participants n=4 Participants	103 participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	79 participants n=93 Participants	78 participants n=4 Participants	157 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

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

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants 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 n=129 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24	35 participants	64 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants 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 n=129 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 4	42 participants	52 participants	—
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 8	43 participants	66 participants	—
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 12	44 participants	71 participants	—
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 16	38 participants	67 participants	—
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 20	40 participants	62 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants 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 n=129 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 4	13 participants	14 participants	—
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 8	12 participants	23 participants	—
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 12	14 participants	36 participants	—
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 16	13 participants	37 participants	—
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 20	19 participants	31 participants	—
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 24	14 participants	35 participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants 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 n=129 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 4	6 participants	4 participants	—
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 8	3 participants	10 participants	—
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 12	6 participants	19 participants	—
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 16	5 participants	18 participants	—
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 20	6 participants	18 participants	—
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 24	3 participants	17 participants	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 4, n=129, 124	6.0 percent change Interval -77.0 to 85.0	13.0 percent change Interval -98.0 to 92.0	—
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 8, n=130, 126	5.5 percent change Interval -250.0 to 86.0	22.0 percent change Interval -264.0 to 84.0	—
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 12, n=130, 126	0.5 percent change Interval -200.0 to 85.0	25.0 percent change Interval -73.0 to 100.0	—
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 16, n=130, 126	0.0 percent change Interval -210.0 to 85.0	26.0 percent change Interval -138.0 to 93.0	—
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 20, n=130, 126	4.0 percent change Interval -185.0 to 90.0	21.0 percent change Interval -74.0 to 92.0	—
Median ACRn at Weeks 4, 8, 12, 16, 20, and 24 Week 24, n=130, 126	-2.5 percent change Interval -272.0 to 90.0	21.0 percent change Interval -87.0 to 95.0	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 4, n=129, 124	4.78 scores on a scale Standard Deviation 1.241	4.74 scores on a scale Standard Deviation 1.099	—
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 8, n=130, 126	4.75 scores on a scale Standard Deviation 1.205	4.41 scores on a scale Standard Deviation 1.285	—
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 12, n=130, 126	4.66 scores on a scale Standard Deviation 1.333	4.14 scores on a scale Standard Deviation 1.367	—
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 16, n=130, 126	4.78 scores on a scale Standard Deviation 1.327	4.11 scores on a scale Standard Deviation 1.296	—
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 20, n=130, 126	4.78 scores on a scale Standard Deviation 1.387	4.13 scores on a scale Standard Deviation 1.395	—
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 24, n=130, 126	4.98 scores on a scale Standard Deviation 1.437	4.12 scores on a scale Standard Deviation 1.270	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

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

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 4, n=129, 124	5.48 scores on a scale Standard Deviation 1.332	5.51 scores on a scale Standard Deviation 1.127	—
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 8, n=130, 126	5.43 scores on a scale Standard Deviation 1.289	5.14 scores on a scale Standard Deviation 1.276	—
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 12, n=130, 126	5.31 scores on a scale Standard Deviation 1.349	4.83 scores on a scale Standard Deviation 1.358	—
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 16, n=130, 126	5.43 scores on a scale Standard Deviation 1.329	4.81 scores on a scale Standard Deviation 1.310	—
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 20, n=130, 126	5.41 scores on a scale Standard Deviation 1.414	4.77 scores on a scale Standard Deviation 1.427	—
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant Week 24, n=130, 126	5.67 scores on a scale Standard Deviation 1.439	4.84 scores on a scale Standard Deviation 1.360	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

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

Outcome measures

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

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

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

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.

Outcome measures

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

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

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

Outcome measures

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

SECONDARY outcome

Timeframe: Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants 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 n=112 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)	59 participants	74 participants	—

