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

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ClinicalTrials.gov Identifier: NCT00603525
Recruitment Status : Terminated (Ofatumumab IV trials in RA were prematurely terminated because GSK refocused clinical development of autoimmune indications on the subcutaneous delivery.)
First Posted : January 29, 2008
Results First Posted : November 28, 2011
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: Ofatumumab
Drug: Placebo
Enrollment 169
Recruitment Details  
Pre-assignment Details Study OFA110634 is comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who complete the OL Period, or who are withdrawn, enter a Follow-up (FU) period (anticipated to be approximately 2 years).
Arm/Group Title Placebo Ofatumumab Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course). Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
Period Title: DB Treatment Period (24 Weeks)
Started 84 85 0
Completed 67 63 0
Not Completed 17 22 0
Reason Not Completed
Adverse Event             3             9             0
Lack of Efficacy             7             0             0
Protocol Violation             1             2             0
Lost to Follow-up             1             3             0
Withdrawal by Subject             5             6             0
Physician Decision             0             1             0
Participant Met Stopping Criteria             0             1             0
Period Title: OL Treatment Period (120 Weeks)
Started 0 125 [1] 0
Completed 0 13 0
Not Completed 0 112 0
Reason Not Completed
Adverse Event             0             12             0
Lack of Efficacy             0             13             0
Protocol Violation             0             1             0
Protocol-defined Stopping Criteria Met             0             5             0
Study Closed/Terminated             0             71             0
Physician Decision             0             2             0
Withdrawal by Subject             0             8             0
[1]
61 participants received OFA during the DB Period; 64 received placebo during the DB Period.
Period Title: Follow-up Period (Approximately 2 Years)
Started 0 0 124 [1]
Unknown Reason for Withdrawal 0 0 111 [2]
Completed 0 0 13
Not Completed 0 0 111
Reason Not Completed
Unknown Reason for Withdrawal             0             0             111
[1]
124 participants (par) completing/withdrawing from the DB or OL Periods attended >=1 follow-up visit
[2]
As par. were not on active drug during the Follow-up Period, withdrawal reasons were not collected.
Arm/Group Title Placebo Ofatumumab 700 mg Total
Hide Arm/Group Description Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks). Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks). Total of all reporting groups
Overall Number of Baseline Participants 84 85 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 85 participants 169 participants
53.3  (11.69) 53.7  (13.64) 53.5  (12.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 85 participants 169 participants
Female
67
  79.8%
73
  85.9%
140
  82.8%
Male
17
  20.2%
12
  14.1%
29
  17.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 85 participants 169 participants
Hispanic/Latino 35 35 70
Not Hispanic/Latino 49 50 99
1.Primary Outcome
Title Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24
Hide Description The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
16 36
2.Secondary Outcome
Title Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20
Hide Description The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame Baseline and Weeks 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
Week 4 22 25
Week 8 23 29
Week 12 30 36
Week 16 23 36
Week 20 21 40
3.Secondary Outcome
Title Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24
Hide Description The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
Week 4 9 4
Week 8 8 9
Week 12 11 17
Week 16 10 17
Week 20 8 18
Week 24 5 19
4.Secondary Outcome
Title Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24
Hide Description The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
Week 4 3 0
Week 8 2 3
Week 12 3 5
Week 16 3 5
Week 20 3 5
Week 24 3 6
5.Secondary Outcome
Title Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 80 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=80, 73 5.00  (1.492) 5.02  (1.361)
Week 8, n=74, 73 4.96  (1.352) 4.60  (1.300)
Week 12, n=73, 71 4.86  (1.537) 4.16  (1.194)
Week 16, n=69, 71 4.88  (1.526) 4.17  (1.273)
Week 20, n=67, 68 4.91  (1.505) 4.04  (1.262)
Week 24, n=68, 67 5.21  (1.324) 4.22  (1.432)
6.Secondary Outcome
Title Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 80 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=80, 73 -0.83  (1.237) -0.89  (1.094)
Week 8, n=74, 73 -0.81  (1.127) -1.22  (1.142)
Week 12, n=73, 71 -0.92  (1.382) -1.64  (1.242)
Week 16, n=69, 71 -0.86  (1.362) -1.64  (1.318)
Week 20, n=67, 68 -0.79  (1.270) -1.75  (1.311)
Week 24, n=68, 67 -0.51  (1.142) -1.56  (1.370)
7.Secondary Outcome
Title Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 80 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=80, 74 5.84  (1.455) 5.80  (1.390)
Week 8, n=74, 72 5.76  (1.327) 5.41  (1.335)
Week 12, n=73, 71 5.60  (1.498) 4.99  (1.269)
Week 16, n=69, 71 5.66  (1.481) 4.95  (1.356)
Week 20, n=67, 68 5.74  (1.539) 4.79  (1.312)
Week 24, n=68, 67 5.96  (1.358) 5.03  (1.537)
8.Secondary Outcome
Title Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 80 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=80, 74 -0.85  (1.210) -0.98  (1.105)
Week 8, n=74, 72 -0.88  (1.117) -1.28  (1.165)
Week 12, n=73, 71 -1.05  (1.332) -1.70  (1.304)
Week 16, n=69, 71 -0.95  (1.353) -1.75  (1.350)
Week 20, n=67, 68 -0.85  (1.299) -1.89  (1.299)
Week 24, n=68, 67 -0.63  (1.211) -1.64  (1.473)
9.Secondary Outcome
Title Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant
Hide Description The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
Week 4, Good 15 8
Week 4, Moderate 18 25
Week 4, None 47 40
Week 8, Good 11 11
Week 8, Moderate 23 31
Week 8, None 40 31
Week 12, Good 13 14
Week 12, Moderate 22 39
Week 12, None 38 18
Week 16, Good 9 17
Week 16, Moderate 23 33
Week 16, None 37 21
Week 20, Good 10 18
Week 20, Moderate 21 32
Week 20, None 36 18
Week 24, Good 6 15
Week 24, Moderate 19 29
Week 24, None 43 23
10.Secondary Outcome
Title Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant
Hide Description The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 84 85
Measure Type: Number
Unit of Measure: participants
Week 4, Good 3 4
Week 4, Moderate 29 21
Week 4, None 48 49
Week 8, Good 2 5
Week 8, Moderate 28 33
Week 8, None 44 34
Week 12, Good 2 7
Week 12, Moderate 36 41
Week 12, None 35 23
Week 16, Good 3 6
Week 16, Moderate 29 43
Week 16, None 37 22
Week 20, Good 1 5
Week 20, Moderate 27 46
Week 20, None 39 17
Week 24, Good 2 6
Week 24, Moderate 20 37
Week 24, None 46 24
11.Secondary Outcome
Title Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24
Hide Description ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24
Hide Description The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 75 72
Median (Full Range)
Unit of Measure: scores on a scale
Week 4, n=75, 72
-0.13
(-1.9 to 0.8)
-0.13
(-1.9 to 1.4)
Week 8, n=69, 68
-0.25
(-2.1 to 1.1)
-0.38
(-1.6 to 0.9)
Week 12, n=68, 65
-0.13
(-2.3 to 1.0)
-0.38
(-1.9 to 1.0)
Week 16, n=65, 64
-0.13
(-2.1 to 1.0)
-0.38
(-2.0 to 0.5)
Week 20, n=64, 64
-0.13
(-2.3 to 1.1)
-0.38
(-2.1 to 1.3)
Week 24, n=63, 61
0.00
(-2.3 to 1.0)
-0.38
(-2.1 to 1.5)
13.Secondary Outcome
Title Change From Baseline in Tender Joint Count at Week 24
Hide Description Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 68 66
Median (Full Range)
Unit of Measure: tender joints
-5
(-46 to 23)
-11
(-56 to 14)
14.Secondary Outcome
Title Change From Baseline in Swollen Joint Count at Week 24
Hide Description Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 68 66
Median (Full Range)
Unit of Measure: swollen joints
-3.50
(-27 to 37)
-7.50
(-27 to 33)
15.Secondary Outcome
Title Change From Baseline in CRP at Week 24
Hide Description Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 66 66
Median (Full Range)
Unit of Measure: milligrams per liter (mg/L)
1.05
(-51.5 to 94.0)
-2.85
(-150.6 to 41.4)
16.Secondary Outcome
Title Change From Baseline in ESR at Week 24
Hide Description ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 67 67
Median (Full Range)
Unit of Measure: millimeters per hour (mm/hr)
0.00
(-73 to 52)
-12.00
(-100 to 45)
17.Secondary Outcome
Title Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24
Hide Description A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the "no pain" end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24
Hide Description The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24
Hide Description The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24
Hide Description The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating "Not at all fatigued," to 4, indicating "Very much fatigued."
