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

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ClinicalTrials.gov Identifier: NCT00611455
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 : February 11, 2008
Results First Posted : October 28, 2011
Last Update Posted : November 6, 2017
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 265
Recruitment Details  
Pre-assignment Details Study OFA110635 was comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who completed the OL Period, or who were withdrawn, entered a Follow-up (FU) period (approximately 2 years).
Arm/Group Title Placebo Ofatumumab 700 mg 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who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a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 134 131 0
Completed 121 117 0
Not Completed 13 14 0
Reason Not Completed
Adverse Event             2             8             0
Lack of Efficacy             2             0             0
Protocol Violation             4             1             0
Withdrawal by Subject             2             3             0
Randomized in Error; Not Treated             2             2             0
Randomized, but Not Treated             1             0             0
Period Title: OL Treatment Period (120 Weeks)
Started 0 231 [1] 0
Completed 0 52 0
Not Completed 0 179 0
Reason Not Completed
Adverse Event             0             17             0
Lack of Efficacy             0             9             0
Protocol Violation             0             3             0
Protocol-defined Stopping Criteria Met             0             12             0
Study Closed/Terminated             0             110             0
Lost to Follow-up             0             5             0
Physician Decision             0             5             0
Withdrawal by Subject             0             18             0
[1]
118 participants received OFA during the DB Period; 113 received placebo during the DB Period.
Period Title: Follow-up Period (Approximately 2 Years)
Started 0 0 260 [1]
Completed 0 0 49
Not Completed 0 0 211
Reason Not Completed
Adverse Event             0             0             30
Lack of Efficacy             0             0             12
Protocol Violation             0             0             4
Protocol-defined Stopping Criteria Met             0             0             23
Study Closed/Terminated             0             0             80
Lost to Follow-up             0             0             13
Withdrawal by Subject             0             0             49
[1]
These participants received at least one infusion of placebo or ofatumumab.
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 131 129 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 129 participants 260 participants
53.6  (11.50) 51.7  (11.24) 52.7  (11.39)
[1]
Measure Description: Baseline characteristics are reported for members of the Intent-to-Treat (ITT) Population, comprised of 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.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 129 participants 260 participants
Female
108
  82.4%
106
  82.2%
214
  82.3%
Male
23
  17.6%
23
  17.8%
46
  17.7%
[1]
Measure Description: Baseline characteristics are reported for members of the ITT Population, comprised of 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.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 129 participants 260 participants
Hispanic/Latino 52 51 103
Not Hispanic/Latino 79 78 157
[1]
Measure Description: Baseline characteristics are reported for members of the ITT Population, comprised of 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.
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 131 129
Measure Type: Number
Unit of Measure: participants
35 64
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ofatumumab 700 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
1.67 to 4.91
Estimation Comments [Not Specified]
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 131 129
Measure Type: Number
Unit of Measure: participants
Week 4 42 52
Week 8 43 66
Week 12 44 71
Week 16 38 67
Week 20 40 62
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 131 129
Measure Type: Number
Unit of Measure: participants
Week 4 13 14
Week 8 12 23
Week 12 14 36
Week 16 13 37
Week 20 19 31
Week 24 14 35
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 131 129
Measure Type: Number
Unit of Measure: participants
Week 4 6 4
Week 8 3 10
Week 12 6 19
Week 16 5 18
Week 20 6 18
Week 24 3 17
5.Secondary Outcome
Title Median 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 percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 130 126
Median (Full Range)
Unit of Measure: percent change
Week 4, n=129, 124
6.0
(-77 to 85)
13.0
(-98 to 92)
Week 8, n=130, 126
5.5
(-250 to 86)
22.0
(-264 to 84)
Week 12, n=130, 126
0.5
(-200 to 85)
25.0
(-73 to 100)
Week 16, n=130, 126
0.0
(-210 to 85)
26.0
(-138 to 93)
Week 20, n=130, 126
4.0
(-185 to 90)
21.0
(-74 to 92)
Week 24, n=130, 126
-2.5
(-272 to 90)
21.0
(-87 to 95)
6.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=129, 124 4.78  (1.241) 4.74  (1.099)
Week 8, n=130, 126 4.75  (1.205) 4.41  (1.285)
Week 12, n=130, 126 4.66  (1.333) 4.14  (1.367)
Week 16, n=130, 126 4.78  (1.327) 4.11  (1.296)
Week 20, n=130, 126 4.78  (1.387) 4.13  (1.395)
Week 24, n=130, 126 4.98  (1.437) 4.12  (1.270)
7.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 RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 130 126
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=129, 124 -0.84  (1.053) -1.09  (0.886)
Week 8, n=130, 126 -0.88  (0.992) -1.41  (1.112)
Week 12, n=130, 126 -0.97  (1.221) -1.69  (1.255)
Week 16, n=130, 126 -0.85  (1.194) -1.72  (1.166)
Week 20, n=130, 126 -0.85  (1.215) -1.70  (1.262)
Week 24, n=130, 126 -0.65  (1.218) -1.71  (1.201)
8.Secondary Outcome
Title Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (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 (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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=129, 124 5.48  (1.332) 5.51  (1.127)
Week 8, n=130, 126 5.43  (1.289) 5.14  (1.276)
Week 12, n=130, 126 5.31  (1.349) 4.83  (1.358)
Week 16, n=130, 126 5.43  (1.329) 4.81  (1.310)
Week 20, n=130, 126 5.41  (1.414) 4.77  (1.427)
Week 24, n=130, 126 5.67  (1.439) 4.84  (1.360)
9.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 RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 130 126
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4, n=129, 124 -0.92  (1.106) -1.08  (0.891)
Week 8, n=130, 126 -0.97  (1.048) -1.46  (1.092)
Week 12, n=130, 126 -1.10  (1.211) -1.77  (1.257)
Week 16, n=130, 126 -0.97  (1.183) -1.79  (1.189)
Week 20, n=130, 126 -0.99  (1.175) -1.83  (1.304)
Week 24, n=130, 126 -0.73  (1.203) -1.76  (1.264)
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 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 Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 130 126
Measure Type: Number
Unit of Measure: participants
Week 4, Good; n=129, 124 15 12
Week 4, Moderate; n=129, 124 41 63
Week 4, None; n=129, 124 73 49
Week 8, Good; n=130, 126 16 22
Week 8, Moderate; n=130, 126 49 62
Week 8, None; n=130, 126 65 42
Week 12, Good; n=130, 126 17 32
Week 12, Moderate; n=130, 126 51 56
Week 12, None; n=130, 126 62 38
Week 16, Good; n=130, 126 16 32
Week 16, Moderate; n=130, 126 51 58
Week 16, None; n=130, 126 63 36
Week 20, Good; n=130, 126 17 34
Week 20, Moderate; n=130, 126 41 52
Week 20, None; n=130, 126 72 40
Week 24, Good; n=130, 126 18 32
Week 24, Moderate; n=130, 126 37 60
Week 24, None; n=130, 126 75 34
11.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 Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 130 126
Measure Type: Number
Unit of Measure: participants
Week 4, Good; n=129, 124 6 5
Week 4, Moderate; n=129, 124 49 50
Week 4, None; n=129, 124 74 69
Week 8, Good; n=130, 126 7 8
Week 8, Moderate; n=130, 126 53 67
Week 8, None; n=130, 126 70 51
Week 12, Good; n=130, 126 7 17
Week 12, Moderate; n=130, 126 57 63
Week 12, None; n=130, 126 66 46
Week 16, Good; n=130, 126 4 15
Week 16, Moderate; n=130, 126 58 70
Week 16, None; n=130, 126 68 41
Week 20, Good; n=130, 126 8 22
Week 20, Moderate; n=130, 126 45 63
Week 20, None; n=130, 126 77 41
Week 24, Good; n=130, 126 4 14
Week 24, Moderate; n=130, 126 44 67
Week 24, None; n=130, 126 82 45
12.Secondary Outcome
Title Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)
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 Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 117 112
Measure Type: Number
Unit of Measure: participants
59 74
13.Secondary Outcome
Title Number of Participants With Clinical Remission at Week 24
Hide Description Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) <2.6 at Week 24.