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population

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

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants 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 n=129 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With Clinical Remission at Week 24	7 participants	13 participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in Tender Joint Count at Week 24	-5 number of tender joints Interval -38.0 to 36.0	-12 number of tender joints Interval -52.0 to 20.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in Swollen Joint Count at Week 24	-4.50 number of swollen joints Interval -24.0 to 16.0	-8.00 number of swollen joints Interval -43.0 to 12.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=128 Participants 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 n=119 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in the Participant-assessed Pain Score at Week 24	-5 scores on a scale Interval -93.0 to 54.0	-22 scores on a scale Interval -95.0 to 35.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in Participant-assessed Global Disease Score at Week 24	-6.0 scores on a scale Interval -76.0 to 57.0	-16.5 scores on a scale Interval -83.0 to 28.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=124 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in the Physician-assessed Global Disease Score at Week 24	-9.50 scores on a scale Interval -70.0 to 37.0	-20.50 scores on a scale Interval -77.0 to 17.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=123 Participants 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 n=122 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in HAQ-DI Score at Week 24	-0.25 scores on a scale Interval -2.4 to 1.3	-0.38 scores on a scale Interval -2.4 to 1.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in CRP at Week 24	-0.10 milligrams per liter (mg/L) Interval -55.1 to 96.2	-4.85 milligrams per liter (mg/L) Interval -96.2 to 30.2	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants 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 n=126 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in ESR at Week 24	-5 millimeters per hour (mm/hr) Interval -57.0 to 89.0	-15 millimeters per hour (mm/hr) Interval -85.0 to 34.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants 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 n=116 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24 Physical Component Summary	4.21 scores on a scale Standard Error 1.048	6.69 scores on a scale Standard Error 1.031	—
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24 Physical Functioning	3.14 scores on a scale Standard Error 1.125	5.70 scores on a scale Standard Error 1.100	—
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24 Role Physical	5.43 scores on a scale Standard Error 1.259	6.64 scores on a scale Standard Error 1.231	—
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24 Bodily Pain	3.63 scores on a scale Standard Error 1.197	8.28 scores on a scale Standard Error 1.170	—
Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24 General Health	2.28 scores on a scale Standard Error 1.033	4.08 scores on a scale Standard Error 1.011	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants 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 n=116 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24 Mental Component Summary	1.57 scores on a scale Standard Error 1.308	4.60 scores on a scale Standard Error 1.272	—
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24 Vitality	2.46 scores on a scale Standard Error 1.169	7.26 scores on a scale Standard Error 1.154	—
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24 Social Functioning	3.56 scores on a scale Standard Error 1.361	4.98 scores on a scale Standard Error 1.331	—
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24 Role Emotional	2.23 scores on a scale Standard Error 1.612	4.93 scores on a scale Standard Error 1.563	—
Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24 Mental Health	2.92 scores on a scale Standard Error 1.278	5.40 scores on a scale Standard Error 1.249	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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."

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants 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 n=114 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24	2 scores on a scale Interval -37.0 to 27.0	6 scores on a scale Interval -19.0 to 42.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants 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 n=115 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24 Anti-CCP, n=120, 115	0.0 Units/Liter Interval -1613.0 to 4042.0	-138.0 Units/Liter Interval -13000.0 to 762.0	—
Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24 RF-IgA, n=119, 110	0.0 Units/Liter Interval -79.0 to 72.0	-3 Units/Liter Interval -93.0 to 3.0	—
Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24 RF-IgG, n=119, 110	0.0 Units/Liter Interval -71.0 to 58.0	-4.8 Units/Liter Interval -87.0 to 9.0	—
Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24 RF-IgM, n=119, 110	0.0 Units/Liter Interval -68.0 to 98.0	-6.3 Units/Liter Interval -93.0 to 98.0	—

SECONDARY outcome

Timeframe: Baseline and Week 24

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

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

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants 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 n=115 Participants 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).	Placebo or OFA 700 mg: FU 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.
Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24 IL-6, n=119, 115	-0.410 nanogram per liter (ng/l) Interval -131.26 to 2632.66	-4.040 nanogram per liter (ng/l) Interval -106.98 to 63.44	—
Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24 Serum Amyloid A, n=120, 114	-10850.5 nanogram per liter (ng/l) Interval -1680680.0 to 3374580.0	-53513.5 nanogram per liter (ng/l) Interval -3724434.0 to 931790.0	—

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 1, n=0, 243, 0	—	4.01 Scores on a scale Standard Deviation 1.396	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 2, n=0, 198, 0	—	3.59 Scores on a scale Standard Deviation 1.227	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 3, n=0, 136, 0	—	3.36 Scores on a scale Standard Deviation 1.225	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 4, n=0, 72, 0	—	3.50 Scores on a scale Standard Deviation 1.175	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 5, n=0, 31, 0	—	3.34 Scores on a scale Standard Deviation 1.326	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 6, n=0, 11, 0	—	3.82 Scores on a scale Standard Deviation 1.588	—
Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course TC 7, n=0, 2, 0	—	5.34 Scores on a scale Standard Deviation 1.038	—

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 243, 0	—	3.43 scores on a scale Standard Deviation 1.321	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 198, 0	—	3.09 scores on a scale Standard Deviation 1.142	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 136, 0	—	2.86 scores on a scale Standard Deviation 1.156	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 72, 0	—	2.94 scores on a scale Standard Deviation 1.161	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 31, 0	—	2.90 scores on a scale Standard Deviation 1.362	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 11, 0	—	3.39 scores on a scale Standard Deviation 1.401	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, n=0, 2, 0	—	4.55 scores on a scale Standard Deviation 1.003	—

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=238 Participants 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).	Placebo or OFA 700 mg: FU 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.
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 238, 0	—	-2.32 scores on a scale Standard Deviation 1.192	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 194, 0	—	-1.77 scores on a scale Standard Deviation 1.072	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 129, 0	—	-1.77 scores on a scale Standard Deviation 1.203	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 69, 0	—	-1.47 scores on a scale Standard Deviation 1.065	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 31, 0	—	-1.77 scores on a scale Standard Deviation 1.015	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 11, 0	—	-1.45 scores on a scale Standard Deviation 0.845	—
Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, n=0, 2, 0	—	-0.07 scores on a scale Standard Deviation 0.696	—