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24
Hide Description The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24
Hide Description The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4
Hide Description The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing values at the relevant visit were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 81 82
Median (Full Range)
Unit of Measure: Units/Liter
Anti-CCP, Baseline, n=81, 82
466
(8 to 10828)
449.5
(8 to 8261)
RF-IgA, Baseline, n=81, 81
9
(2.5 to 100)
11
(2.5 to 100)
RF-IgA, Week 4, n=0, 1
NA [1] 
(NA to NA)
100
(100 to 100)
IgG, Baseline, n=81, 81
5
(2.5 to 100)
2.5
(2.5 to 100)
IgG, Week4, n=0, 1
NA [1] 
(NA to NA)
5
(5 to 5)
RF-IgM, Baseline, n=81, 81
92
(2.5 to 100)
68
(2.5 to 100)
RF-IgM, Week 4, n=0, 1
NA [1] 
(NA to NA)
43
(43 to 43)
[1]
No participants were analyzed at this time point.
24.Secondary Outcome
Title Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24
Hide Description Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24
Hide Description The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.
Time Frame Baseline, Week 12, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.
Arm/Group Title Placebo Ofatumumab 700 mg
Hide Arm/Group Description:
Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
Overall Number of Participants Analyzed 79 75
Median (Full Range)
Unit of Measure: grams per Liter (g/L)
IgA, Week 12; n=79, 75
-0.020
(-1.72 to 1.47)
-0.250
(-2.32 to 0.65)
IgA, Week 24; n=69, 68
0.050
(-1.51 to 1.47)
-0.350
(-2.58 to 0.81)
IgG, Week 12; n=79, 75
-0.400
(-7.30 to 7.20)
-1.300
(-7.60 to 2.10)
IgG, Week 24; n=69, 68
-0.700
(-8.30 to 8.30)
-1.615
(-9.70 to 4.80)
IgM, Week 12; n=79, 75
-0.040
(-1.58 to 0.75)
-0.260
(-2.92 to 0.17)
IgM, Week 24; n=69, 68
-0.050
(-1.30 to 1.47)
-0.355
(-4.12 to 0.40)
26.Secondary Outcome
Title Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 148 0
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
TC 1, n=0, 148, 0 4.64  (1.511)
TC 2, n=0, 92, 0 4.08  (1.129)
TC 3, n=0, 62, 0 4.09  (1.346)
TC 4, n=0, 29, 0 3.84  (1.437)
TC 5, n=0, 13, 0 3.95  (1.327)
TC 6, n=0, 6, 0 3.33  (1.245)
27.Secondary Outcome
Title Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 147 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 147, 0 3.86  (1.443)
TC 2, n=0, 92, 0 3.37  (1.120)
TC 3, n=0, 62, 0 3.35  (1.181)
TC 4, n=0, 29, 0 3.15  (1.214)
TC 5, n=0, 13, 0 3.23  (1.129)
TC 6, n=0, 6, 0 2.84  (1.193)
28.Secondary Outcome
Title Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 134 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 134, 0 -2.04  (1.348)
TC 2, n=0, 90, 0 -1.70  (1.090)
TC 3, n=0, 59, 0 -1.52  (1.052)
TC 4, n=0, 28, 0 -1.76  (1.499)
TC 5, n=0, 12, 0 -1.50  (1.052)
TC 6, n=0, 6, 0 -2.39  (0.581)
29.Secondary Outcome
Title Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 134 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 134, 0 -1.93  (1.297)
TC 2, n=0, 92, 0 -1.65  (1.086)
TC 3, n=0, 61, 0 -1.44  (1.006)
TC 4, n=0, 28, 0 -1.65  (1.378)
TC 5, n=0, 12, 0 -1.46  (1.006)
TC 6, n=0, 6, 0 -2.20  (0.610)
30.Secondary Outcome
Title Time to Retreatment, by Ofatumumab Treatment Course
Hide Description Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.
Time Frame From Baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 93 0
Mean (Standard Deviation)
Unit of Measure: Days
TC 1, n=0, 93, 0 32.79  (12.031)
TC 2, n=0, 63, 0 28.62  (11.108)
TC 3, n=0, 30, 0 24.56  (8.127)
TC 4, n=0, 13, 0 23.93  (6.143)
TC 5, n=0, 6, 0 19.07  (2.795)
TC 6, n=0, 0, 0 NA [1]   (NA)
[1]
No participants were analyzed in this treatment group for Treatment Course 6.
31.Secondary Outcome
Title Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 148 0
Measure Type: Number
Unit of Measure: participants
TC 1, Remission, n=0, 148, 0 15
TC 1, Low Disease Activity, n=0, 148 7
TC 2, Remission, n=0, 93, 0 5
TC 2, Low Disease Activity, n=0, 93, 0 20
TC 3, Remission, n=0, 63, 0 8
TC 3, Low Disease Activity, n=0, 63, 0 8
TC 4, Remission, n=0, 30, 0 6
TC 4, Low Disease Activity, n=0, 30, 0 5
TC 5, Remission, n=0, 13, 0 2
TC 5, Low Disease Activity, n=0, 13, 0 2
TC 6, Remission, n=0, 6, 0 2
TC 6, Low Disease Activity, n=0, 6, 0 2
32.Secondary Outcome
Title Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.
Time Frame First 24 weeks of each treatment course (assessed up to Week 144)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 148 0
Measure Type: Number
Unit of Measure: participants
TC 1, Remission, n=0, 148, 0 27
TC 1, Low Disease Activity, n=0, 148, 0 26
TC 2, Remission, n=0, 93, 0 24
TC 2, Low Disease Activity, n=0, 93, 0 17
TC 3, Remission, n=0, 63, 0 19
TC 3, Low Disease Activity, n=0, 63, 0 10
TC 4, Remission, n=0, 30, 0 10
TC 4, Low Disease Activity, n=0, 30, 0 5
TC 5, Remission,n=0, 13, 0 5
TC 5, Low Disease Activity,n=0, 13, 0 1
TC 6, Remission,n=0, 6, 0 3
TC 6, Low Disease Activity,n=0, 6, 0 2
33.Secondary Outcome
Title Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.
Time Frame First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 148 0
Measure Type: Number
Unit of Measure: Participants
Any AE, TC 1, n=0, 148, 0 126
Any AE, TC 2, n=0, 93, 0 60
Any AE, TC 3, n=0, 63, 0 36
Any AE, TC 4, n=0, 30, 0 17
Any AE, TC 5, n=0, 13, 0 8
Any AE, TC 6, n=0, 6, 0 5
Any SAE, TC 1, n=0, 148, 0 20
Any SAE, TC 2, n=0, 93, 0 10
Any SAE, TC 3, n=0, 63, 0 2
Any SAE, TC 4, n=0, 30, 0 0
Any SAE, TC 5, n=0, 13, 0 0
Any SAE, TC 6, n=0, 6, 0 0
34.Secondary Outcome
Title Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period
Hide Description The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.