Time Frame Week 24
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 131 129
Measure Type: Number
Unit of Measure: participants
7 13
14.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Median (Full Range)
Unit of Measure: number of tender joints
-5
(-38 to 36)
-12
(-52 to 20)
15.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Median (Full Range)
Unit of Measure: number of swollen joints
-4.50
(-24 to 16)
-8.00
(-43 to 12)
16.Secondary Outcome
Title Change From Baseline in the Participant-assessed Pain Score 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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 128 119
Median (Full Range)
Unit of Measure: scores on a scale
-5
(-93 to 54)
-22
(-95 to 35)
17.Secondary Outcome
Title Change From Baseline in Participant-assessed Global Disease Score 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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Median (Full Range)
Unit of Measure: scores on a scale
-6.0
(-76 to 57)
-16.5
(-83 to 28)
18.Secondary Outcome
Title Change From Baseline in the Physician-assessed Global Disease Score 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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 124
Median (Full Range)
Unit of Measure: scores on a scale
-9.50
(-70 to 37)
-20.50
(-77 to 17)
19.Secondary Outcome
Title Change From Baseline in HAQ-DI Score at Week 24
Hide Description The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 123 122
Median (Full Range)
Unit of Measure: scores on a scale
-0.25
(-2.4 to 1.3)
-0.38
(-2.4 to 1.0)
20.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Median (Full Range)
Unit of Measure: milligrams per liter (mg/L)
-0.10
(-55.1 to 96.2)
-4.85
(-96.2 to 30.2)
21.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 130 126
Median (Full Range)
Unit of Measure: millimeters per hour (mm/hr)
-5
(-57 to 89)
-15
(-85 to 34)
22.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 117 116
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Physical Component Summary 4.21  (1.048) 6.69  (1.031)
Physical Functioning 3.14  (1.125) 5.70  (1.100)
Role Physical 5.43  (1.259) 6.64  (1.231)
Bodily Pain 3.63  (1.197) 8.28  (1.170)
General Health 2.28  (1.033) 4.08  (1.011)
23.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 117 116
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Mental Component Summary 1.57  (1.308) 4.60  (1.272)
Vitality 2.46  (1.169) 7.26  (1.154)
Social Functioning 3.56  (1.361) 4.98  (1.331)
Role Emotional 2.23  (1.612) 4.93  (1.563)
Mental Health 2.92  (1.278) 5.40  (1.249)
24.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. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
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 111 114
Median (Full Range)
Unit of Measure: scores on a scale
2
(-37 to 27)
6
(-19 to 42)
25.Secondary Outcome
Title Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24
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 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 120 115
Median (Full Range)
Unit of Measure: Units/Liter
Anti-CCP, n=120, 115
0.0
(-1613 to 4042)
-138.0
(-13000 to 762)
RF-IgA, n=119, 110
0.0
(-79 to 72)
-3
(-93 to 3)
RF-IgG, n=119, 110
0.0
(-71 to 58)
-4.8
(-87 to 9)
RF-IgM, n=119, 110
0.0
(-68 to 98)
-6.3
(-93 to 98)
26.Secondary Outcome
Title Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24
Hide Description The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.
Arm/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 120 115
Median (Full Range)
Unit of Measure: nanogram per liter (ng/l)
IL-6, n=119, 115
-0.410
(-131.26 to 2632.66)
-4.040
(-106.98 to 63.44)
Serum Amyloid A, n=120, 114
-10850.5
(-1680680 to 3374580)
-53513.5
(-3724434 to 931790)
27.Secondary Outcome
Title Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (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. 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:
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.
Overall Number of Participants Analyzed 0 243 0
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
TC 1, n=0, 243, 0 4.01  (1.396)
TC 2, n=0, 198, 0 3.59  (1.227)
TC 3, n=0, 136, 0 3.36  (1.225)
TC 4, n=0, 72, 0 3.50  (1.175)
TC 5, n=0, 31, 0 3.34  (1.326)
TC 6, n=0, 11, 0 3.82  (1.588)
TC 7, n=0, 2, 0 5.34  (1.038)
28.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. 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:
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.
Overall Number of Participants Analyzed 0 243 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 243, 0 3.43  (1.321)
TC 2, n=0, 198, 0 3.09  (1.142)
TC 3, n=0, 136, 0 2.86  (1.156)
TC 4, n=0, 72, 0 2.94  (1.161)
TC 5, n=0, 31, 0 2.90  (1.362)
TC 6, n=0, 11, 0 3.39  (1.401)
TC 7, n=0, 2, 0 4.55  (1.003)
29.Secondary Outcome
Title Minimum Change From Baseline in the 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:
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.
Overall Number of Participants Analyzed 0 238 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 238, 0 -2.32  (1.192)
TC 2, n=0, 194, 0 -1.77  (1.072)
TC 3, n=0, 129, 0 -1.77  (1.203)
TC 4, n=0, 69, 0 -1.47  (1.065)
TC 5, n=0, 31, 0 -1.77  (1.015)
TC 6, n=0, 11, 0 -1.45  (0.845)
TC 7, n=0, 2, 0 -0.07  (0.696)
30.Secondary Outcome
Title Minimum Change From Baseline in the 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:
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.
Overall Number of Participants Analyzed 0 237 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
TC 1, n=0, 237, 0 -2.15  (1.166)
TC 2, n=0, 193, 0 -1.55  (1.020)
TC 3, n=0, 125, 0 -1.67  (1.144)
TC 4, n=0, 69, 0 -1.40  (1.081)
TC 5, n=0, 31, 0 -1.61  (1.036)
TC 6, n=0, 11, 0 -1.33  (0.710)
TC 7, n=0, 2, 0 -0.05  (0.200)
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:
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.
Overall Number of Participants Analyzed 0 243 0
Measure Type: Number
Unit of Measure: participants
TC 1, Remission, n=0, 243, 0 38
TC 1, Low Disease Activity, n=0, 243, 0 33
TC 2, Remission, n=0, 198, 0 47
TC 2, Low Disease Activity, n=0, 198, 0 33
TC 3, Remission, n=0, 136, 0 40
TC 3, Low Disease Activity, n=0, 136, 0 31
TC 4, Remission, n=0, 72, 0 15
TC 4, Low Disease Activity, n=0, 72, 0 20
TC 5, Remission, n=0, 31, 0 13
TC 5, Low Disease Activity, n=0, 31, 0 4
TC 6, Remission, n=0, 11, 0 3
TC 6, Low Disease Activity, n=0, 11, 0 1
TC 7, Remission, n=0, 2, 0 0
TC 7, Low Disease Activity, n=0, 2, 0 0
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:
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.
Overall Number of Participants Analyzed 0 243 0
Measure Type: Number
Unit of Measure: participants
TC 1, Remission, n=0, 243, 0 71
TC 1, Low Disease Activity, n=0, 243, 0 44
TC 2, Remission, n=0, 198, 0 71
TC 2, Low Disease Activity, n=0, 198, 0 36
TC 3, Remission, n=0, 136, 0 63
TC 3, Low Disease Activity, n=0, 136, 0 21
TC 4, Remission, n=0, 72, 0 30
TC 4, Low Disease Activity, n=0, 72, 0 11
TC 5, Remission,n=0, 31, 0 14
TC 5, Low Disease Activity,n=0, 31, 0 4
TC 6, Remission,n=0, 11, 0 4
TC 6, Low Disease Activity,n=0, 11, 0 2
TC 7, Remission, n=0, 2, 0 0
TC 7, Low Disease Activity, n=0, 2, 0 0
33.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 who were retreated from Week 24 were analyzed.
Arm/Group Title Placebo Ofatumumab 700 mg 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.
Overall Number of Participants Analyzed 0 198 0
Mean (Standard Deviation)
Unit of Measure: Weeks
TC 1, n=0, 198, 0 34.26  (15.828)
TC 2, n=0, 136, 0 34.50  (15.151)
TC 3, n=0, 72, 0 28.83  (10.713)
TC 4, n=0, 31, 0 20.82  (6.952)
TC 5, n=0, 11, 0 19.94  (5.411)
TC 6, n=0, 2, 0 17.86  (0.404)
TC 7, n=0, 0, 0 NA [1]   (NA)
[1]
Data are not available because there was no subsequent treatment course after Treatment Course 7.
34.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:
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.
Overall Number of Participants Analyzed 0 243 0
Measure Type: Number
Unit of Measure: Participants
Any AE, TC 1, n=0, 243, 0 212
Any AE, TC 2, n=0, 198, 0 151
Any AE, TC 3, n=0, 136, 0 91
Any AE, TC 4, n=0, 72, 0 43
Any AE, TC 5, n=0, 31, 0 14
Any AE, TC 6, n=0, 11, 0 5
Any AE, TC 7, n=0, 2, 0 0
Any SAE, TC 1, n=0, 243, 0 14
Any SAE, TC 2, n=0, 198, 0 19
Any SAE, TC 3, n=0, 136, 0 12
Any SAE, TC 4, n=0, 72, 0 4
Any SAE, TC 5, n=0, 31, 0 1
Any SAE, TC 6, n=0, 11, 0 0
Any SAE, TC 7, n=0, 2, 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 the Indicated 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:
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.