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=237 Participants 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).	Placebo or OFA 700 mg: FU 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.
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 69, 0	—	-1.40 scores on a scale Standard Deviation 1.081	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 31, 0	—	-1.61 scores on a scale Standard Deviation 1.036	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 11, 0	—	-1.33 scores on a scale Standard Deviation 0.710	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 237, 0	—	-2.15 scores on a scale Standard Deviation 1.166	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 193, 0	—	-1.55 scores on a scale Standard Deviation 1.020	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 125, 0	—	-1.67 scores on a scale Standard Deviation 1.144	—
Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, n=0, 2, 0	—	-0.05 scores on a scale Standard Deviation 0.200	—

SECONDARY outcome

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

Population: AT Population

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Remission, n=0, 243, 0	—	38 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Low Disease Activity, n=0, 243, 0	—	33 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Remission, n=0, 198, 0	—	47 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Low Disease Activity, n=0, 198, 0	—	33 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Remission, n=0, 136, 0	—	40 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Low Disease Activity, n=0, 136, 0	—	31 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Remission, n=0, 72, 0	—	15 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Low Disease Activity, n=0, 72, 0	—	20 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Remission, n=0, 31, 0	—	13 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Low Disease Activity, n=0, 31, 0	—	4 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Remission, n=0, 11, 0	—	3 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Low Disease Activity, n=0, 11, 0	—	1 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Remission, n=0, 2, 0	—	0 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Low Disease Activity, n=0, 2, 0	—	0 participants	—

SECONDARY outcome

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

Population: AT Population

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Remission, n=0, 72, 0	—	30 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Low Disease Activity, n=0, 243, 0	—	44 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Remission, n=0, 243, 0	—	71 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Remission, n=0, 198, 0	—	71 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Low Disease Activity, n=0, 198, 0	—	36 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Remission, n=0, 136, 0	—	63 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Low Disease Activity, n=0, 136, 0	—	21 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Low Disease Activity, n=0, 72, 0	—	11 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Remission,n=0, 31, 0	—	14 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Low Disease Activity,n=0, 31, 0	—	4 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Remission,n=0, 11, 0	—	4 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Low Disease Activity,n=0, 11, 0	—	2 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Remission, n=0, 2, 0	—	0 participants	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Low Disease Activity, n=0, 2, 0	—	0 participants	—

SECONDARY outcome

Timeframe: From Baseline up to Week 144

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=198 Participants 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).	Placebo or OFA 700 mg: FU 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.
Time to Retreatment, by Ofatumumab Treatment Course TC 1, n=0, 198, 0	—	34.26 Weeks Standard Deviation 15.828	—
Time to Retreatment, by Ofatumumab Treatment Course TC 2, n=0, 136, 0	—	34.50 Weeks Standard Deviation 15.151	—
Time to Retreatment, by Ofatumumab Treatment Course TC 3, n=0, 72, 0	—	28.83 Weeks Standard Deviation 10.713	—
Time to Retreatment, by Ofatumumab Treatment Course TC 4, n=0, 31, 0	—	20.82 Weeks Standard Deviation 6.952	—
Time to Retreatment, by Ofatumumab Treatment Course TC 5, n=0, 11, 0	—	19.94 Weeks Standard Deviation 5.411	—
Time to Retreatment, by Ofatumumab Treatment Course TC 6, n=0, 2, 0	—	17.86 Weeks Standard Deviation 0.404	—
Time to Retreatment, by Ofatumumab Treatment Course TC 7, n=0, 0, 0	—	NA Weeks Standard Deviation NA Data are not available because there was no subsequent treatment course after Treatment Course 7.	—