Time Frame From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 117 0
Measure Type: Number
Unit of Measure: Participants
Week 48, normal, n=0, 117, 0 81
Week 48, abnormal CS, n=0, 117, 0 0
Week 48, abnormal NCS, n=0, 117, 0 34
Week 48, NR, n=0, 117, 0 2
Week 72, normal, n=0, 87, 0 59
Week 72, abnormal CS, n=0, 87, 0 0
Week 72, abnormal NCS, n=0, 87, 0 25
Week 72, NR, n=0, 87, 0 3
Week 96, normal, n=0, 57, 0 40
Week 96, abnormal CS, n=0, 57, 0 0
Week 96, abnormal NCS, n=0, 57, 0 16
Week 96, NR, n=0, 57, 0 1
Week 120, normal, n=0, 33, 0 16
Week 120, abnormal CS, n=0, 33, 0 0
Week 120, abnormal NCS, n=0, 33, 0 17
Week 120, NR, n=0, 33, 0 0
Week 144, normal, n=0, 17, 0 10
Week 144, abnormal CS, n=0, 17, 0 0
Week 144, abnormal NCS, n=0, 17, 0 7
Week 144, NR, n=0, 17, 0 0
35.Secondary Outcome
Title Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 136 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 136, 0 0
TC 1, Week 16, n=0, 100, 0 0
TC 1, Week 24, n=0, 99, 0 2
TC 1, Week 32, n=0, 50, 0 1
TC 1, Week 40, n=0, 30, 0 3
TC 1, Week 48, n=0, 23, 0 1
TC 1, Week 56, n=0, 14, 0 3
TC 1, Week 64, n=0, 7, 0 1
TC 1, Week 72, n=0, 4, 0 0
TC 1, Week 80, n=0, 1, 0 0
TC 1, Week 88, n=0, 1, 0 0
TC 1, Week 96, n=0, 1, 0 0
TC 1, Week 104, n=0, 2, 0 1
TC 1, Week 112, n=0, 1, 0 0
TC 1, Week 120, n=0, 1, 0 0
TC 1, Week 128, n=0, 1, 0 0
TC 1, Week 144, n=0, 1, 0 0
TC 2, Week 8, n=0, 93, 0 0
TC 2, Week 16, n=0, 80, 0 1
TC 2, Week 24, n=0, 70, 0 0
TC 2, Week 32, n=0, 31, 0 2
TC 2, Week 40, n=0, 20, 0 2
TC 2, Week 48, n=0, 11, 0 1
TC 2, Week 56, n=0, 8, 0 0
TC 2, Week 64, n=0, 6, 0 1
TC 2, Week 72, n=0, 2, 0 0
TC 2, Week 80, n=0, 2, 0 0
TC 2, Week 96, n=0, 1, 0 0
TC 3, Week 8, n=0, 60, 0 0
TC 3, Week 16, n=0, 45, 0 0
TC 3, Week 24, n=0, 29, 0 0
TC 3, Week 32, n=0, 12, 0 1
TC 3, Week 40, n=0, 4, 0 0
TC 3, Week 48, n=0, 2, 0 1
TC 3, Week 56, n=0, 1, 0 1
TC 4, Week 8, n=0, 29, 0 0
TC 4, Week 16, n=0, 24, 0 0
TC 4, Week 24, n=0, 13, 0 0
TC 4, Week 32, n=0, 4, 0 0
TC 4, Week 40, n=0, 1, 0 0
TC 4, Week 48, n=0, 1, 0 0
TC 5, Week 8, n=0, 13, 0 0
TC 5, Week 16, n=0, 8, 0 0
TC 5, Week 24, n=0, 5, 0 0
TC 5, Week 32, n=0, 5, 0 0
TC 5, Week 40, n=0, 1, 0 0
TC 6, Week 8, n=0, 6, 0 0
TC 6, Week 16, n=0, 6, 0 0
TC 6, Week 24, n=0, 5, 0 0
TC 6, Week 32, n=0, 3, 0 0
36.Secondary Outcome
Title Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 136 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 136, 0 115
TC 1, Week 16, n=0, 100, 0 79
TC 1, Week 24, n=0, 99, 0 75
TC 1, Week 32, n=0, 50, 0 44
TC 1, Week 40, n=0, 30, 0 27
TC 1, Week 48, n=0, 23, 0 21
TC 1, Week 56, n=0, 14, 0 11
TC 1, Week 64, n=0, 7, 0 7
TC 1, Week 72, n=0, 4, 0 4
TC 1, Week 80, n=0, 1, 0 1
TC 1, Week 88, n=0, 1, 0 1
TC 1, Week 96, n=0, 1, 0 1
TC 1, Week 104, n=0, 2, 0 2
TC 1, Week 112, n=0, 1, 0 1
TC 1, Week 120, n=0, 1, 0 1
TC 1, Week 128, n=0, 1, 0 1
TC 1, Week 144, n=0, 1, 0 1
TC 2, Week 8, n=0, 93, 0 78
TC 2, Week 16, n=0, 80, 0 70
TC 2, Week 24, n=0, 70, 0 58
TC 2, Week 32, n=0, 31, 0 29
TC 2, Week 40, n=0, 20, 0 16
TC 2, Week 48, n=0, 11, 0 9
TC 2, Week 56, n=0, 8, 0 7
TC 2, Week 64, n=0, 6, 0 4
TC 2, Week 72, n=0, 2, 0 2
TC 2, Week 80, n=0, 2, 0 2
TC 2, Week 96, n=0, 1, 0 1
TC 3, Week 8, n=0, 60, 0 49
TC 3, Week 16, n=0, 45, 0 36
TC 3, Week 24, n=0, 29, 0 22
TC 3, Week 32, n=0, 12, 0 10
TC 3, Week 40, n=0, 4, 0 2
TC 3, Week 48, n=0, 2, 0 1
TC 3, Week 56, n=0, 1, 0 1
TC 4, Week 8, n=0, 29, 0 24
TC 4, Week 16, n=0, 24, 0 20
TC 4, Week 24, n=0, 13, 0 11
TC 4, Week 32, n=0, 4, 0 3
TC 4, Week 40, n=0, 1, 0 1
TC 4, Week 48, n=0, 1, 0 1
TC 5, Week 8, n=0, 13, 0 10
TC 5, Week 16, n=0, 8, 0 7
TC 5, Week 24, n=0, 5, 0 4
TC 5, Week 32, n=0, 5, 0 4
TC 5, Week 40, n=0, 1, 0 1
TC 6, Week 8, n=0, 6, 0 5
TC 6, Week 16, n=0, 6, 0 5
TC 6, Week 24, n=0, 5, 0 5
TC 6, Week 32, n=0, 3, 0 3
37.Secondary Outcome
Title Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 136 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 136, 0 118
TC 1, Week 16, n=0, 100, 0 83
TC 1, Week 24, n=0, 99, 0 80
TC 1, Week 32, n=0, 50, 0 45
TC 1, Week 40, n=0, 30, 0 27
TC 1, Week 48, n=0, 23, 0 21
TC 1, Week 56, n=0, 14, 0 13
TC 1, Week 64, n=0, 7, 0 7
TC 1, Week 72, n=0, 4, 0 4
TC 1, Week 80, n=0, 1, 0 1
TC 1, Week 88, n=0, 1, 0 1
TC 1, Week 96, n=0, 1, 0 1
TC 1, Week 104, n=0, 2, 0 2
TC 1, Week 112, n=0, 1, 0 1
TC 1, Week 120, n=0, 1, 0 1
TC 1, Week 128, n=0, 1, 0 1
TC 1, Week 144, n=0, 1, 0 1
TC 2, Week 8, n=0, 93, 0 81
TC 2, Week 16, n=0, 80, 0 67
TC 2, Week 24, n=0, 70, 0 62
TC 2, Week 32, n=0, 31, 0 29
TC 2, Week 40, n=0, 20, 0 16
TC 2, Week 48, n=0, 11, 0 9