Overall Number of Participants Analyzed 0 237 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 237, 0 1
TC 1, Week 16, n=0, 182, 0 1
TC 1, Week 24, n=0, 177, 0 2
TC 1, Week 32, n=0, 96, 0 9
TC 1, Week 40, n=0, 59, 0 3
TC 1, Week 48, n=0, 46, 0 9
TC 1, Week 56, n=0, 31, 0 5
TC 1, Week 64, n=0, 23, 0 7
TC 1, Week 72, n=0, 19, 0 4
TC 1, Week 80, n=0, 15, 0 5
TC 1, Week 88, n=0, 13, 0 1
TC 1, Week 96, n=0, 12, 0 4
TC 1, Week 104, n=0, 10, 0 1
TC 1, Week 112, n=0, 8, 0 0
TC 1, Week 120, n=0, 7, 0 1
TC 1, Week 128, n=0, 4, 0 2
TC 1, Week 136, n=0, 4, 0 1
TC 1, Week 144, n=0, 4, 0 1
TC 2, Week 8, n=0, 194, 0 1
TC 2, Week 16, n=0, 177, 0 1
TC 2, Week 24, n=0, 150, 0 1
TC 2, Week 32, n=0, 97, 0 7
TC 2, Week 40, n=0, 69, 0 12
TC 2, Week 48, n=0, 58, 0 8
TC 2, Week 56, n=0, 43, 0 13
TC 2, Week 64, n=0, 31, 0 13
TC 2, Week 72, n=0, 24, 0 11
TC 2, Week 80, n=0, 21, 0 12
TC 2, Week 88, n=0, 16, 0 7
TC 2, Week 96, n=0, 10, 0 6
TC 2, Week 104, n=0, 8, 0 5
TC 2, Week 112, n=0, 4, 0 2
TC 2, Week 120, n=0, 3, 0 2
TC 2, Week 128, n=0, 1, 0 0
TC 3, Week 8, n=0, 132, 0 0
TC 3, Week 16, n=0, 119, 0 0
TC 3, Week 24, n=0, 92, 0 0
TC 3, Week 32, n=0, 63, 0 5
TC 3, Week 40, n=0, 35, 0 4
TC 3, Week 48, n=0, 24, 0 7
TC 3, Week 56, n=0, 14, 0 2
TC 3, Week 64, n=0, 10, 0 2
TC 3, Week 72, n=0, 8, 0 5
TC 3, Week 80, n=0, 8, 0 5
TC 3, Week 88, n=0, 4, 0 3
TC 3, Week 96, n=0, 2, 0 1
TC 3, Week 104, n=0, 1, 0 1
TC 4, Week 8, n=0, 70, 0 0
TC 4, Week 16, n=0, 53, 0 0
TC 4, Week 24, n=0, 37, 0 0
TC 4, Week 32, n=0, 25, 0 4
TC 4, Week 40, n=0, 8, 0 0
TC 4, Week 48, n=0, 2, 0 1
TC 5, Week 8, n=0, 30, 0 0
TC 5, Week 16, n=0, 20, 0 0
TC 5, Week 24, n=0, 20, 0 1
TC 5, Week 32, n=0, 9, 0 2
TC 5, Week 40, n=0, 3, 0 2
TC 6, Week 8, n=0, 11, 0 0
TC 6, Week 16, n=0, 10, 0 0
TC 6, Week 24, n=0, 7, 0 0
TC 6, Week 32, n=0, 2, 0 0
TC 7, Week 8, n=0, 2, 0 0
TC 7, Week 16, n=0, 1, 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 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:
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.
Overall Number of Participants Analyzed 0 237 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 237, 0 197
TC 1, Week 16, n=0, 182, 0 156
TC 1, Week 24, n=0, 177, 0 152
TC 1, Week 32, n=0, 96, 0 88
TC 1, Week 40, n=0, 59, 0 51
TC 1, Week 48, n=0, 46, 0 40
TC 1, Week 56, n=0, 31, 0 26
TC 1, Week 64, n=0, 23, 0 18
TC 1, Week 72, n=0, 19, 0 16
TC 1, Week 80, n=0, 15, 0 13
TC 1, Week 88, n=0, 13, 0 11
TC 1, Week 96, n=0, 12, 0 9
TC 1, Week 104, n=0, 10, 0 9
TC 1, Week 112, n=0, 8, 0 7
TC 1, Week 120, n=0, 7, 0 6
TC 1, Week 128, n=0, 4, 0 4
TC 1, Week 136, n=0, 4, 0 4
TC 1, Week 144, n=0, 4, 0 4
TC 2, Week 8, n=0, 194, 0 170
TC 2, Week 16, n=0, 177, 0 155
TC 2, Week 24, n=0, 150, 0 128
TC 2, Week 32, n=0, 97, 0 82
TC 2, Week 40, n=0, 69, 0 60
TC 2, Week 48, n=0, 58, 0 48
TC 2, Week 56, n=0, 43, 0 35
TC 2, Week 64, n=0, 31, 0 28
TC 2, Week 72, n=0, 24, 0 20
TC 2, Week 80, n=0, 21, 0 17
TC 2, Week 88, n=0, 16, 0 14
TC 2, Week 96, n=0, 10, 0 10
TC 2, Week 104, n=0, 8, 0 8
TC 2, Week 112, n=0, 4, 0 4
TC 2, Week 120, n=0, 3, 0 3
TC 2, Week 128, n=0, 1, 0 1
TC 3, Week 8, n=0, 132, 0 118
TC 3, Week 16, n=0, 119, 0 105
TC 3, Week 24, n=0, 92, 0 81
TC 3, Week 32, n=0, 63, 0 57
TC 3, Week 40, n=0, 35, 0 32
TC 3, Week 48, n=0, 24, 0 21
TC 3, Week 56, n=0, 14, 0 12
TC 3, Week 64, n=0, 10, 0 9
TC 3, Week 72, n=0, 8, 0 8
TC 3, Week 80, n=0, 8, 0 7
TC 3, Week 88, n=0, 4, 0 4
TC 3, Week 96, n=0, 2, 0 2
TC 3, Week 104, n=0, 1, 0 1
TC 4, Week 8, n=0, 70, 0 66
TC 4, Week 16, n=0, 53, 0 49
TC 4, Week 24, n=0, 37, 0 34
TC 4, Week 32, n=0, 25, 0 23
TC 4, Week 40, n=0, 8, 0 7
TC 4, Week 48, n=0, 2, 0 2
TC 5, Week 8, n=0, 30, 0 26
TC 5, Week 16, n=0, 27, 0 24
TC 5, Week 24, n=0, 20, 0 19
TC 5, Week 32, n=0, 9, 0 9
TC 5, Week 40, n=0, 3, 0 3
TC 6, Week 8, n=0, 11, 0 9
TC 6, Week 16, n=0, 10, 0 9
TC 6, Week 24, n=0, 7, 0 6
TC 6, Week 32, n=0, 2, 0 2
TC 7, Week 8, n=0, 2, 0 2
TC 7, Week 16, n=0, 1, 0 1
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 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:
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.
Overall Number of Participants Analyzed 0 237 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 237, 0 209
TC 1, Week 16, n=0, 182, 0 163
TC 1, Week 24, n=0, 177, 0 150
TC 1, Week 32, n=0, 96, 0 89
TC 1, Week 40, n=0, 59, 0 50
TC 1, Week 48, n=0, 46, 0 40
TC 1, Week 56, n=0, 31, 0 26
TC 1, Week 64, n=0, 23, 0 18
TC 1, Week 72, n=0, 19, 0 16
TC 1, Week 80, n=0, 15, 0 14
TC 1, Week 88, n=0, 13, 0 10
TC 1, Week 96, n=0, 12, 0 10
TC 1, Week 104, n=0, 10, 0 9
TC 1, Week 112, n=0, 8, 0 7
TC 1, Week 120, n=0, 7, 0 6
TC 1, Week 128, n=0, 4, 0 4
TC 1, Week 136, n=0, 4, 0 4
TC 1, Week 144, n=0, 4, 0 4
TC 2, Week 8, n=0, 194, 0 174
TC 2, Week 16, n=0, 177, 0 162
TC 2, Week 24, n=0, 150, 0 136
TC 2, Week 32, n=0, 97, 0 85
TC 2, Week 40, n=0, 69, 0 63
TC 2, Week 48, n=0, 58, 0 51
TC 2, Week 56, n=0, 43, 0 37
TC 2, Week 64, n=0, 31, 0 29
TC 2, Week 72, n=0, 24, 0 22
TC 2, Week 80, n=0, 21, 0 19
TC 2, Week 88, n=0, 16, 0 15
TC 2, Week 96, n=0, 10, 0 10
TC 2, Week 104, n=0, 8, 0 8
TC 2, Week 112, n=0, 4, 0 4
TC 2, Week 120, n=0, 3, 0 3
TC 2, Week 128, n=0, 1, 0 1
TC 3, Week 8, n=0, 132, 0 120
TC 3, Week 16, n=0, 119, 0 108
TC 3, Week 24, n=0, 92, 0 81
TC 3, Week 32, n=0, 63, 0 58
TC 3, Week 40, n=0, 35, 0 33
TC 3, Week 48, n=0, 24, 0 20
TC 3, Week 56, n=0, 14, 0 13
TC 3, Week 64, n=0, 10, 0 8
TC 3, Week 72, n=0, 8, 0 8
TC 3, Week 80, n=0, 8, 0 7
TC 3, Week 88, n=0, 4, 0 4
TC 3, Week 96, n=0, 2, 0 2
TC 3, Week 104, n=0, 1, 0 1
TC 4, Week 8, n=0, 70, 0 68
TC 4, Week 16, n=0, 53, 0 51
TC 4, Week 24, n=0, 37, 0 35
TC 4, Week 32, n=0, 25, 0 24
TC 4, Week 40, n=0, 8, 0 8
TC 4, Week 48, n=0, 2, 0 2
TC 5, Week 8, n=0, 30, 0 27
TC 5, Week 16, n=0, 27, 0 26
TC 5, Week 24, n=0, 20, 0 18
TC 5, Week 32, n=0, 9, 0 9
TC 5, Week 40, n=0, 3, 0 3
TC 6, Week 8, n=0, 11, 0 10
TC 6, Week 16, n=0, 10, 0 9
TC 6, Week 24, n=0, 7, 0 7
TC 6, Week 32, n=0, 2, 0 2
TC 7, Week 8, n=0, 2, 0 2
TC 7, Week 16, n=0, 1, 0 1
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 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:
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.