SECONDARY outcome

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

Population: AT Population

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 1, n=0, 243, 0	—	212 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 2, n=0, 198, 0	—	151 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 3, n=0, 136, 0	—	91 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 4, n=0, 72, 0	—	43 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 5, n=0, 31, 0	—	14 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 6, n=0, 11, 0	—	5 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 7, n=0, 2, 0	—	0 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 1, n=0, 243, 0	—	14 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 2, n=0, 198, 0	—	19 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 3, n=0, 136, 0	—	12 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 4, n=0, 72, 0	—	4 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 5, n=0, 31, 0	—	1 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 6, n=0, 11, 0	—	0 Participants	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 7, n=0, 2, 0	—	0 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=237 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 237, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 182, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 177, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 96, 0	—	9 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 59, 0	—	3 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 46, 0	—	9 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 31, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 23, 0	—	7 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 19, 0	—	4 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 15, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 13, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 12, 0	—	4 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 10, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 8, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 7, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 4, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 136, n=0, 4, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 4, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 194, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 177, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 150, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 97, 0	—	7 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 69, 0	—	12 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 58, 0	—	8 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 43, 0	—	13 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 31, 0	—	13 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 24, 0	—	11 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 21, 0	—	12 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 88, n=0, 16, 0	—	7 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 10, 0	—	6 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 104, n=0, 8, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 112, n=0, 4, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 120, n=0, 3, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 128, n=0, 1, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 132, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 119, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 92, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 63, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 35, 0	—	4 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 24, 0	—	7 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 14, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 64, n=0, 10, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 72, n=0, 8, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 80, n=0, 8, 0	—	5 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 88, n=0, 4, 0	—	3 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 96, n=0, 2, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 104, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 70, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 53, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 37, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 25, 0	—	4 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 8, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 2, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 30, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 20, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 20, 0	—	1 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 9, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 3, 0	—	2 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 11, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 10, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 7, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 2, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 8, n=0, 2, 0	—	0 Participants	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 16, n=0, 1, 0	—	0 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=237 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 237, 0	—	197 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 182, 0	—	156 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 177, 0	—	152 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 96, 0	—	88 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 59, 0	—	51 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 46, 0	—	40 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 31, 0	—	26 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 23, 0	—	18 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 19, 0	—	16 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 15, 0	—	13 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 13, 0	—	11 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 12, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 10, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 8, 0	—	7 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 7, 0	—	6 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 136, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 194, 0	—	170 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 177, 0	—	155 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 150, 0	—	128 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 97, 0	—	82 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 69, 0	—	60 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 58, 0	—	48 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 43, 0	—	35 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 31, 0	—	28 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 24, 0	—	20 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 21, 0	—	17 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 88, n=0, 16, 0	—	14 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 10, 0	—	10 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 104, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 112, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 120, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 128, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 132, 0	—	118 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 119, 0	—	105 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 92, 0	—	81 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 63, 0	—	57 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 35, 0	—	32 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 24, 0	—	21 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 14, 0	—	12 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 64, n=0, 10, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 72, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 80, n=0, 8, 0	—	7 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 88, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 96, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 104, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 70, 0	—	66 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 53, 0	—	49 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 37, 0	—	34 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 25, 0	—	23 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 8, 0	—	7 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 30, 0	—	26 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 27, 0	—	24 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 20, 0	—	19 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 9, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 11, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 10, 0	—	9 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 7, 0	—	6 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 8, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 16, n=0, 1, 0	—	1 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=237 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 237, 0	—	209 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 182, 0	—	163 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 177, 0	—	150 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 96, 0	—	89 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 59, 0	—	50 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 46, 0	—	40 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 31, 0	—	26 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 23, 0	—	18 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 19, 0	—	16 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 15, 0	—	14 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 13, 0	—	10 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 12, 0	—	10 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 10, 0	—	9 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 8, 0	—	7 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 7, 0	—	6 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 136, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 194, 0	—	174 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 177, 0	—	162 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 150, 0	—	136 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 97, 0	—	85 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 69, 0	—	63 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 58, 0	—	51 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 43, 0	—	37 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 31, 0	—	29 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 24, 0	—	22 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 21, 0	—	19 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 88, n=0, 16, 0	—	15 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 10, 0	—	10 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 104, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 112, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 120, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 128, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 132, 0	—	120 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 119, 0	—	108 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 92, 0	—	81 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 63, 0	—	58 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 35, 0	—	33 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 24, 0	—	20 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 14, 0	—	13 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 64, n=0, 10, 0	—	8 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 72, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 80, n=0, 8, 0	—	7 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 88, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 96, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 104, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 70, 0	—	68 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 53, 0	—	51 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 37, 0	—	35 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 25, 0	—	24 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 30, 0	—	27 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 27, 0	—	26 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 20, 0	—	18 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 9, 0	—	9 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 11, 0	—	10 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 10, 0	—	9 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 7, 0	—	7 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 8, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 16, n=0, 1, 0	—	1 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=237 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 24, 0	—	24 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 14, 0	—	13 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 237, 0	—	216 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 182, 0	—	166 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 177, 0	—	160 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 96, 0	—	90 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 59, 0	—	51 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 46, 0	—	42 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 31, 0	—	29 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 23, 0	—	19 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 19, 0	—	15 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 15, 0	—	14 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 13, 0	—	12 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 12, 0	—	11 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 10, 0	—	10 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 7, 0	—	6 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 136, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 4, 0	—	3 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 194, 0	—	181 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 177, 0	—	164 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 150, 0	—	140 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 97, 0	—	91 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 69, 0	—	65 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 58, 0	—	54 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 43, 0	—	40 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 31, 0	—	29 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 24, 0	—	23 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 21, 0	—	19 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 88, n=0, 16, 0	—	15 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 10, 0	—	10 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 104, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 112, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 120, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 128, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 132, 0	—	128 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 119, 0	—	113 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 92, 0	—	88 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 63, 0	—	61 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 35, 0	—	34 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 64, n=0, 10, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 72, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 80, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 88, n=0, 4, 0	—	4 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 96, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 104, n=0, 1, 0	—	1 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 70, 0	—	68 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 53, 0	—	52 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 37, 0	—	37 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 25, 0	—	24 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 8, 0	—	8 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 30, 0	—	28 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 27, 0	—	26 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 20, 0	—	20 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 9, 0	—	9 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 3, 0	—	3 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 11, 0	—	10 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 10, 0	—	10 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 7, 0	—	6 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 8, n=0, 2, 0	—	2 Participants	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 7, Week 16, n=0, 1, 0	—	1 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=243 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, PBL, <LLN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, BL, <LLN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, BL, >ULN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, BL, <LLN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, PBL, >ULN, n=0, 136, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, BL, <LLN, n=0, 242, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, PBL, <LLN, n=0, 243, 0	—	2 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, BL, >ULN, n=0, 242, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, PBL, >ULN, n=0, 243, 0	—	3 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, BL, <LLN, n=0, 242, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, PBL, <LLN, n=0, 243, 0	—	15 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, BL, >ULN, n=0, 242, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, PBL, >ULN, n=0, 243, 0	—	15 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, BL, <LLN, n=0, 243, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, PBL, <LLN, n=0, 243, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, BL, >ULN, n=0, 243, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, PBL, >ULN, n=0, 243, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, BL, <LLN, n=0, 196, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, PBL, <LLN, n=0, 198, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, BL, >ULN, n=0, 196, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, PBL, >ULN, n=0, 198, 0	—	2 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, BL, <LLN, n=0, 196, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, PBL, <LLN, n=0, 198, 0	—	9 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, BL, >ULN, n=0, 196, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, PBL, >ULN, n=0, 198, 0	—	12 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, BL, <LLN, n=0, 196, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, PBL, <LLN, n=0, 198, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, BL, >ULN, n=0, 196, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, PBL, <LLN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, PBL, >ULN, n=0, 198, 0	—	2 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, BL, <LLN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, PBL, <LLN, n=0, 136, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, BL, >ULN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, PBL, >ULN, n=0, 136, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, BL, <LLN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, PBL, <LLN, n=0, 136, 0	—	6 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, BL, >ULN, n=0, 136, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, PBL, >ULN, n=0, 136, 0	—	3 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, BL, <LLN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, PBL, <LLN, n=0, 136, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, BL, >ULN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, PBL, >ULN, n=0, 72, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, BL, <LLN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, PBL, <LLN, n=0, 72, 0	—	4 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, BL, >ULN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, PBL, >ULN, n=0, 72, 0	—	2 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, BL, <LLN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, BL, >ULN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, PBL, >ULN, n=0, 72, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, PBL, <LLN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, BL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, PBL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, BL, <LLN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, PBL, <LLN, n=0, 31, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, BL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, PBL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, BL, <LLN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, PBL, <LLN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, BL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, PBL, >ULN, n=0, 31, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, BL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, PBL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, BL, >ULN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, PBL, >ULN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, BL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, PBL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, BL, >ULN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, PBL, >ULN, n=0, 11, 0	—	1 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, BL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, PBL, <LLN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, BL, >ULN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, PBL, >ULN, n=0, 11, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 7, BL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 7, PBL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 7, BL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 7, PBL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 7, BL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 7, PBL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 7, BL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 7, PBL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 7, BL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 7, PBL, <LLN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 7, BL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 7, PBL, >ULN, n=0, 2, 0	—	0 Participants	—