TC 2, Week 56, n=0, 8, 0 7
TC 2, Week 64, n=0, 6, 0 4
TC 2, Week 72, n=0, 2, 0 2
TC 2, Week 80, n=0, 2, 0 2
TC 2, Week 96, n=0, 1, 0 1
TC 3, Week 8, n=0, 60, 0 49
TC 3, Week 16, n=0, 45, 0 36
TC 3, Week 24, n=0, 29, 0 23
TC 3, Week 32, n=0, 12, 0 11
TC 3, Week 40, n=0, 4, 0 3
TC 3, Week 48, n=0, 2, 0 2
TC 3, Week 56, n=0, 1, 0 1
TC 4, Week 8, n=0, 29, 0 26
TC 4, Week 16, n=0, 24, 0 20
TC 4, Week 24, n=0, 13, 0 11
TC 4, Week 32, n=0, 4, 0 3
TC 4, Week 40, n=0, 1, 0 1
TC 4, Week 48, n=0, 1 1
TC 5, Week 8, n=0, 13, 0 12
TC 5, Week 16, n=0, 8, 0 8
TC 5, Week 24, n=0, 5, 0 5
TC 5, Week 32, n=0, 5, 0 5
TC 5, Week 40, n=0, 1, 0 1
TC 6, Week 8, n=0, 6, 0 5
TC 6, Week 16, n=0, 6, 0 6
TC 6, Week 24, n=0, 5, 0 5
TC 6, Week 32, n=0, 3, 0 3
38.Secondary Outcome
Title Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 136 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 136, 0 121
TC 1, Week 16, n=0, 100, 0 86
TC 1, Week 24, n=0, 99, 0 87
TC 1, Week 32, n=0, 50, 0 47
TC 1, Week 40, n=0, 30, 0 27
TC 1, Week 48, n=0, 23, 0 20
TC 1, Week 56, n=0, 14, 0 13
TC 1, Week 64, n=0, 7, 0 7
TC 1, Week 72, n=0, 4, 0 4
TC 1, Week 80, n=0, 1, 0 1
TC 1, Week 88, n=0, 1, 0 1
TC 1, Week 96, n=0, 1, 0 1
TC 1, Week 104, n=0, 2, 0 2
TC 1, Week 112, n=0, 1, 0 1
TC 1, Week 120, n=0, 1, 0 1
TC 1, Week 128, n=0, 1, 0 1
TC 1, Week 144, n=0, 1, 0 1
TC 2, Week 8, n=0, 93, 0 82
TC 2, Week 16, n=0, 80, 0 74
TC 2, Week 24, n=0, 70, 0 63
TC 2, Week 32, n=0, 31, 0 29
TC 2, Week 40, n=0, 20, 0 19
TC 2, Week 48, n=0, 11, 0 11
TC 2, Week 56, n=0, 8, 0 7
TC 2, Week 64, n=0, 6, 0 5
TC 2, Week 72, n=0, 2, 0 2
TC 2, Week 80, n=0, 2, 0 2
TC 2, Week 96, n=0, 1, 0 1
TC 3, Week 8, n=0, 60, 0 54
TC 3, Week 16, n=0, 45, 0 43
TC 3, Week 24, n=0, 29, 0 24
TC 3, Week 32, n=0, 12, 0 12
TC 3, Week 40, n=0, 4, 0 3
TC 3, Week 48, n=0, 2, 0 1
TC 3, Week 56, n=0, 1, 0 1
TC 4, Week 8, n=0, 29, 0 26
TC 4, Week 16, n=0, 24, 0 23
TC 4, Week 24, n=0, 13, 0 13
TC 4, Week 32, n=0, 4, 0 4
TC 4, Week 40, n=0, 1, 0 1
TC 4, Week 48, n=0, 1, 0 1
TC 5, Week 8, n=0, 13, 0 13
TC 5, Week 16, n=0, 8, 0 8
TC 5, Week 24, n=0, 5, 0 5
TC 5, Week 32, n=0, 5, 0 5
TC 5, Week 40, n=0, 1, 0 1
TC 6, Week 8, n=0, 6, 0 5
TC 6, Week 16, n=0, 6, 0 5
TC 6, Week 24, n=0, 5, 0 5
TC 6, Week 32, n=0, 3, 0 2
39.Secondary Outcome
Title Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 144 0
Measure Type: Number
Unit of Measure: Participants
Albumin, TC 1, BL, CC low, n=0, 144, 0 1
Albumin, TC 1, PBL, CC low, n=0, 136, 0 1
ALT, TC 1, BL, CC high, n=0, 144, 0 1
ALT, TC 1, PBL, CC high, n=0, 136, 0 6
ALP, TC 1, BL, CC high, n=0, 144, 0 0
ALP, TC 1, PBL, CC high, n=0, 136, 0 4
AST, TC 1, BL, CC high, n=0, 142, 0 0
AST, TC 1, PBL, CC high, n=0, 136, 0 2
TBIL, TC 1, BL, CC high, n=0, 144, 0 0
TBIL, TC 1, PBL, CC high, n=0, 136, 0 0
Calcium, TC 1, BL, CC low, n=0, 142, 0 0
Calcium, TC 1, PBL, CC low, n=0, 136, 0 2
Calcium, TC 1, BL, CC high, n=0, 142, 0 0
Calcium, TC 1, PBL, CC high, n=0, 136, 0 0
CO2/BCO, TC 1, BL, CC low, n=0, 142, 0 5
CO2/BCO, TC 1, PBL, CC low, n=0, 136, 0 9
CK, TC 1, BL, CC high, n=0, 144, 0 0
CK, TC 1, PBL, CC high, n=0, 136, 0 1
Creatinine, TC 1, BL, CC high, n=0, 144, 0 0
Creatinine, TC 1,PBL, CC high, n=0, 136, 0 1
GGT, TC 1, BL, CC high, n=0, 144, 0 7
GGT, TC 1, PBL, CC high, n=0, 136, 0 8
Potassium, TC 1, BL, CC high, n=0, 142, 0 2
Potassium, TC 1, PBL, CC high, n=0, 136, 0 0
Potassium, TC 1, BL, CC low, n=0, 142, 0 1
Potassium, TC 1, PBL, CC low, n=0, 136, 0 1
Urea/BUN, TC 1, BL, CC high, n=0, 144, 0 2
Urea/BUN, TC 1, PBL, CC high, n=0, 136, 0 3
Uric acid, TC 1, BL, CC high, n=0, 144, 0 0
Uric acid, TC 1, PBL, CC high, n=0, 136, 0 0
Albumin, TC 2, BL, CC low, n=0, 85, 0 0
Albumin, TC 2, PBL, CC low, n=0, 92, 0 0
ALT, TC 2, BL, CC high, n=0, 85, 0 1
ALT, TC 2, PBL, CC high, n=0, 92, 0 5
ALP, TC 2, BL, CC high, n=0, 85, 0 0
ALP, TC 2, PBL, CC high, n=0, 92, 0 1
AST, TC 2, BL, CC high, n=0, 85, 0 1
AST, TC 2, PBL, CC high, n=0, 92, 0 2
TBIL, TC 2, BL, CC high, n=0, 85, 0 0
TBIL, TC 2, PBL, CC high, n=0, 92, 0 0
Calcium, TC 2, BL, CC low, n=0, 85, 0 0
Calcium, TC 2, PBL, CC low, n=0, 92, 0 0
Calcium, TC 2, BL, CC high, n=0, 85, 0 0
Calcium, TC 2, PBL, CC high, n=0, 92, 0 1
CO2/BCO, TC 2, BL, CC low, n=0, 85, 0 1
CO2/BCO, TC 2, PBL, CC low, n=0, 92 7
CK, TC 2, BL, CC high, n=0, 85, 0 0
CK, TC 2, PBL, CC high, n=0, 92, 0 0
Creatinine, TC 2, BL, CC high, n=0, 85, 0 0
Creatinine, TC 2,PBL, CC high, n=0, 92, 0 0
GGT, TC 2, BL, CC high, n=0, 85, 0 3
GGT, TC 2, PBL, CC high, n=0, 92, 0 3
Potassium, TC 2, BL, CC high, n=0, 85, 0 1
Potassium, TC 2, PBL, CC high, n=0, 92, 0 0