Overall Number of Participants Analyzed 0 237 0
Measure Type: Number
Unit of Measure: Participants
TC 1, Week 8, n=0, 237, 0 216
TC 1, Week 16, n=0, 182, 0 166
TC 1, Week 24, n=0, 177, 0 160
TC 1, Week 32, n=0, 96, 0 90
TC 1, Week 40, n=0, 59, 0 51
TC 1, Week 48, n=0, 46, 0 42
TC 1, Week 56, n=0, 31, 0 29
TC 1, Week 64, n=0, 23, 0 19
TC 1, Week 72, n=0, 19, 0 15
TC 1, Week 80, n=0, 15, 0 14
TC 1, Week 88, n=0, 13, 0 12
TC 1, Week 96, n=0, 12, 0 11
TC 1, Week 104, n=0, 10, 0 10
TC 1, Week 112, n=0, 8, 0 8
TC 1, Week 120, n=0, 7, 0 6
TC 1, Week 128, n=0, 4, 0 4
TC 1, Week 136, n=0, 4, 0 4
TC 1, Week 144, n=0, 4, 0 3
TC 2, Week 8, n=0, 194, 0 181
TC 2, Week 16, n=0, 177, 0 164
TC 2, Week 24, n=0, 150, 0 140
TC 2, Week 32, n=0, 97, 0 91
TC 2, Week 40, n=0, 69, 0 65
TC 2, Week 48, n=0, 58, 0 54
TC 2, Week 56, n=0, 43, 0 40
TC 2, Week 64, n=0, 31, 0 29
TC 2, Week 72, n=0, 24, 0 23
TC 2, Week 80, n=0, 21, 0 19
TC 2, Week 88, n=0, 16, 0 15
TC 2, Week 96, n=0, 10, 0 10
TC 2, Week 104, n=0, 8, 0 8
TC 2, Week 112, n=0, 4, 0 4
TC 2, Week 120, n=0, 3, 0 3
TC 2, Week 128, n=0, 1, 0 1
TC 3, Week 8, n=0, 132, 0 128
TC 3, Week 16, n=0, 119, 0 113
TC 3, Week 24, n=0, 92, 0 88
TC 3, Week 32, n=0, 63, 0 61
TC 3, Week 40, n=0, 35, 0 34
TC 3, Week 48, n=0, 24, 0 24
TC 3, Week 56, n=0, 14, 0 13
TC 3, Week 64, n=0, 10, 0 8
TC 3, Week 72, n=0, 8, 0 8
TC 3, Week 80, n=0, 8, 0 8
TC 3, Week 88, n=0, 4, 0 4
TC 3, Week 96, n=0, 2, 0 2
TC 3, Week 104, n=0, 1, 0 1
TC 4, Week 8, n=0, 70, 0 68
TC 4, Week 16, n=0, 53, 0 52
TC 4, Week 24, n=0, 37, 0 37
TC 4, Week 32, n=0, 25, 0 24
TC 4, Week 40, n=0, 8, 0 8
TC 4, Week 48, n=0, 2, 0 2
TC 5, Week 8, n=0, 30, 0 28
TC 5, Week 16, n=0, 27, 0 26
TC 5, Week 24, n=0, 20, 0 20
TC 5, Week 32, n=0, 9, 0 9
TC 5, Week 40, n=0, 3, 0 3
TC 6, Week 8, n=0, 11, 0 10
TC 6, Week 16, n=0, 10, 0 10
TC 6, Week 24, n=0, 7, 0 6
TC 6, Week 32, n=0, 2, 0 2
TC 7, Week 8, n=0, 2, 0 2
TC 7, Week 16, n=0, 1, 0 1
39.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:
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.
Overall Number of Participants Analyzed 0 243 0
Measure Type: Number
Unit of Measure: Participants
DBP, TC 1, BL, <LLN, n=0, 242, 0 0
DBP, TC 1, PBL, <LLN, n=0, 243, 0 2
DBP, TC 1, BL, >ULN, n=0, 242, 0 1
DBP, TC 1, PBL, >ULN, n=0, 243, 0 3
SBP, TC 1, BL, <LLN, n=0, 242, 0 1
SBP, TC 1, PBL, <LLN, n=0, 243, 0 15
SBP, TC 1, BL, >ULN, n=0, 242, 0 1
SBP, TC 1, PBL, >ULN, n=0, 243, 0 15
HR, TC 1, BL, <LLN, n=0, 243, 0 0
HR, TC 1, PBL, <LLN, n=0, 243, 0 0
HR, TC 1, BL, >ULN, n=0, 243, 0 0
HR, TC 1, PBL, >ULN, n=0, 243, 0 0
DBP, TC 2, BL, <LLN, n=0, 196, 0 0
DBP, TC 2, PBL, <LLN, n=0, 198, 0 0
DBP, TC 2, BL, >ULN, n=0, 196, 0 0
DBP, TC 2, PBL, >ULN, n=0, 198, 0 2
SBP, TC 2, BL, <LLN, n=0, 196, 0 1
SBP, TC 2, PBL, <LLN, n=0, 198, 0 9
SBP, TC 2, BL, >ULN, n=0, 196, 0 0
SBP, TC 2, PBL, >ULN, n=0, 198, 0 12
HR, TC 2, BL, <LLN, n=0, 196, 0 0
HR, TC 2, PBL, <LLN, n=0, 198, 0 0
HR, TC 2, BL, >ULN, n=0, 196, 0 0
HR, TC 2, PBL, >ULN, n=0, 198, 0 2
DBP, TC 3, BL, <LLN, n=0, 136, 0 0
DBP, TC 3, PBL, <LLN, n=0, 136, 0 1
DBP, TC 3, BL, >ULN, n=0, 136, 0 0
DBP, TC 3, PBL, >ULN, n=0, 136, 0 1
SBP, TC 3, BL, <LLN, n=0, 136, 0 0
SBP, TC 3, PBL, <LLN, n=0, 136, 0 6
SBP, TC 3, BL, >ULN, n=0, 136, 0 1
SBP, TC 3, PBL, >ULN, n=0, 136, 0 3
HR, TC 3, BL, <LLN, n=0, 136, 0 0
HR, TC 3, PBL, <LLN, n=0, 136, 0 0
HR, TC 3, BL, >ULN, n=0, 136, 0 0
HR, TC 3, PBL, >ULN, n=0, 136, 0 1
DBP, TC 4, BL, <LLN, n=0, 72, 0 0
DBP, TC 4, PBL, <LLN, n=0, 72, 0 0
DBP, TC 4, BL, >ULN, n=0, 72, 0 0
DBP, TC 4, PBL, >ULN, n=0, 72, 0 1
SBP, TC 4, BL, <LLN, n=0, 72, 0 0
SBP, TC 4, PBL, <LLN, n=0, 72, 0 4
SBP, TC 4, BL, >ULN, n=0, 72, 0 0
SBP, TC 4, PBL, >ULN, n=0, 72, 0 2
HR, TC 4, BL, <LLN, n=0, 72, 0 0
HR, TC 4, PBL, <LLN, n=0, 72, 0 0
HR, TC 4, BL, >ULN, n=0, 72, 0 0
HR, TC 4, PBL, >ULN, n=0, 72, 0 0
DBP, TC 5, BL, <LLN, n=0, 31, 0 0
DBP, TC 5, PBL, <LLN, n=0, 31, 0 0
DBP, TC 5, BL, >ULN, n=0, 31, 0 0
DBP, TC 5, PBL, >ULN, n=0, 31, 0 0
SBP, TC 5, BL, <LLN, n=0, 31, 0 0
SBP, TC 5, PBL, <LLN, n=0, 31, 0 1
SBP, TC 5, BL, >ULN, n=0, 31, 0 0
SBP, TC 5, PBL, >ULN, n=0, 31, 0 0
HR, TC 5, BL, <LLN, n=0, 31, 0 0
HR, TC 5, PBL, <LLN, n=0, 31, 0 0
HR, TC 5, BL, >ULN, n=0, 31, 0 0
HR, TC 5, PBL, >ULN, n=0, 31, 0 0
DBP, TC 6, BL, <LLN, n=0, 11, 0 0
DBP, TC 6, PBL, <LLN, n=0, 11, 0 0
DBP, TC 6, BL, >ULN, n=0, 11, 0 0
DBP, TC 6, PBL, >ULN, n=0, 11, 0 0
SBP, TC 6, BL, <LLN, n=0, 11, 0 0
SBP, TC 6, PBL, <LLN, n=0, 11, 0 0
SBP, TC 6, BL, >ULN, n=0, 11, 0 0
SBP, TC 6, PBL, >ULN, n=0, 11, 0 1
HR, TC 6, BL, <LLN, n=0, 11, 0 0
HR, TC 6, PBL, <LLN, n=0, 11, 0 0
HR, TC 6, BL, >ULN, n=0, 11, 0 0
HR, TC 6, PBL, >ULN, n=0, 11, 0 0
DBP, TC 7, BL, <LLN, n=0, 2, 0 0
DBP, TC 7, PBL, <LLN, n=0, 2, 0 0
DBP, TC 7, BL, >ULN, n=0, 2, 0 0
DBP, TC 7, PBL, >ULN, n=0, 2, 0 0
SBP, TC 7, BL, <LLN, n=0, 2, 0 0
SBP, TC 7, PBL, <LLN, n=0, 2, 0 0
SBP, TC 7, BL, >ULN, n=0, 2, 0 0
SBP, TC 7, PBL, >ULN, n=0, 2, 0 0
HR, TC 7, BL, <LLN, n=0, 2, 0 0
HR, TC 7, PBL, <LLN, n=0, 2, 0 0
HR, TC 7, BL, >ULN, n=0, 2, 0 0
HR, TC 7, PBL, >ULN, n=0, 2, 0 0
40.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:
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.