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=225 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, normal, n=0, 225, 0	—	150 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, abnormal CS, n=0, 225, 0	—	2 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, abnormal NCS, n=0, 225, 0	—	71 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, NR, n=0, 225, 0	—	2 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, normal, n=0, 202, 0	—	133 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, abnormal CS, n=0, 202, 0	—	1 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, abnormal NCS, n=0, 202, 0	—	67 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, NR, n=0, 202, 0	—	1 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, normal, n=0, 180, 0	—	119 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, abnormal CS, n=0, 180, 0	—	0 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, abnormal NCS, n=0, 180, 0	—	60 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, NR, n=0, 180, 0	—	1 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, normal, n=0, 167, 0	—	120 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, abnormal CS, n=0, 167, 0	—	1 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, abnormal NCS, n=0, 167, 0	—	46 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, NR, n=0, 167, 0	—	0 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, normal, n=0, 95, 0	—	68 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, abnormal CS, n=0, 95, 0	—	1 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, abnormal NCS, n=0, 95, 0	—	26 Participants	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, NR, n=0, 95, 0	—	0 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=239 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 1, PBL, CC low, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 1, PBL, CC high, n=0, 239, 0	—	3 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 1, PBL, CC high, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 1, PBL, CC high, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 1, PBL, CC high, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, PBL, CC low, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 1, BL, CC low, n=0, 234, 0	—	9 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 1, PBL, CC low, n=0, 239, 0	—	15 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 1, PBL, CC low, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 1, BL, CC high, n=0, 234, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 1, PBL, CC high, n=0, 239, 0	—	4 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 1,PBL, CC high, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 1, BL, CC high, n=0, 234, 0	—	11 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 1, PBL, CC high, n=0, 239, 0	—	9 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 1, BL, CC high, n=0, 234, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 1, PBL, CC high, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, BL, CC high, n=0, 234, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, PBL, CC high, n=0, 239, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, PBL, CC low, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 1, PBL, CC low, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 1, BL, CC low, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 1, PBL, CC low, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 1, PBL, CC high, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 1, BL, CC high, n=0, 234, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 1, PBL, CC high, n=0, 239, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 2, BL, CC low, n=0, 177, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 2, PBL, CC low, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 2, BL, CC high, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 2, PBL, CC high, n=0, 196, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 2, BL, CC high, n=0, 177, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 2, PBL, CC high, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 2, BL, CC high, n=0, 176, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 2, PBL, CC high, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 2, BL, CC high, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 2, PBL, CC high, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, BL, CC low, n=0, 176, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, PBL, CC low, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 2, BL, CC low, n=0, 176, 0	—	5 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 2, PBL, CC low, n=0, 196, 0	—	10 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 2, BL, CC low, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 2, PBL, CC low, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 2, BL, CC high, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 2, PBL, CC high, n=0, 196, 0	—	4 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 2, BL, CC high, n=0, 177, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 2,PBL, CC high, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 2, BL, CC high, n=0, 117, 0	—	3 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 2, PBL, CC high, n=0, 196, 0	—	9 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 2, BL, CC high, n=0, 176, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 2, PBL, CC high, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, BL, CC high, n=0, 176, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, PBL, CC high, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, BL, CC low, n=0, 176, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, PBL, CC low, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 2, BL, CC low, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 2, PBL, CC low, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 2, BL, CC low, n=0, 177, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 2, PBL, CC low, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 2, BL, CC high, n=0, 177, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 2, PBL, CC high, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 2, BL, CC high, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 2, PBL, CC high, n=0, 196, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 3, BL, CC high, n=0, 116, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 3, PBL, CC high, n=0, 135, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 3, BL, CC high, n=0, 116, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 3, PBL, CC high, n=0, 135, 0	—	3 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 3, PBL, CC high, n=0, 135, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 3, PBL, CC high, n=0, 135, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, PBL, CC low, n=0, 134, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 3, BL, CC low, n=0, 116, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 3, PBL, CC low, n=0, 134, 0	—	6 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 3, BL, CC high, n=0, 116, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 3, PBL, CC high, n=0, 135, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 3, PBL, CC high, n=0, 134, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 3, BL, CC high, n=0, 116, 0	—	5 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 3, PBL, CC high, n=0, 134, 0	—	7 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 3, PBL, CC high, n=0, 135, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, PBL, CC high, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, PBL, CC low, n=0, 134, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 3, BL, CC low, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 3, BL, CC high, n=0, 116, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 3, PBL, CC high, n=0, 134, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 3, BL, CC high, n=0, 116, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 3, PBL, CC high, n=0, 134, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 4, BL, CC high, n=0, 67, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 4, PBL, CC high, n=0, 72, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 4, PBL, CC high, n=0, 72, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 4, BL, CC high, n=0, 67, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 4, PBL, CC high, n=0, 72, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 4, BL, CC low, n=0, 67, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 4, PBL, CC low, n=0, 72, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 4, PBL, CC high, n=0, 72, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 4, BL, CC high, n=0, 67, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 4, PBL, CC high, n=0, 72, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 4, BL, CC high, n=0, 67, 0	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 4, PBL, CC high, n=0, 72, 0	—	3 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 4, PBL, CC high, n=0, 72, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 4, BL, CC high, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 5, PBL, CC high, n=0, 31, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 5, PBL, CC high, n=0, 31, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 3, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 5, PBL, CC high, n=0, 31, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 5, PBL, CC high, n=0, 31, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 6, BL, CC high, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, BL, CC low, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 6, BL, CC low, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 6, PBL, CC low, n=0, 11, 0	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Chloride, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 6, BL, CC high, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, BL, CC high, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, BL, CC low, n=0, 10, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course LDH, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Sodium, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Total Protein, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=239 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, PBL, CC low, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, BL, CC low, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, PBL, CC low, n=0, 72, 0	—	5 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, BL, CC high, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4,PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, BL, CC low, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, BL, CC high, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 5, PBL, CC high, n=0, 31, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, BL, CC low, n=0, 29, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5,PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, BL, CC low, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, PBL, CC low, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, BL, CC high, n=0, 29, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, PBL, CC high, n=0, 31, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 6, BL, CC low, n=0, 11, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6,PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, BL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, BL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, PBL, CC high, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, BL, CC high, n=0, 221, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, PBL, CC high, n=0, 239, 0	—	3 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 1, BL, CC low, n=0, 224, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 1, PBL, CC low, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, BL, CC low, n=0, 224, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, PBL, CC low, n=0, 239, 0	—	8 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, BL, CC high, n=0, 224, 0	—	5 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1,PBL, CC high, n=0, 239, 0	—	6 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, BL, CC low, n=0, 224, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, BL, CC high, n=0, 224, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, PBL, CC high, n=0, 239, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 2, BL, CC high, n=0, 171, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 2, PBL, CC high, n=0, 195, 0	—	6 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 2, BL, CC low, n=0, 173, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 2, PBL, CC low, n=0, 195, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 2, BL, CC low, n=0, 172, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 2, PBL, CC low, n=0, 195, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 2, BL, CC low, n=0, 177, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 2, PBL, CC low, n=0, 196, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, BL, CC high, n=0, 170, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, PBL, CC high, n=0, 195, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 2, BL, CC low, n=0, 172, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 2, PBL, CC low, n=0, 195, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, BL, CC low, n=0, 171, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, PBL, CC low, n=0, 195, 0	—	3 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, BL, CC high, n=0, 171, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2,PBL, CC high, n=0, 195, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, BL, CC low, n=0, 171, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, PBL, CC low, n=0, 195, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, BL, CC high, n=0, 171, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, PBL, CC high, n=0, 195, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 3, BL, CC high, n=0, 114, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 3, PBL, CC high, n=0, 134, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 3, BL, CC low, n=0, 115, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 3, BL, CC low, n=0, 115, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 3, BL, CC low, n=0, 117, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, BL, CC high, n=0, 115, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, PBL, CC high, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 3, BL, CC low, n=0, 115, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, BL, CC low, n=0, 114, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, PBL, CC low, n=0, 134, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, BL, CC high, n=0, 114, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3,PBL, CC high, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, BL, CC low, n=0, 114, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, PBL, CC low, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, BL, CC high, n=0, 114, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, PBL, CC high, n=0, 134, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 4, BL, CC high, n=0, 66, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 4, PBL, CC high, n=0, 72, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 4, BL, CC low, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 4, BL, CC low, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 4, BL, CC low, n=0, 67, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 4, PBL, CC low, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, BL, CC high, n=0, 65, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, PBL, CC high, n=0, 72, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 4, BL, CC low, n=0, 66, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 6, PBL, CC low, n=0, 11, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 7, BL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 7,PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 7, BL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 7, PBL, CC low, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 7, PBL, CC high, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 1, BL, CC high, n=0, 224, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 1, PBL, CC high, n=0, 239, 0	—	4 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 1, BL, CC low, n=0, 224, 0	—	0 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 1, PBL, CC low, n=0, 239, 0	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 1, BL, CC low, n=0, 224, 0	—	3 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 1, PBL, CC low, n=0, 239, 0	—	6 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 1, BL, CC low, n=0, 232, 0	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Lymphocytes, TC 1, PBL, CC low, n=0, 239, 0	—	1 Participants	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=205 Participants 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).	Placebo or OFA 700 mg: FU 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.