Potassium, TC 2, BL, CC low, n=0, 85, 0 0
Potassium, TC 2, PBL, CC low, n=0, 92, 0 0
Urea/BUN, TC 2, BL, CC high, n=0, 85, 0 1
Urea/BUN, TC 2, PBL, CC high, n=0, 92, 0 3
Uric acid, TC 2, BL, CC high, n=0, 85, 0 0
Uric acid, TC 2, PBL, CC high, n=0, 92, 0 1
Albumin, TC 3, BL, CC low, n=0, 57, 0 0
Albumin, TC 3, PBL, CC low, n=0, 62, 0 1
ALT, TC 3, BL, CC high, n=0, 57, 0 1
ALT, TC 3, PBL, CC high, n=0, 62, 0 1
ALP, TC 3, BL, CC high, n=0, 57, 0 0
ALP, TC 3, PBL, CC high, n=0, 62, 0 1
AST, TC 3, BL, CC high, n=0, 57, 0 1
AST, TC 3, PBL, CC high, n=0, 62, 0 0
TBIL, TC 3, BL, CC high, n=0, 57, 0 0
TBIL, TC 3, PBL, CC high, n=0, 62, 0 0
Calcium, TC 3, BL, CC low, n=0, 57, 0 0
Calcium, TC 3, PBL, CC low, n=0, 62, 0 0
Calcium, TC 3, BL, CC high, n=0, 57, 0 1
Calcium, TC 3, PBL, CC high, n=0, 62, 0 1
CO2/BCO, TC 3, BL, CC low, n=0, 57, 0 0
CO2/BCO, TC 3, PBL, CC low, n=0, 62, 0 2
CK, TC 3, BL, CC high, n=0, 57, 0 0
CK, TC 3, PBL, CC high, n=0, 62, 0 0
Creatinine, TC 3, BL, CC high, n=0, 57, 0 0
Creatinine, TC 3,PBL, CC high, n=0, 62, 0 0
GGT, TC 3, BL, CC high, n=0, 57, 0 0
GGT, TC 3, PBL, CC high, n=0, 62, 0 3
Potassium, TC 3, BL, CC high, n=0, 57, 0 0
Potassium, TC 3, PBL, CC high, n=0, 62, 0 0
Potassium, TC 3, BL, CC low, n=0, 57, 0 0
Potassium, TC 3, PBL, CC low, n=0, 62, 0 0
Urea/BUN, TC 3, BL, CC high, n=0, 57, 0 0
Urea/BUN, TC 3, PBL, CC high, n=0, 62, 0 0
Uric acid, TC 3, BL, CC high, n=0, 57, 0 0
Uric acid, TC 3, PBL, CC high, n=0, 62, 0 0
Albumin, TC 4, BL, CC low, n=0, 28, 0 0
Albumin, TC 4, PBL, CC low, n=0, 29, 0 0
ALT, TC 4, BL, CC high, n=0, 28, 0 0
ALT, TC 4, PBL, CC high, n=0, 29, 0 0
ALP, TC 4, BL, CC high, n=0, 28, 0 1
ALP, TC 4, PBL, CC high, n=0, 29, 0 1
AST, TC 4, BL, CC high, n=0, 28, 0 0
AST, TC 4, PBL, CC high, n=0, 29, 0 0
TBIL, TC 4, BL, CC high, n=0, 28, 0 0
TBIL, TC 4, PBL, CC high, n=0, 29, 0 1
Calcium, TC 4, BL, CC low, n=0, 28, 0 0
Calcium, TC 4, PBL, CC low, n=0, 29, 0 0
Calcium, TC 4, BL, CC high, n=0, 28, 0 0
Calcium, TC 4, PBL, CC high, n=0, 29, 0 0
CO2/BCO, TC 4, BL, CC low, n=0, 28, 0 1
CO2/BCO, TC 4, PBL, CC low, n=0, 29, 0 1
CK, TC 4, BL, CC high, n=0, 28, 0 0
CK, TC 4, PBL, CC high, n=0, 29, 0 0
Creatinine, TC 4, BL, CC high, n=0, 28, 0 0
Creatinine, TC 4,PBL, CC high, n=0, 29, 0 0
GGT, TC 4, BL, CC high, n=0, 28, 0 2
GGT, TC 4, PBL, CC high, n=0, 29, 0 1
Potassium, TC 4, BL, CC high, n=0, 28, 0 0
Potassium, TC 4, PBL, CC high, n=0, 29, 0 0
Potassium, TC 4, BL, CC low, n=0, 28, 0 0
Potassium, TC 4, PBL, CC low, n=0, 29, 0 0
Urea/BUN, TC 4, BL, CC high, n=0, 28, 0 0
Urea/BUN, TC 4, PBL, CC high, n=0, 29, 0 0
Uric acid, TC 4, BL, CC high, n=0, 28, 0 0
Uric acid, TC 4, PBL, CC high, n=0, 29, 0 0
Albumin, TC 5, BL, CC low, n=0, 12, 0 0
Albumin, TC 5, PBL, CC low, n=0, 13, 0 0
ALT, TC 5, BL, CC high, n=0, 12 0
ALT, TC 5, PBL, CC high, n=0, 13, 0 0
ALP, TC 5, BL, CC high, n=0, 12, 0 0
ALP, TC 5, PBL, CC high, n=0, 13, 0 0
AST, TC 5, BL, CC high, n=0, 12, 0 0
AST, TC 5, PBL, CC high, n=0, 13, 0 0
TBIL, TC 5, BL, CC high, n=0, 12, 0 0
TBIL, TC 5, PBL, CC high, n=0, 13, 0 1
Calcium, TC 5, BL, CC low, n=0, 12, 0 0
Calcium, TC 5, PBL, CC low, n=0, 13, 0 0
Calcium, TC 5, BL, CC high, n=0, 12, 0 0
Calcium, TC 5, PBL, CC high, n=0, 13, 0 0
CO2/BCO, TC 5, BL, CC low, n=0, 12, 0 0
CO2/BCO, TC 5, PBL, CC low, n=0, 13, 0 1
CK, TC 5, BL, CC high, n=0, 12, 0 0
CK, TC 5, PBL, CC high, n=0, 13, 0 0
Creatinine, TC 5, BL, CC high, n=0, 12, 0 0
Creatinine, TC 5,PBL, CC high, n=0, 13, 0 0
GGT, TC 5, BL, CC high, n=0, 12, 0 1
GGT, TC 5, PBL, CC high, n=0, 13, 0 1
Potassium, TC 5, BL, CC high, n=0, 12, 0 0
Potassium, TC 5, PBL, CC high, n=0, 13, 0 0
Potassium, TC 5, BL, CC low, n=0, 12, 0 0
Potassium, TC 5, PBL, CC low, n=0, 13, 0 0
Urea/BUN, TC 5, BL, CC high, n=0, 12, 0 0
Urea/BUN, TC 5, PBL, CC high, n=0, 13, 0 0
Uric acid, TC 5, BL, CC high, n=0, 12, 0 0
Uric acid, TC 5, PBL, CC high, n=0, 13, 0 0
Albumin, TC 6, BL, CC low, n=0, 6, 0 0
Albumin, TC 6, PBL, CC low, n=0, 6, 0 0
ALT, TC 6, BL, CC high, n=0, 6, 0 0
ALT, TC 6, PBL, CC high, n=0, 6, 0 0
ALP, TC 6, BL, CC high, n=0, 6, 0 0
ALP, TC 6, PBL, CC high, n=0, 6, 0 1
AST, TC 6, BL, CC high, n=0, 6, 0 0
AST, TC 6, PBL, CC high, n=0, 6, 0 0
TBIL, TC 6, BL, CC high, n=0, 6, 0 1
TBIL, TC 6, PBL, CC high, n=0, 6, 0 0
Calcium, TC 6, BL, CC low, n=0, 6, 0 0
Calcium, TC 6, PBL, CC low, n=0, 6, 0 0
Calcium, TC 6, BL, CC high, n=0, 6, 0 0
Calcium, TC 6, PBL, CC high, n=0, 6, 0 0
CO2/BCO, TC 6, BL, CC low, n=0, 6, 0 0
CO2/BCO, TC 6, PBL, CC low, n=0, 6, 0 0
CK, TC 6, BL, CC high, n=0, 6, 0 0
CK, TC 6, PBL, CC high, n=0, 6, 0 0