Overall Number of Participants Analyzed 0 225 0
Measure Type: Number
Unit of Measure: Participants
Week 48, normal, n=0, 225, 0 150
Week 48, abnormal CS, n=0, 225, 0 2
Week 48, abnormal NCS, n=0, 225, 0 71
Week 48, NR, n=0, 225, 0 2
Week 72, normal, n=0, 202, 0 133
Week 72, abnormal CS, n=0, 202, 0 1
Week 72, abnormal NCS, n=0, 202, 0 67
Week 72, NR, n=0, 202, 0 1
Week 96, normal, n=0, 180, 0 119
Week 96, abnormal CS, n=0, 180, 0 0
Week 96, abnormal NCS, n=0, 180, 0 60
Week 96, NR, n=0, 180, 0 1
Week 120, normal, n=0, 167, 0 120
Week 120, abnormal CS, n=0, 167, 0 1
Week 120, abnormal NCS, n=0, 167, 0 46
Week 120, NR, n=0, 167, 0 0
Week 144, normal, n=0, 95, 0 68
Week 144, abnormal CS, n=0, 95, 0 1
Week 144, abnormal NCS, n=0, 95, 0 26
Week 144, NR, n=0, 95, 0 0
41.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. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.
Time Frame From baseline up to Week 144
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:
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.
Overall Number of Participants Analyzed 0 239 0
Measure Type: Number
Unit of Measure: Participants
Albumin, TC 1, BL, CC low, n=0, 234, 0 0
Albumin, TC 1, PBL, CC low, n=0, 239, 0 0
ALT, TC 1, BL, CC high, n=0, 234, 0 0
ALT, TC 1, PBL, CC high, n=0, 239, 0 3
ALP, TC 1, BL, CC high, n=0, 234, 0 0
ALP, TC 1, PBL, CC high, n=0, 239, 0 0
AST, TC 1, BL, CC high, n=0, 234, 0 0
AST, TC 1, PBL, CC high, n=0, 239, 0 1
TBIL, TC 1, BL, CC high, n=0, 234, 0 0
TBIL, TC 1, PBL, CC high, n=0, 239, 0 1
Calcium, TC 1, BL, CC low, n=0, 234, 0 0
Calcium, TC 1, PBL, CC low, n=0, 239, 0 1
CO2/BCO, TC 1, BL, CC low, n=0, 234, 0 9
CO2/BCO, TC 1, PBL, CC low, n=0, 239, 0 15
Chloride, TC 1, BL, CC low, n=0, 234, 0 0
Chloride, TC 1, PBL, CC low, n=0, 239, 0 0
CK, TC 1, BL, CC high, n=0, 234, 0 1
CK, TC 1, PBL, CC high, n=0, 239, 0 4
Creatinine, TC 1, BL, CC high, n=0, 234, 0 0
Creatinine, TC 1,PBL, CC high, n=0, 239, 0 0
GGT, TC 1, BL, CC high, n=0, 234, 0 11
GGT, TC 1, PBL, CC high, n=0, 239, 0 9
LDH, TC 1, BL, CC high, n=0, 234, 0 1
LDH, TC 1, PBL, CC high, n=0, 239, 0 1
Potassium, TC 1, BL, CC high, n=0, 234, 0 2
Potassium, TC 1, PBL, CC high, n=0, 239, 0 2
Potassium, TC 1, BL, CC low, n=0, 234, 0 0
Potassium, TC 1, PBL, CC low, n=0, 239, 0 0
Sodium, TC 1, BL, CC low, n=0, 234, 0 0
Sodium, TC 1, PBL, CC low, n=0, 239, 0 1
Total Protein, TC 1, BL, CC low, n=0, 234, 0 0
Total Protein, TC 1, PBL, CC low, n=0, 239, 0 0
Urea/BUN, TC 1, BL, CC high, n=0, 234, 0 0
Urea/BUN, TC 1, PBL, CC high, n=0, 239, 0 1
Uric acid, TC 1, BL, CC high, n=0, 234, 0 0
Uric acid, TC 1, PBL, CC high, n=0, 239, 0 0
Albumin, TC 2, BL, CC low, n=0, 177, 0 1
Albumin, TC 2, PBL, CC low, n=0, 196, 0 0
ALT, TC 2, BL, CC high, n=0, 177, 0 0
ALT, TC 2, PBL, CC high, n=0, 196, 0 2
ALP, TC 2, BL, CC high, n=0, 177, 0 1
ALP, TC 2, PBL, CC high, n=0, 196, 0 1
AST, TC 2, BL, CC high, n=0, 176, 0 0
AST, TC 2, PBL, CC high, n=0, 196, 0 1
TBIL, TC 2, BL, CC high, n=0, 177, 0 0
TBIL, TC 2, PBL, CC high, n=0, 196, 0 1
Calcium, TC 2, BL, CC low, n=0, 176, 0 1
Calcium, TC 2, PBL, CC low, n=0, 196, 0 0
CO2/BCO, TC 2, BL, CC low, n=0, 176, 0 5
CO2/BCO, TC 2, PBL, CC low, n=0, 196, 0 10
Chloride, TC 2, BL, CC low, n=0, 177, 0 0
Chloride, TC 2, PBL, CC low, n=0, 196, 0 1
CK, TC 2, BL, CC high, n=0, 177, 0 0
CK, TC 2, PBL, CC high, n=0, 196, 0 4
Creatinine, TC 2, BL, CC high, n=0, 177, 0 1
Creatinine, TC 2,PBL, CC high, n=0, 196, 0 0
GGT, TC 2, BL, CC high, n=0, 117, 0 3
GGT, TC 2, PBL, CC high, n=0, 196, 0 9
LDH, TC 2, BL, CC high, n=0, 176, 0 0
LDH, TC 2, PBL, CC high, n=0, 196, 0 0
Potassium, TC 2, BL, CC high, n=0, 176, 0 1
Potassium, TC 2, PBL, CC high, n=0, 196, 0 1
Potassium, TC 2, BL, CC low, n=0, 176, 0 1
Potassium, TC 2, PBL, CC low, n=0, 196, 0 1
Sodium, TC 2, BL, CC low, n=0, 177, 0 0
Sodium, TC 2, PBL, CC low, n=0, 196, 0 1
Total Protein, TC 2, BL, CC low, n=0, 177, 0 1
Total Protein, TC 2, PBL, CC low, n=0, 196, 0 0
Urea/BUN, TC 2, BL, CC high, n=0, 177, 0 1
Urea/BUN, TC 2, PBL, CC high, n=0, 196, 0 1
Uric acid, TC 2, BL, CC high, n=0, 177, 0 0
Uric acid, TC 2, PBL, CC high, n=0, 196, 0 0
Albumin, TC 3, BL, CC low, n=0, 116, 0 0
Albumin, TC 3, PBL, CC low, n=0, 134, 0 0
ALT, TC 3, BL, CC high, n=0, 116, 0 1
ALT, TC 3, PBL, CC high, n=0, 135, 0 2
ALP, TC 3, BL, CC high, n=0, 116, 0 1
ALP, TC 3, PBL, CC high, n=0, 135, 0 3
AST, TC 3, BL, CC high, n=0, 116, 0 0
AST, TC 3, PBL, CC high, n=0, 135, 0 2
TBIL, TC 3, BL, CC high, n=0, 116, 0 0
TBIL, TC 3, PBL, CC high, n=0, 135, 0 1
Calcium, TC 3, BL, CC low, n=0, 116, 0 0
Calcium, TC 3, PBL, CC low, n=0, 134, 0 1
CO2/BCO, TC 3, BL, CC low, n=0, 116, 0 2
CO2/BCO, TC 3, PBL, CC low, n=0, 134, 0 6
Chloride, TC 3, BL, CC low, n=0, 116, 0 0
Chloride, TC 3, PBL, CC low, n=0, 134, 0 0
CK, TC 3, BL, CC high, n=0, 116, 0 2
CK, TC 3, PBL, CC high, n=0, 135, 0 2