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 1, PBL, >ULN, n=0, 169, 0	—	93 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 1, BL, >ULN, n=0, 205, 0	—	173 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 1, PBL, >ULN, n=0, 169, 0	—	129 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 1, BL, >ULN, n=0, 207, 0	—	185 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 1, PBL, <LLN, n=0, 206, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 1, BL, >ULN, n=0, 203, 0	—	12 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 1, BL, >ULN, n=0, 205, 0	—	144 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 2, BL, >ULN, n=0, 52, 0	—	18 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 3, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 4, BL, >ULN, n=0, 14, 0	—	6 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 4, BL, >ULN, n=0, 14, 0	—	2 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 4, BL, >ULN, n=0, 14, 0	—	8 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 4, PBL, >ULN, n=0, 45, 0	—	35 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 4, PBL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 1, BL, >ULN, n=0, 205, 0	—	137 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 1, BL, >ULN, n=0, 205, 0	—	114 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 1, PBL, >ULN, n=0, 169, 0	—	67 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 1, PBL, >ULN, n=0, 168, 0	—	140 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 1, BL, <LLN, n=0, 203, 0	—	21 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 1, PBL, >ULN, n=0, 206, 0	—	167 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 1, PBL, >ULN, n=0, 138, 0	—	79 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 1, BL, >ULN, n=0, 204, 0	—	129 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 1, PBL, >ULN, n=0, 138, 0	—	68 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 2, BL, >ULN, n=0, 59, 0	—	32 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 2, PBL, >ULN, n=0, 111, 0	—	51 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 2, BL, >ULN, n=0, 59, 0	—	20 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 2, PBL, >ULN, n=0, 111, 0	—	38 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 2, BL, >ULN, n=0, 59, 0	—	45 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 2, PBL, >ULN, n=0, 111, 0	—	80 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 2, BL, >ULN, n=0, 60, 0	—	51 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 2, PBL, >ULN, n=0, 111, 0	—	93 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 2, BL, <LLN, n=0, 81, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 2, PBL, <LLN, n=0, 88, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 2, BL, >ULN, n=0, 81, 0	—	60 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 2, PBL, >ULN, n=0, 88, 0	—	72 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 2, BL, >ULN, n=0, 52, 0	—	23 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 2, PBL, >ULN, n=0, 23, 0	—	8 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 2, PBL, >ULN, n=0, 24, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 3, BL, >ULN, n=0, 20, 0	—	9 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 3, PBL, >ULN, n=0, 95, 0	—	42 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 3, BL, >ULN, n=0, 20, 0	—	7 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 3, PBL, >ULN, n=0, 95, 0	—	21 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 3, BL, >ULN, n=0, 20, 0	—	14 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 3, PBL, >ULN, n=0, 95, 0	—	61 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 3, BL, >ULN, n=0, 20, 0	—	16 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 3, PBL, >ULN, n=0, 94, 0	—	78 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 3, BL, <LLN, n=0, 16, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 3, PBL, <LLN, n=0, 4, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 3, BL, >ULN, n=0, 16, 0	—	14 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 3, PBL, >ULN, n=0, 4, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 3, PBL, >ULN, n=0, 21, 0	—	9 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 3, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 3, PBL, >ULN, n=0, 21, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 4, PBL, >ULN, n=0, 43, 0	—	19 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 4, PBL, >ULN, n=0, 43, 0	—	13 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 4, PBL, >ULN, n=0, 43, 0	—	27 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 4, BL, >ULN, n=0, 14, 0	—	10 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 4, BL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 4, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 4, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 4, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 4, PBL, >ULN, n=0, 18, 0	—	5 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 4, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 4, PBL, >ULN, n=0, 17, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 5, BL, >ULN, n=0, 5, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 5, PBL, >ULN, n=0, 24, 0	—	10 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 5, BL, >ULN, n=0, 5, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 5, PBL, >ULN, n=0, 24, 0	—	5 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 5, BL, >ULN, n=0, 5, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 5, PBL, >ULN, n=0, 24, 0	—	17 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 5, BL, >ULN, n=0, 5, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 5, PBL, >ULN, n=0, 24, 0	—	20 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 5, BL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 5, PBL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 5, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 5, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 5, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 5, PBL, >ULN, n=0, 5, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 5, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 5, PBL, >ULN, n=0, 5, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 6, BL, >ULN, n=0, 6, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 6, PBL, >ULN, n=0, 9, 0	—	3 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 6, BL, >ULN, n=0, 6, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 6, PBL, >ULN, n=0, 9, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 6, BL, >ULN, n=0, 6, 0	—	3 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 6, PBL, >ULN, n=0, 9, 0	—	6 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 6, BL, >ULN, n=0, 6, 0	—	4 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 6, PBL, >ULN, n=0, 9, 0	—	8 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 6, BL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 6, PBL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 6, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 6, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 6, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 6, PBL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 6, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 6, PBL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 7, BL, >ULN, n=0, 2, 0	—	2 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgA, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 7, BL, >ULN, n=0, 2, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgG, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 7, BL, >ULN, n=0, 2, 0	—	1 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) RF IgM, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 7, BL, >ULN, n=0, 2, 0	—	2 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Anti-CCP, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 7, BL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 7, PBL, <LLN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 7, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) B-ls, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Il-6, TC 7, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) IL-6, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 7, BL, >ULN, n=0, 0, 0	—	0 Participants	—
Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC) Serum amyloid A, TC 7, PBL, >ULN, n=0, 0, 0	—	0 Participants	—