Creatinine, TC , BL, CC high, n=0, 6, 0 0
Creatinine, TC 6,PBL, CC high, n=0, 6, 0 0
GGT, TC 6, BL, CC high, n=0, 6, 0 0
GGT, TC 6, PBL, CC high, n=0, 6, 0 0
Potassium, TC 6, BL, CC high, n=0, 6, 0 0
Potassium, TC 6, PBL, CC high, n=0, 6, 0 0
Potassium, TC 6, BL, CC low, n=0, 6, 0 0
Potassium, TC 6, PBL, CC low, n=0, 6, 0 0
Urea/BUN, TC 6, BL, CC high, n=0, 6, 0 0
Urea/BUN, TC 6, PBL, CC high, n=0, 6, 0 0
Uric acid, TC 6, BL, CC high, n=0, 6, 0 0
Uric acid, TC 6, PBL, CC high, n=0, 6, 0 0
40.Secondary Outcome
Title Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 143 0
Measure Type: Number
Unit of Measure: Participants
Eosinophils, TC 1, BL,CC high, n=0, 143, 0 1
Eosinophils, TC 1,PBL,CC high, n=0, 136, 0 1
HCT, TC 1, BL, CC low, n=0, 143, 0 0
HCT, TC 1, PBL, CC low, n=0, 136, 0 1
Hb, TC 1, BL, CC low, n=0, 143, 0 1
Hb, TC 1, PBL, CC low, n=0, 136, 0 5
Monocytes, TC 1, BL, CC low, n=0, 143, 0 2
Monocytes, TC 1, PBL, CC low, n=0, 136, 0 13
Monocytes, TC 1, BL, CC high, n=0, 143, 0 0
Monocytes, TC 1, PBL, CC high, n=0, 136, 0 0
PC, TC 1, BL, CC low, n=0, 141, 0 0
PC, TC 1, PBL, CC low, n=0, 136, 0 0
PC, TC 1, BL, CC high, n=0, 141, 0 0
PC, TC 1, PBL, CC high, n=0, 136, 0 1
RBC count, TC 1, BL, CC low, n=0, 143, 0 1
RBC count, TC 1, PBL, CC low, n=0, 136, 0 2
TNUE, TC 1, BL, CC low, n=0, 142, 0 0
TNUE, TC 1, PBL, CC low, n=0, 136, 0 0
TNUE, TC 1, BL, CC high, n=0, 142, 0 0
TNUE, TC 1,PBL, CC high, n=0, 136, 0 3
WBC count, TC 1, BL, CC low, n=0, 143, 0 0
WBC count, TC 1, PBL, CC low, n=0, 136, 0 0
WBC count, TC 1, BL, CC high, n=0, 143, 0 0
WBC count, TC 1, PBL, CC high, n=0, 136, 0 1
Eosinophils, TC 2, BL,CC high, n=0, 85, 0 0
Eosinophils, TC 2,PBL,CC high, n=0, 93, 0 0
HCT, TC 2, BL, CC low, n=0, 85, 0 0
HCT, TC 2, PBL, CC low, n=0, 93, 0 0
Hb, TC 2, BL, CC low, n=0, 85, 0 1
Hb, TC 2, PBL, CC low, n=0, 93, 0 1
Monocytes, TC 2, BL, CC low, n=0, 85, 0 2
Monocytes, TC 2, PBL, CC low, n=0, 93, 0 1
Monocytes, TC 2, BL, CC high, n=0, 85, 0 0
Monocytes, TC 2, PBL, CC high, n=0, 93, 0 1
PC, TC 2, BL, CC low, n=0, 84, 0 0
PC, TC 2, PBL, CC low, n=0, 93, 0 1
PC, TC 2, BL, CC high, n=0, 84, 0 0
PC, TC 2, PBL, CC high, n=0, 93, 0 0
RBC count, TC 2, BL, CC low, n=0, 85, 0 1
RBC count, TC 2, PBL, CC low, n=0, 93, 0 1
TNUE, TC 2, BL, CC low, n=0, 85, 0 0
TNUE, TC 2, PBL, CC low, n=0, 92, 0 1
TNUE, TC 2, BL, CC high, n=0, 85, 0 1
TNUE, TC 2,PBL, CC high, n=0, 92, 0 0
WBC count, TC 2, BL, CC low, n=0, 85, 0 0
WBC count, TC 2, PBL, CC low, n=0, 93, 0 1
WBC count, TC 2, BL, CC high, n=0, 85, 0 1
WBC count, TC 2, PBL, CC high, n=0, 93, 0 0
Eosinophils, TC 3, BL,CC high, n=0, 58, 0 0
Eosinophils, TC 3,PBL,CC high, n=0, 62, 0 0
HCT, TC 3, BL, CC low, n=0, 58, 0 0
HCT, TC 3, PBL, CC low, n=0, 62, 0 0
Hb, TC 3, BL, CC low, n=0, 58, 0 0
Hb, TC 3, PBL, CC low, n=0, 62, 0 1
Monocytes, TC 3, BL, CC low, n=0, 58, 0 1
Monocytes, TC 3, PBL, CC low, n=0, 62, 0 3
Monocytes, TC 3, BL, CC high, n=0, 58, 0 0
Monocytes, TC 3, PBL, CC high, n=0, 62, 0 0
PC, TC 3, BL, CC low, n=0, 57, 0 1
PC, TC 3, PBL, CC low, n=0, 62, 0 1
PC, TC 3, BL, CC high, n=0, 57, 0 0
PC, TC 3, PBL, CC high, n=0, 62, 0 0
RBC count, TC 3, BL, CC low, n=0, 58, 0 0
RBC count, TC 3, PBL, CC low, n=0, 62, 0 0
TNUE, TC 3, BL, CC low, n=0, 57, 0 0
TNUE, TC 3, PBL, CC low, n=0, 60, 0 0
TNUE, TC 3, BL, CC high, n=0, 57, 0 0
TNUE, TC 3,PBL, CC high, n=0, 60, 0 0
WBC count, TC 3, BL, CC low, n=0, 58, 0 0
WBC count, TC 3, PBL, CC low, n=0, 62, 0 0
WBC count, TC 3, BL, CC high, n=0, 58, 0 0
WBC count, TC 4, PBL, CC high, n=0, 62, 0 0
Eosinophils, TC 4, BL,CC high, n=0, 28, 0 0
Eosinophils, TC 4,PBL,CC high, n=0, 29, 0 0
HCT, TC 4, BL, CC low, n=0, 28, 0 0
HCT, TC 4, PBL, CC low, n=0, 29, 0 0
Hb, TC 4, BL, CC low, n=0, 28, 0 1
Hb, TC 1, PBL, CC low, n=0, 29, 0 0
Monocytes, TC 4, BL, CC low, n=0, 28, 0 1
Monocytes, TC 4, PBL, CC low, n=0, 29, 0 0
Monocytes, TC 4, BL, CC high, n=0, 28, 0 0
Monocytes, TC 4, PBL, CC high, n=0, 29, 0 0
PC, TC 4, BL, CC low, n=0, 28, 0 0
PC, TC 4, PBL, CC low, n=0, 29, 0 0
PC, TC 4, BL, CC high, n=0, 28, 0 0
PC, TC 4, PBL, CC high, n=0, 29, 0 0
RBC count, TC 4, BL, CC low, n=0, 28, 0 1
RBC count, TC 4, PBL, CC low, n=0, 29, 0 0
TNUE, TC 4, BL, CC low, n=0, 26, 0 0
TNUE, TC 4, PBL, CC low, n=0, 28, 0 0
TNUE, TC 4, BL, CC high, n=0, 26, 0 0
TNUE, TC 4,PBL, CC high, n=0, 28, 0 0
WBC count, TC 4, BL, CC low, n=0, 28, 0 0
WBC count, TC 4, PBL, CC low, n=0, 29, 0 0
WBC count, TC 4, BL, CC high, n=0, 28, 0 0
WBC count, TC 4, PBL, CC high, n=0, 29, 0 0
Eosinophils, TC 5, BL,CC high, n=0, 12, 0 0
Eosinophils, TC 5,PBL,CC high, n=0, 13, 0 0
HCT, TC 5, BL, CC low, n=0, 12, 0 0
HCT, TC 5, PBL, CC low, n=0, 13, 0 0
Hb, TC 5, BL, CC low, n=0, 12 0
Hb, TC 5, PBL, CC low, n=0, 13, 0 0
Monocytes, TC 5, BL, CC low, n=0, 12, 0 0
Monocytes, TC 5, PBL, CC low, n=0, 13, 0 0
Monocytes, TC 5, BL, CC high, n=0, 12, 0 0
Monocytes, TC 5, PBL, CC high, n=0, 13, 0 0
PC, TC 5, BL, CC low, n=0, 12, 0 0
PC, TC 5, PBL, CC low, n=0, 13, 0 0
PC, TC 5, BL, CC high, n=0, 12, 0 0
PC, TC 5, PBL, CC high, n=0, 13, 0 0
RBC count, TC 5, BL, CC low, n=0, 12, 0 0
RBC count, TC 5, PBL, CC low, n=0, 13, 0 0
TNUE, TC 5, BL, CC low, n=0, 11, 0 0
TNUE, TC 5, PBL, CC low, n=0, 13 0
TNUE, TC 5, BL, CC high, n=0, 11 0
TNUE, TC 5,PBL, CC high, n=0, 13, 0 0
WBC count, TC 5, BL, CC low, n=0, 12, 0 0
WBC count, TC 5, PBL, CC low, n=0, 13, 0 0
WBC count, TC 5, BL, CC high, n=0, 12, 0 0
WBC count, TC 5, PBL, CC high, n=0, 13, 0 0
Eosinophils, TC 6, BL,CC high, n=0, 6, 0 0
Eosinophils, TC 6,PBL,CC high, n=0, 6, 0 0
HCT, TC 6, BL, CC low, n=0, 6, 0 0
HCT, TC 6, PBL, CC low, n=0, 6, 0 0
Hb, TC 6, BL, CC low, n=0, 6, 0 0
Hb, TC 6, PBL, CC low, n=0, 6, 0 0
Monocytes, TC 6, BL, CC low, n=0, 6, 0 0
Monocytes, TC 6, PBL, CC low, n=0, 6, 0 0
Monocytes, TC 6, BL, CC high, n=0, 6, 0 0
Monocytes, TC 6, PBL, CC high, n=0, 6, 0 0
PC, TC 6, BL, CC low, n=0, 6, 0 0
PC, TC 6, PBL, CC low, n=0, 6, 0 0
PC, TC 6, BL, CC high, n=0, 6, 0 0
PC, TC 6, PBL, CC high, n=0, 6, 0 0
RBC count, TC 6, BL, CC low, n=0, 6, 0 0
RBC count, TC 6, PBL, CC low, n=0, 6, 0 0
TNUE, TC 6, BL, CC low, n=0, 6, 0 0
TNUE, TC 6, PBL, CC low, n=0, 6, 0 0
TNUE, TC 6, BL, CC high, n=0, 6, 0 0
TNUE, TC 6,PBL, CC high, n=0, 6, 0 0
WBC count, TC 6, BL, CC low, n=0, 6, 0 0
WBC count, TC 6, PBL, CC low, n=0, 6, 0 0
WBC count, TC 6, BL, CC high, n=0, 6, 0 0
WBC count, TC 6, PBL, CC high, n=0, 6, 0 0
41.Secondary Outcome
Title Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 148 0
Measure Type: Number
Unit of Measure: Participants
DBP, TC 1, BL, <LLN, n=0, 148, 0 0
DBP, TC 1, PBL, <LLN, n=0, 148, 0 2
DBP, TC 1, BL, >ULN, n=0, 148, 0 0
DBP, TC 1, PBL, >ULN, n=0, 148, 0 1
SBP, TC 1, BL, <LLN, n=0, 148, 0 0
SBP, TC 1, PBL, <LLN, n=0, 148, 0 7
SBP, TC 1, BL, >ULN, n=0, 148, 0 0
SBP, TC 1, PBL, >ULN, n=0, 148, 0 7
HR, TC 1, BL, <LLN, n=0, 148, 0 0
HR, TC 1, PBL, <LLN, n=0, 148, 0 0
HR, TC 1, BL, >ULN, n=0, 148, 0 0
HR, TC 1, PBL, >ULN, n=0, 148, 0 1
DBP, TC 2, BL, <LLN, n=0, 93, 0 0
DBP, TC 2, PBL, <LLN, n=0, 93, 0 0
DBP, TC 2, BL, >ULN, n=0, 93, 0 0
DBP, TC 2, PBL, >ULN, n=0, 93, 0 0
SBP, TC 2, BL, <LLN, n=0, 93, 0 0
SBP, TC 2, PBL, <LLN, n=0, 93, 0 3
SBP, TC 2, BL, >ULN, n=0, 93, 0 0
SBP, TC 2, PBL, >ULN, n=0, 93, 0 6
HR, TC 2, BL, <LLN, n=0, 93, 0 0
HR, TC 2, PBL, <LLN, n=0, 93, 0 0
HR, TC 2, BL, >ULN, n=0, 93, 0 0
HR, TC 2, PBL, >ULN, n=0, 93, 0 1
DBP, TC 3, BL, <LLN, n=0, 62, 0 0
DBP, TC 3, PBL, <LLN, n=0, 63, 0 0
DBP, TC 3, BL, >ULN, n=0, 62, 0 0
DBP, TC 3, PBL, >ULN, n=0, 63, 0 0
SBP, TC 3, BL, <LLN, n=0, 62, 0 0
SBP, TC 3, PBL, <LLN, n=0, 63, 0 0
SBP, TC 3, BL, >ULN, n=0, 62, 0 0
SBP, TC 3, PBL, >ULN, n=0, 63, 0 0
HR, TC 3, BL, <LLN, n=0, 62, 0 0
HR, TC 3, PBL, <LLN, n=0, 63, 0 0
HR, TC 3, BL, >ULN, n=0, 62, 0 0
HR, TC 3, PBL, >ULN, n=0, 63, 0 0
DBP, TC 4, BL, <LLN, n=0, 29, 0 0
DBP, TC 4, PBL, <LLN, n=0, 30, 0 0
DBP, TC 4, BL, >ULN, n=0, 29, 0 0
DBP, TC 4, PBL, >ULN, n=0, 30, 0 0
SBP, TC 4, BL, <LLN, n=0, 29, 0 0
SBP, TC 4, PBL, <LLN, n=0, 30, 0 2
SBP, TC 4, BL, >ULN, n=0, 29, 0 0
SBP, TC 4, PBL, >ULN, n=0, 30, 0 1
HR, TC 4, BL, <LLN, n=0, 29, 0 0
HR, TC 4, PBL, <LLN, n=0, 30, 0 0
HR, TC 4, BL, >ULN, n=0, 29, 0 0
HR, TC 4, PBL, >ULN, n=0, 30, 0 0
DBP, TC 5, BL, <LLN, n=0, 13, 0 0
DBP, TC 5, PBL, <LLN, n=0, 13, 0 0
DBP, TC 5, BL, >ULN, n=0, 13, 0 0
DBP, TC 5, PBL, >ULN, n=0, 13, 0 0
SBP, TC 5, BL, <LLN, n=0, 13, 0 0
SBP, TC 5, PBL, <LLN, n=0, 13, 0 2
SBP, TC 5, BL, >ULN, n=0, 13, 0 0
SBP, TC 5, PBL, >ULN, n=0, 13, 0 0
HR, TC 5, BL, <LLN, n=0, 13, 0 0
HR, TC 5, PBL, <LLN, n=0, 13, 0 0
HR, TC 5, BL, >ULN, n=0, 13, 0 0
HR, TC 5, PBL, >ULN, n=0, 13, 0 0
DBP, TC 6, BL, <LLN, n=0, 6, 0 0
DBP, TC 6, PBL, <LLN, n=0, 6, 0 0
DBP, TC 6, BL, >ULN, n=0, 6, 0 0
DBP, TC 6, PBL, >ULN, n=0, 6, 0 0
SBP, TC 6, BL, <LLN, n=0, 6, 0 0
SBP, TC 6, PBL, <LLN, n=0, 6, 0 1
SBP, TC 6, BL, >ULN, n=0, 6, 0 0
SBP, TC 6, PBL, >ULN, n=0, 6, 0 0
HR, TC 6, BL, <LLN, n=0, 6, 0 0
HR, TC 6, PBL, <LLN, n=0, 6, 0 0
HR, TC 6, BL, >ULN, n=0, 6, 0 0
HR, TC 6, PBL, >ULN, n=0, 6, 0 0
42.Secondary Outcome
Title Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course
Hide Description The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.
Time Frame From baseline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 141 0
Measure Type: Number
Unit of Measure: Participants
IgA, TC 1, BL, <LLN, n=0, 141, 0 1
IgA, TC 1, PBL, <LLN, n=0, 133, 0 1
IgA, TC 1, BL, >ULN, n=0, 141, 0 16
IgA, TC 1, PBL, >ULN, n=0, 133, 0 14
IgG, TC 1, BL, <LLN, n=0, 141, 0 0
IgG, TC 1, PBL, <LLN, n=0, 133, 0 4
IgG, TC 1, BL, >ULN, n=0, 141, 0 43
IgG, TC 1, PBL, >ULN, n=0, 133, 0 25
IgM, TC 1, BL, <LLN, n=0, 141, 0 7
IgM, TC 1, PBL, <LLN, n=0, 133, 0 18
IgM, TC 1, BL, >ULN, n=0, 141, 0 19
IgM, TC 1, PBL, >ULN, n=0, 133, 0 12
IgA, TC 2, BL, <LLN, n=0, 85, 0 0
IgA, TC 2, PBL, <LLN, n=0, 93, 0 0
IgA, TC 2, BL, >ULN, n=0, 85, 0 9
IgA, TC 2, PBL, >ULN, n=0, 93, 0 1
IgG, TC 2, BL, <LLN, n=0, 85, 0 1
IgG, TC 2, PBL, <LLN, n=0, 93, 0 3
IgG, TC 2, BL, >ULN, n=0, 85, 0 11
IgG, TC 2, PBL, >ULN, n=0, 93, 0 12
IgM, TC 2, BL, <LLN, n=0, 85, 0 10
IgM, TC 2, PBL, <LLN, n=0, 93, 0 18
IgM, TC 2, BL, >ULN, n=0, 85, 0 6
IgM, TC 2, PBL, >ULN, n=0, 93, 0 5
IgA, TC 3, BL, <LLN, n=0, 59, 0 0
IgA, TC 3, PBL, <LLN, n=0, 62, 0 0
IgA, TC 3, BL, >ULN, n=0, 59, 0 5
IgA, TC 3, PBL, >ULN, n=0, 62, 0 5
IgG, TC 3, BL, <LLN, n=0, 59, 0 0
IgG, TC 3, PBL, <LLN, n=0, 62, 0 2
IgG, TC 3, BL, >ULN, n=0, 59, 0 6
IgG, TC 3, PBL, >ULN, n=0, 62, 0 5
IgM, TC 3, BL, <LLN, n=0, 59, 0 7
IgM, TC 3, PBL, <LLN, n=0, 62, 0 11
IgM, TC 3, BL, >ULN, n=0, 59, 0 3
IgM, TC 3, PBL, >ULN, n=0, 62, 0 2
IgA, TC 4, BL, <LLN, n=0, 28, 0 0
IgA, TC 4, PBL, <LLN, n=0, 29, 0 0
IgA, TC 4, BL, >ULN, n=0, 28, 0 4
IgA, TC 4, PBL, >ULN, n=0, 29, 0 5
IgG, TC 4, BL, <LLN, n=0, 28, 0 0
IgG, TC 4, PBL, <LLN, n=0, 29, 0 1
IgG, TC 4, BL, >ULN, n=0, 28, 0 1
IgG, TC 4, PBL, >ULN, n=0, 29, 0 1
IgM, TC 4, BL, <LLN, n=0, 28, 0 1
IgM, TC 4, PBL, <LLN, n=0, 29, 0 2
IgM, TC 4, BL, >ULN, n=0, 28, 0 1
IgM, TC 4, PBL, >ULN, n=0, 29, 0 1
IgA, TC 5, BL, <LLN, n=0, 12, 0 0
IgA, TC 5, PBL, <LLN, n=0, 13, 0 0
IgA, TC 5, BL, >ULN, n=0, 12, 0 2
IgA, TC 5, PBL, >ULN, n=0, 13, 0 2
IgG, TC 5, BL, <LLN, n=0, 12, 0 1
IgG, TC 5, PBL, <LLN, n=0, 13, 0 1
IgG, TC 5, BL, >ULN, n=0, 12, 0 0
IgG, TC 5, PBL, >ULN, n=0, 13, 0 1
IgM, TC 5, BL, <LLN, n=0, 12, 0 0
IgM, TC 5, PBL, <LLN, n=0, 13, 0 0
IgM, TC 5, BL, >ULN, n=0, 12, 0 1
IgM, TC 5, PBL, >ULN, n=0, 13, 0 1
IgA, TC 6, BL, <LLN, n=0, 6, 0 0
IgA, TC 6, PBL, <LLN, n=0, 6, 0 0
IgA, TC 6, BL, >ULN, n=0, 6, 0 0
IgA, TC 6, PBL, >ULN, n=0, 6, 0 0
IgG, TC 6, BL, <LLN, n=0, 6, 0 0
IgG, TC 6, PBL, <LLN, n=0, 6, 0 0
IgG, TC 6, BL, >ULN, n=0, 6, 0 0
IgG, TC 6, PBL, >ULN, n=0, 6, 0 0
IgM, TC 6, BL, <LLN, n=0, 6, 0 0
IgM, TC 6, PBL, <LLN, n=0, 6, 0 0
IgM, TC 6, BL, >ULN, n=0, 6, 0 0
IgM, TC 6, PBL, >ULN, n=0, 6, 0 0
43.Secondary Outcome
Title Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods
Hide Description Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.
Time Frame From basline up to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 118 0
Measure Type: Number
Unit of Measure: Participants
TC 1, BL, n=0, 76, 0 1
TC 1, PBL, n=0, 118, 0 1
TC 2, BL, n=0, 45, 0 0
TC 2, PBL, n=0, 81, 0 1
TC 3, BL, n=0, 30, 0 1
TC 3, PBL, n=0, 48, 0 0
TC 4, BL, n=0, 10, 0 0
TC 4, PBL, n=0, 25, 0 0
TC 5, BL, n=0, 4, 0 0
TC 5, PBL, n=0, 8, 0 0
TC 6, BL, n=0, 3, 0 0
TC 6, PBL, n=0, 6, 0 0
44.Secondary Outcome
Title Number of Participants With Any Serious Adverse Event During the Follow-up Period
Hide Description A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.
Time Frame From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 132
Measure Type: Number
Unit of Measure: Participants
17
45.Secondary Outcome
Title Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period
Hide Description The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.
Time Frame From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 123
Measure Type: Number
Unit of Measure: Participants
IgA <LLN 0
IgA >ULN 15
IgG <LLN 7
IgG >ULN 18
IgM <LLN 23
IgM >ULN 4
46.Secondary Outcome
Title Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab
Hide Description Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.
Time Frame From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 63
Median (Full Range)
Unit of Measure: Months
Relative to first dose, n=0, 0, 63
22.013
(0.46 to 49.25)
Relative to last dose, n=0, 0, 60
12.567
(0.03 to 29.47)
47.Secondary Outcome
Title Number of Participants With a Positive JC Virus Test Result During the Follow-up Period
Hide Description Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.
Time Frame From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only those participants contributing values at the indicated time point were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 132
Measure Type: Number
Unit of Measure: Participants
7
48.Secondary Outcome
Title Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period
Hide Description Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.
Time Frame From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 132
Measure Type: Number
Unit of Measure: Participants
ALT 1
ALP 1
CK 2
CO2/BCO 2
GGT 1
TBIL 1
Urea/BUN 1
49.Secondary Outcome
Title Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period
Hide Description Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.
Time Frame From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg Placebo or OFA 700 mg: FU Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 132
Measure Type: Number
Unit of Measure: Participants
Eosinophils 1
Total neutrophils 2
Platelet count 1
Time Frame Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period.
Adverse Event Reporting Description SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
 
Arm/Group Title Placebo: DB Period Ofatumumab 700 mg: DB and OL Periods Placebo or Ofatumumab 700 mg: Follow-up Period
Hide Arm/Group Description Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course). SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
All-Cause Mortality
Placebo: DB Period Ofatumumab 700 mg: DB and OL Periods Placebo or Ofatumumab 700 mg: Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo: DB Period Ofatumumab 700 mg: DB and OL Periods Placebo or Ofatumumab 700 mg: Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/83 (7.23%)   30/148 (20.27%)   17/132 (12.88%) 
Blood and lymphatic system disorders       
Pancytopenia  1  0/83 (0.00%)  0/148 (0.00%)  1/132 (0.76%) 
Cardiac disorders       
Myocardial infarction  1  0/83 (0.00%)  1/148 (0.68%)  0/132 (0.00%) 
Eye disorders       
Retinal detachment  1  0/83 (0.00%)  1/148 (0.68%)  0/132 (0.00%) 
Cataract  1  0/83 (0.00%)  2/148 (1.35%)  0/132 (0.00%) 
Gastrointestinal disorders       
Gastritis  1  0/83 (0.00%)  0/148 (0.00%)  0/132 (0.00%) 
General disorders       
Implant site reaction  1  0/83 (0.00%)  1/148 (0.68%)  0/132 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/83 (0.00%)  1/148 (0.68%)  0/132 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  0/83 (0.00%)  4/148 (2.70%)  0/132 (0.00%) 
Hypersensitivity  1  0/83 (0.00%)  2/148 (1.35%)  0/132 (0.00%) 
Anaphylactic shock  1  0/83 (0.00%)  1/148 (0.68%)  0/132 (0.00%) 
Infections and infestations       
Meningitis viral  1  1/83 (1.20%)  0/148 (0.00%)  0/132 (0.00%) 
Urinary tract infection  1  0/83 (0.00%)  2/148 (1.35%)