Creatinine, TC 3, BL, CC high, n=0, 116, 0 0
Creatinine, TC 3, PBL, CC high, n=0, 134, 0 1
GGT, TC 3, BL, CC high, n=0, 116, 0 5
GGT, TC 3, PBL, CC high, n=0, 134, 0 7
LDH, TC 3, BL, CC high, n=0, 116, 0 0
LDH, TC 3, PBL, CC high, n=0, 135, 0 1
Potassium, TC 3, BL, CC high, n=0, 116, 0 0
Potassium, TC 3, PBL, CC high, n=0, 134, 0 0
Potassium, TC 3, BL, CC low, n=0, 116, 0 0
Potassium, TC 3, PBL, CC low, n=0, 134, 0 2
Sodium, TC 3, BL, CC low, n=0, 116, 0 0
Sodium, TC 3, PBL, CC low, n=0, 134, 0 0
Total Protein, TC 3, BL, CC low, n=0, 116, 0 0
Total Protein, TC 3, PBL, CC low, n=0, 134, 0 0
Urea/BUN, TC 3, BL, CC high, n=0, 116, 0 1
Urea/BUN, TC 3, PBL, CC high, n=0, 134, 0 1
Uric acid, TC 3, BL, CC high, n=0, 116, 0 0
Uric acid, TC 3, PBL, CC high, n=0, 134, 0 1
Albumin, TC 4, BL, CC low, n=0, 67, 0 0
Albumin, TC 4, PBL, CC low, n=0, 72, 0 0
ALT, TC 4, BL, CC high, n=0, 67, 0 1
ALT, TC 4, PBL, CC high, n=0, 72, 0 2
ALP, TC 4, BL, CC high, n=0, 67, 0 0
ALP, TC 4, PBL, CC high, n=0, 72, 0 1
AST, TC 4, BL, CC high, n=0, 67, 0 1
AST, TC 4, PBL, CC high, n=0, 72, 0 2
TBIL, TC 4, BL, CC high, n=0, 67, 0 0
TBIL, TC 4, PBL, CC high, n=0, 72, 0 0
Calcium, TC 4, BL, CC low, n=0, 67, 0 0
Calcium, TC 4, PBL, CC low, n=0, 72, 0 0
CO2/BCO, TC 4, BL, CC low, n=0, 67, 0 1
CO2/BCO, TC 4, PBL, CC low, n=0, 72, 0 2
Chloride, TC 4, BL, CC low, n=0, 67, 0 0
Chloride, TC 4, PBL, CC low, n=0, 72, 0 0
CK, TC 4, BL, CC high, n=0, 67, 0 0
CK, TC 4, PBL, CC high, n=0, 72, 0 1
Creatinine, TC 4, BL, CC high, n=0, 67, 0 1
Creatinine, TC 4, PBL, CC high, n=0, 72, 0 1
GGT, TC 4, BL, CC high, n=0, 67, 0 2
GGT, TC 4, PBL, CC high, n=0, 72, 0 3
LDH, TC 4, BL, CC high, n=0, 67, 0 0
LDH, TC 4, PBL, CC high, n=0, 72, 0 0
Potassium, TC 4, BL, CC high, n=0, 67, 0 0
Potassium, TC 4, PBL, CC high, n=0, 72, 0 0
Potassium, TC 4, BL, CC low, n=0, 67, 0 0
Potassium, TC 4, PBL, CC low, n=0, 72, 0 0
Sodium, TC 4, BL, CC low, n=0, 67, 0 0
Sodium, TC 4, PBL, CC low, n=0, 72, 0 0
Total Protein, TC 4, BL, CC low, n=0, 67, 0 0
Total Protein, TC 4, PBL, CC low, n=0, 72, 0 0
Urea/BUN, TC 4, BL, CC high, n=0, 67, 0 0
Urea/BUN, TC 4, PBL, CC high, n=0, 72, 0 1
Uric acid, TC 4, BL, CC high, n=0, 67, 0 0
Uric acid, TC 4, PBL, CC high, n=0, 72, 0 0
Albumin, TC 5, BL, CC low, n=0, 29, 0 0
Albumin, TC 5, PBL, CC low, n=0, 31, 0 0
ALT, TC 5, BL, CC high, n=0, 29, 0 0
ALT, TC 5, PBL, CC high, n=0, 31, 0 1
ALP, TC 5, BL, CC high, n=0, 29, 0 0
ALP, TC 5, PBL, CC high, n=0, 31, 0 1
AST, TC 5, BL, CC high, n=0, 29, 0 0
AST, TC 5, PBL, CC high, n=0, 31, 0 0
TBIL, TC 5, BL, CC high, n=0, 29, 0 0
TBIL, TC 3, PBL, CC high, n=0, 31, 0 0
Calcium, TC 5, BL, CC low, n=0, 29, 0 0
Calcium, TC 5, PBL, CC low, n=0, 31, 0 0
CO2/BCO, TC 5, BL, CC low, n=0, 29, 0 0
CO2/BCO, TC 5, PBL, CC low, n=0, 31, 0 0
Chloride, TC 5, BL, CC low, n=0, 29, 0 0
Chloride, TC 5, PBL, CC low, n=0, 31, 0 0
CK, TC 5, BL, CC high, n=0, 29, 0 0
CK, TC 5, PBL, CC high, n=0, 31, 0 1
Creatinine, TC 5, BL, CC high, n=0, 29, 0 0
Creatinine, TC 5, PBL, CC high, n=0, 31, 0 0
GGT, TC 5, BL, CC high, n=0, 29, 0 0
GGT, TC 5, PBL, CC high, n=0, 31, 0 1
LDH, TC 5, BL, CC high, n=0, 29, 0 0
LDH, TC 5, PBL, CC high, n=0, 31, 0 0
Potassium, TC 5, BL, CC high, n=0, 29, 0 0
Potassium, TC 5, PBL, CC high, n=0, 31, 0 0
Potassium, TC 5, BL, CC low, n=0, 29, 0 0
Potassium, TC 5, PBL, CC low, n=0, 31, 0 0
Sodium, TC 5, BL, CC low, n=0, 29, 0 0
Sodium, TC 5, PBL, CC low, n=0, 31, 0 0
Total Protein, TC 5, BL, CC low, n=0, 29, 0 0
Total Protein, TC 5, PBL, CC low, n=0, 31, 0 0
Urea/BUN, TC 5, BL, CC high, n=0, 29, 0 0
Urea/BUN, TC 5, PBL, CC high, n=0, 31, 0 0
Uric acid, TC 5, BL, CC high, n=0, 29, 0 0
Uric acid, TC 5, PBL, CC high, n=0, 31, 0 0
Albumin, TC 6, BL, CC low, n=0, 11, 0 0
Albumin, TC 6, PBL, CC low, n=0, 11, 0 0
ALT, TC 6, BL, CC high, n=0, 11, 0 0
ALT, TC 6, PBL, CC high, n=0, 11, 0 0
ALP, TC 6, BL, CC high, n=0, 11, 0 0
ALP, TC 6, PBL, CC high, n=0, 11, 0 0
AST, TC 6, BL, CC high, n=0, 10, 0 0
AST, TC 6, PBL, CC high, n=0, 11, 0 0
TBIL, TC 6, BL, CC high, n=0, 11, 0 0
TBIL, TC 6, PBL, CC high, n=0, 11, 0 0
Calcium, TC 6, BL, CC low, n=0, 10, 0 0
Calcium, TC 6, PBL, CC low, n=0, 11, 0 0
CO2/BCO, TC 6, BL, CC low, n=0, 10, 0 0
CO2/BCO, TC 6, PBL, CC low, n=0, 11, 0 1
Chloride, TC 6, BL, CC low, n=0, 11, 0 0
Chloride, TC 6, PBL, CC low, n=0, 11, 0 0
CK, TC 6, BL, CC high, n=0, 11, 0 0
CK, TC 6, PBL, CC high, n=0, 11, 0 0
Creatinine, TC 6, BL, CC high, n=0, 11, 0 0
Creatinine, TC 6, PBL, CC high, n=0, 11, 0 0
GGT, TC 6, BL, CC high, n=0, 11, 0 0
GGT, TC 6, PBL, CC high, n=0, 11, 0 0
LDH, TC 6, BL, CC high, n=0, 10, 0 0
LDH, TC 6, PBL, CC high, n=0, 11, 0 0
Potassium, TC 6, BL, CC high, n=0, 10, 0 0
Potassium, TC 6, PBL, CC high, n=0, 11, 0 0
Potassium, TC 6, BL, CC low, n=0, 10, 0 0
Potassium, TC 6, PBL, CC low, n=0, 11, 0 0
Sodium, TC 6, BL, CC low, n=0, 11, 0 0
Sodium, TC 6, PBL, CC low, n=0, 11, 0 0
Total Protein, TC 6, BL, CC low, n=0, 11, 0 0
Total Protein, TC 6, PBL, CC low, n=0, 11, 0 0
Urea/BUN, TC 6, BL, CC high, n=0, 11, 0 0
Urea/BUN, TC 6, PBL, CC high, n=0, 11, 0 0
Uric acid, TC 6, BL, CC high, n=0, 11, 0 0
Uric acid, TC 6, PBL, CC high, n=0, 11, 0 0
Albumin, TC 7, BL, CC low, n=0, 2, 0 0
Albumin, TC 7, PBL, CC low, n=0, 2, 0 0
ALT, TC 7, BL, CC high, n=0, 2, 0 0
ALT, TC 7, PBL, CC high, n=0, 2, 0 0
ALP, TC 7, BL, CC high, n=0, 2, 0 0
ALP, TC 7, PBL, CC high, n=0, 2, 0 0
AST, TC 7, BL, CC high, n=0, 2, 0 0
AST, TC 7, PBL, CC high, n=0, 2, 0 0
TBIL, TC 7, BL, CC high, n=0, 2, 0 0
TBIL, TC 7, PBL, CC high, n=0, 2, 0 0
Calcium, TC 7, BL, CC low, n=0, 2, 0 0
Calcium, TC 7, PBL, CC low, n=0, 2, 0 0
CO2/BCO, TC 7, BL, CC low, n=0, 2, 0 0
CO2/BCO, TC 7, PBL, CC low, n=0, 2, 0 0
Chloride, TC 7, BL, CC low, n=0, 2, 0 0
Chloride, TC 7, PBL, CC low, n=0, 2, 0 0
CK, TC 7, BL, CC high, n=0, 2, 0 0
CK, TC 7, PBL, CC high, n=0, 2, 0 0
Creatinine, TC 7, BL, CC high, n=0, 2, 0 0
Creatinine, TC 7, PBL, CC high, n=0, 2, 0 0
GGT, TC 7, BL, CC high, n=0, 2, 0 0
GGT, TC 7, PBL, CC high, n=0, 2, 0 0
LDH, TC 7, BL, CC high, n=0, 2, 0 0
LDH, TC 7, PBL, CC high, n=0, 2, 0 0
Potassium, TC 7, BL, CC high, n=0, 2, 0 0
Potassium, TC 7, PBL, CC high, n=0, 2, 0 0
Potassium, TC 7, BL, CC low, n=0, 2, 0 0
Potassium, TC 7, PBL, CC low, n=0, 2, 0 0
Sodium, TC 7, BL, CC low, n=0, 2, 0 0
Sodium, TC 7, PBL, CC low, n=0, 2, 0 0
Total Protein, TC 7, BL, CC low, n=0, 2, 0 0
Total Protein, TC 7, PBL, CC low, n=0, 2, 0 0
Urea/BUN, TC 7, BL, CC high, n=0, 2, 0 0
Urea/BUN, TC 7, PBL, CC high, n=0, 2, 0 0
Uric acid, TC 7, BL, CC high, n=0, 2, 0 0
Uric acid, TC 7, PBL, CC high, n=0, 2, 0 0
42.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 (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.
Time Frame From baseline up to Week 144
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:
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.
Overall Number of Participants Analyzed 0 239 0
Measure Type: Number
Unit of Measure: Participants
Eosinophils, TC 1, BL, CC high, n=0, 224, 0 2
Eosinophils, TC 1, PBL, CC high, n=0, 239, 0 4
HCT, TC 1, BL, CC low, n=0, 224, 0 0
HCT, TC 1, PBL, CC low, n=0, 239, 0 2
Hb, TC 1, BL, CC low, n=0, 224, 0 3
Hb, TC 1, PBL, CC low, n=0, 239, 0 6
Lymphocytes, TC 1, BL, CC low, n=0, 232, 0 1
Lymphocytes, TC 1, PBL, CC low, n=0, 239, 0 1
PC, TC 1, BL, CC high, n=0, 221, 0 1
PC, TC 1, PBL, CC high, n=0, 239, 0 3
RBC count, TC 1, BL, CC low, n=0, 224, 0 1
RBC count, TC 1, PBL, CC low, n=0, 239, 0 1
TNUE, TC 1, BL, CC low, n=0, 224, 0 0
TNUE, TC 1, PBL, CC low, n=0, 239, 0 8
TNUE, TC 1, BL, CC high, n=0, 224, 0 5
TNUE, TC 1,PBL, CC high, n=0, 239, 0 6
WBC count, TC 1, BL, CC low, n=0, 224, 0 0
WBC count, TC 1, PBL, CC low, n=0, 239, 0 1
WBC count, TC 1, BL, CC high, n=0, 224, 0 1
WBC count, TC 1, PBL, CC high, n=0, 239, 0 1
Eosinophils, TC 2, BL, CC high, n=0, 171, 0 2
Eosinophils, TC 2, PBL, CC high, n=0, 195, 0 6
HCT, TC 2, BL, CC low, n=0, 173, 0 0
HCT, TC 2, PBL, CC low, n=0, 195, 0 0
Hb, TC 2, BL, CC low, n=0, 172, 0 0
Hb, TC 2, PBL, CC low, n=0, 195, 0 1
Lymphocytes, TC 2, BL, CC low, n=0, 177, 0 0
Lymphocytes, TC 2, PBL, CC low, n=0, 196, 0 1
PC, TC 2, BL, CC high, n=0, 170, 0 0
PC, TC 2, PBL, CC high, n=0, 195, 0 0
RBC count, TC 2, BL, CC low, n=0, 172, 0 0
RBC count, TC 2, PBL, CC low, n=0, 195, 0 0
TNUE, TC 2, BL, CC low, n=0, 171, 0 1
TNUE, TC 2, PBL, CC low, n=0, 195, 0 3
TNUE, TC 2, BL, CC high, n=0, 171, 0 0
TNUE, TC 2,PBL, CC high, n=0, 195, 0 1
WBC count, TC 2, BL, CC low, n=0, 171, 0 1
WBC count, TC 2, PBL, CC low, n=0, 195, 0 1
WBC count, TC 2, BL, CC high, n=0, 171, 0 0
WBC count, TC 2, PBL, CC high, n=0, 195, 0 1
Eosinophils, TC 3, BL, CC high, n=0, 114, 0 2
Eosinophils, TC 3, PBL, CC high, n=0, 134, 0 2
HCT, TC 3, BL, CC low, n=0, 115, 0 0
HCT, TC 3, PBL, CC low, n=0, 134, 0 0
Hb, TC 3, BL, CC low, n=0, 115, 0 0
Hb, TC 3, PBL, CC low, n=0, 134, 0 0
Lymphocytes, TC 3, BL, CC low, n=0, 117, 0 0
Lymphocytes, TC 3, PBL, CC low, n=0, 134, 0 0
PC, TC 3, BL, CC high, n=0, 115, 0 0
PC, TC 3, PBL, CC high, n=0, 134, 0 0
RBC count, TC 3, BL, CC low, n=0, 115, 0 0
RBC count, TC 3, PBL, CC low, n=0, 134, 0 0
TNUE, TC 3, BL, CC low, n=0, 114, 0 0
TNUE, TC 3, PBL, CC low, n=0, 134, 0 2
TNUE, TC 3, BL, CC high, n=0, 114, 0 0
TNUE, TC 3,PBL, CC high, n=0, 134, 0 0
WBC count, TC 3, BL, CC low, n=0, 114, 0 0
WBC count, TC 3, PBL, CC low, n=0, 134, 0 0
WBC count, TC 3, BL, CC high, n=0, 114, 0 0
WBC count, TC 3, PBL, CC high, n=0, 134, 0 0
Eosinophils, TC 4, BL, CC high, n=0, 66, 0 1
Eosinophils, TC 4, PBL, CC high, n=0, 72, 0 1
HCT, TC 4, BL, CC low, n=0, 66, 0 0
HCT, TC 4, PBL, CC low, n=0, 72, 0 0
Hb, TC 4, BL, CC low, n=0, 66, 0 0
Hb, TC 4, PBL, CC low, n=0, 72, 0 0
Lymphocytes, TC 4, BL, CC low, n=0, 67, 0 0
Lymphocytes, TC 4, PBL, CC low, n=0, 72, 0 0
PC, TC 4, BL, CC high, n=0, 65, 0 0
PC, TC 4, PBL, CC high, n=0, 72, 0 0
RBC count, TC 4, BL, CC low, n=0, 66, 0 0
RBC count, TC 4, PBL, CC low, n=0, 72, 0 0
TNUE, TC 4, BL, CC low, n=0, 66, 0 0
TNUE, TC 4, PBL, CC low, n=0, 72, 0 5
TNUE, TC 4, BL, CC high, n=0, 66, 0 0
TNUE, TC 4,PBL, CC high, n=0, 72, 0 0
WBC count, TC 4, BL, CC low, n=0, 66, 0 0
WBC count, TC 4, PBL, CC low, n=0, 72, 0 0
WBC count, TC 4, BL, CC high, n=0, 66, 0 0
WBC count, TC 4, PBL, CC high, n=0, 72, 0 0
Eosinophils, TC 5, BL, CC high, n=0, 29, 0 0
Eosinophils, TC 5, PBL, CC high, n=0, 31, 0 1
HCT, TC 5, BL, CC low, n=0, 29, 0 0
HCT, TC 5, PBL, CC low, n=0, 31, 0 0
Hb, TC 5, BL, CC low, n=0, 29, 0 0
Hb, TC 5, PBL, CC low, n=0, 31, 0 0
Lymphocytes, TC 5, BL, CC low, n=0, 29, 0 0
Lymphocytes, TC 5, PBL, CC low, n=0, 31, 0 0
PC, TC 5, BL, CC high, n=0, 29, 0 0
PC, TC 5, PBL, CC high, n=0, 31, 0 0
RBC count, TC 5, BL, CC low, n=0, 29, 0 0
RBC count, TC 5, PBL, CC low, n=0, 31, 0 0
TNUE, TC 5, BL, CC low, n=0, 29, 0 2
TNUE, TC 5, PBL, CC low, n=0, 31, 0 0
TNUE, TC 5, BL, CC high, n=0, 29, 0 0
TNUE, TC 5,PBL, CC high, n=0, 31, 0 0
WBC count, TC 5, BL, CC low, n=0, 29, 0 0
WBC count, TC 5, PBL, CC low, n=0, 31, 0 0
WBC count, TC 5, BL, CC high, n=0, 29, 0 0
WBC count, TC 5, PBL, CC high, n=0, 31, 0 0
Eosinophils, TC 6, BL, CC high, n=0, 11, 0 0
Eosinophils, TC 6, PBL, CC high, n=0, 11, 0 0
HCT, TC 6, BL, CC low, n=0, 11, 0 0
HCT, TC 6, PBL, CC low, n=0, 11, 0 0
Hb, TC 6, BL, CC low, n=0, 11, 0 1
Hb, TC 6, PBL, CC low, n=0, 11, 0 0
Lymphocytes, TC 6, BL, CC low, n=0, 11, 0 0
Lymphocytes, TC 6, PBL, CC low, n=0, 11, 0 0
PC, TC 6, BL, CC high, n=0, 11, 0 0
PC, TC 6, PBL, CC high, n=0, 11, 0 0
RBC count, TC 6, BL, CC low, n=0, 11, 0 0
RBC count, TC 6, PBL, CC low, n=0, 11, 0 0
TNUE, TC 6, BL, CC low, n=0, 11, 0 0
TNUE, TC 6, PBL, CC low, n=0, 11, 0 0
TNUE, TC 6, BL, CC high, n=0, 11, 0 0
TNUE, TC 6,PBL, CC high, n=0, 11, 0 0
WBC count, TC 6, BL, CC low, n=0, 11, 0 0
WBC count, TC 6, PBL, CC low, n=0, 11, 0 0
WBC count, TC 6, BL, CC high, n=0, 11, 0 0
WBC count, TC 6, PBL, CC high, n=0, 11, 0 0
Eosinophils, TC 7, BL, CC high, n=0, 2, 0 0
Eosinophils, TC 7, PBL, CC high, n=0, 2, 0 0
HCT, TC 7, BL, CC low, n=0, 2, 0 0
HCT, TC 7, PBL, CC low, n=0, 2, 0 0
Hb, TC 7, BL, CC low, n=0, 2, 0 0
Hb, TC 7, PBL, CC low, n=0, 2, 0 0
Lymphocytes, TC 7, BL, CC low, n=0, 2, 0 0
Lymphocytes, TC 7, PBL, CC low, n=0, 2, 0 0
PC, TC 7, BL, CC high, n=0, 2, 0 0
PC, TC 7, PBL, CC high, n=0, 2, 0 0
RBC count, TC 7, BL, CC low, n=0, 2, 0 0
RBC count, TC 7, PBL, CC low, n=0, 2, 0 0
TNUE, TC 7, BL, CC low, n=0, 2, 0 0
TNUE, TC 7, PBL, CC low, n=0, 2, 0 0
TNUE, TC 7, BL, CC high, n=0, 2, 0 0
TNUE, TC 7,PBL, CC high, n=0, 2, 0 0
WBC count, TC 7, BL, CC low, n=0, 2, 0 0
WBC count, TC 7, PBL, CC low, n=0, 2, 0 0
WBC count, TC 7, BL, CC high, n=0, 2, 0 0
WBC count, TC 7, PBL, CC high, n=0, 2, 0 0
43.Secondary Outcome
Title Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)
Hide Description Only those parameters for a particular flag (<LLN or >ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):<0.31ng/L and Serum amyloid A: <1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: >6 units; RF-IgG:>6 units; RF-IgM:>6 units; Anti-CCP:>19.9999 units; B-ls:>1343.3 ng/L; IL-6: >5 ng/L; RF:>11.9999 kilounits (KU)/L; Serum amyloid A:>82432 ng/mL.
Time Frame From baseline up to Week 144
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:
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.
Overall Number of Participants Analyzed 0 205 0
Measure Type: Number
Unit of Measure: Participants
RF IgA, TC 1, BL, >ULN, n=0, 205, 0 137
RF IgA, TC 1, PBL, >ULN, n=0, 169, 0 93
RF IgG, TC 1, BL, >ULN, n=0, 205, 0 114
RF IgG, TC 1, PBL, >ULN, n=0, 169, 0 67
RF IgM, TC 1, BL, >ULN, n=0, 205, 0 173
RF IgM, TC 1, PBL, >ULN, n=0, 169, 0 129
Anti-CCP, TC 1, BL, >ULN, n=0, 207, 0 185
Anti-CCP, TC 1, PBL, >ULN, n=0, 168, 0 140
B-ls, TC 1, BL, <LLN, n=0, 203, 0 21
B-ls, TC 1, PBL, <LLN, n=0, 206, 0 4
B-ls, TC 1, BL, >ULN, n=0, 203, 0 12
B-ls, TC 1, PBL, >ULN, n=0, 206, 0 167
Il-6, TC 1, BL, >ULN, n=0, 205, 0 144
IL-6, TC 1, PBL, >ULN, n=0, 138, 0 79
Serum amyloid A, TC 1, BL, >ULN, n=0, 204, 0 129
Serum amyloid A, TC 1, PBL, >ULN, n=0, 138, 0 68
RF IgA, TC 2, BL, >ULN, n=0, 59, 0 32
RF IgA, TC 2, PBL, >ULN, n=0, 111, 0 51
RF IgG, TC 2, BL, >ULN, n=0, 59, 0 20
RF IgG, TC 2, PBL, >ULN, n=0, 111, 0 38
RF IgM, TC 2, BL, >ULN, n=0, 59, 0 45
RF IgM, TC 2, PBL, >ULN, n=0, 111, 0 80
Anti-CCP, TC 2, BL, >ULN, n=0, 60, 0 51
Anti-CCP, TC 2, PBL, >ULN, n=0, 111, 0 93
B-ls, TC 2, BL, <LLN, n=0, 81, 0 1
B-ls, TC 2, PBL, <LLN, n=0, 88, 0 1
B-ls, TC 2, BL, >ULN, n=0, 81, 0 60
B-ls, TC 2, PBL, >ULN, n=0, 88, 0 72
Il-6, TC 2, BL, >ULN, n=0, 52, 0 23
IL-6, TC 2, PBL, >ULN, n=0, 23, 0 8
Serum amyloid A, TC 2, BL, >ULN, n=0, 52, 0 18