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=224 Participants 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.
Number of Participants With Any Serious Adverse Event During the Follow-up Period	—	—	13 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=220 Participants 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.
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgA <LLN	—	—	1 Participants
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgA >ULN	—	—	29 Participants
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgG <LLN	—	—	16 Participants
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgG >ULN	—	—	20 Participants
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgM <LLN	—	—	35 Participants
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgM >ULN	—	—	7 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=133 Participants 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.
Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab Relative to first dose, n=0, 0, 133	—	—	22.998 Months Interval 0.43 to 56.64
Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab Relative to last dose, n=0, 0, 128	—	—	13.832 Months Interval 3.06 to 54.77

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=243 Participants 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.
Number of Participants With a Positive JC Virus Test Result During the Follow-up Period	—	—	8 Participants

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=224 Participants 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.
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period ALT	—	—	1 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period ALP	—	—	1 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period CK	—	—	2 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period CO2/BCO	—	—	3 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period GGT	—	—	5 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period Creatinine	—	—	1 Participants
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period Urea/BUN	—	—	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Placebo or OFA 700 mg: FU Period n=224 Participants 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.
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Eosinophils	—	—	1 Participants
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Total neutrophils	—	—	2 Participants
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Platelet count	—	—	1 Participants

Adverse Events

Placebo: DB Period

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Ofatumumab 700 mg: DB and OL Periods

Serious events: 44 serious events

Other events: 226 other events

Deaths: 0 deaths

Placebo or Ofatumumab 700 mg: Follow-up Period

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER