Arthritis, Rheumatoid
Conditions
Brief summary
A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.
Detailed description
All patients who fulfill the eligibility criteria for this trial , will initiate at least one treatment course of ofatumumab, and depending of subsequent worsening in disease activity will be eligible to received further treatment through the 156 week treatment period: a maximum of a further 8 treatment courses will be given at individualized time intervals . The interval between each treatment course will be at least 16 weeks with the last treatment course given no later than week 130 after baseline (Visit 2A). After each treatment course the patients will attend their next trial visit 8 weeks after Infusion 1, followed by trial visits every 4 weeks up to Week 24, and subsequently every 8 weeks until the next treatment course. After completing the Treatment Period or after withdrawing from the Treatment Period prematurely patients will be followed every 12 weeks (Follow-up Period) until CD19+ cells &/or IgG levels have returned to baseline or normal levels.
Interventions
DRUGofatumumab
1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously received ofatumumab or placebo in Trial Hx-CD20-403. * Patients on methotrexate therapy (7.5 - 25 mg/week, p.o., i.m., and/or s.c.). * Oral corticosteroids therapy (≤ 10 mg/day prednisolone or equivalent). * Active disease at the time of screening as defined by: * 3 swollen joints (of 28 joints assessed) and ≥ 3 tender joints (of 28 joints assessed), DAS28≥3.2 (based on ESR)
Exclusion criteria
* Use of DMARDs other than methotrexate or exposure to other cell depleting therapy, including investigational compounds \< 6 months prior to Visit 2 A. * Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening). * Breast feeding women or women with a positive pregnancy test at Visit 1 (screening). * Received anti-cancer therapy, corticosteroids (intra-articular, i.m., or i.v.), or live/attenuated vaccinations, or exposure to cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents \< 5 years prior to screening. * Past or current malignancy, except for Cervical carcinoma Stage 1B or less, Non-invasive basal cell and squamous cell skin carcinoma, Malignant melanoma with a complete response of a duration of \> 10 years, or other cancer diagnoses with a complete response of a duration of \> 5 years. * Chronic or ongoing active infectious disease requiring systemic treatment. * Clinically significant cardiac disease, or history of significant cerebrovascular disease. Significant concurrent, uncontrolled medical conditions, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease * Known or suspected HIV positive, positive serology for hepatitis B (HB), positive test for Hepatitis C, or positive plasma or white cell JC virus (JCV) PCR (either compartment). * A circulating IgG level \<lower limit of normal. * Known hypersensitivity to components of the investigational medicinal product. * Patients known or suspected of not being able to comply with a study protocol. * Women of child bearing potential not will to use adequate contraception during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Withdrawal | From Baseline up to 144 weeks | Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle. |
| Time to Re-treatment in Each Treatment Course | Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3. The study was terminated by the sponsor after Treatment Course 7; therefore, there are no re-treatment data available for Treatment Course 7. |
| Ofatumumab Serum Concentration | Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi | Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab. |
| Number of Participants Achieving American College of Rheumatology (ACR)20 | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants Achieving ACR50 | Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants Achieving ACR70 | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score \<=3.2 and \>1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score \<=3.2 and between \>0.6 and \<=1.2 IfB; DAS28 score between \>3.2 and \<=5.1 and \>1.2 IfB; DAS28 score between \>3.2 and \<=5.1 and between \>0.6 and \<=1.2 IfB; DAS28 score \>5.1 and \>1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ) | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants With the Indicated Global Disease Assessment Using the VAS | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | The participant and the physician independantly used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants With the Indicated Pain Score | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Number of Participants With HAHA Response | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Whole Blood Transcriptional Profiles | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated. |
| Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions. |
| CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions. |
| Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle. |
| Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaulation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis. |
| Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition. |
| Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in automimmune diseases. It regulates the immunnoglobin (antibody produced by B cells that is used by the immune system to indentify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood). |
| Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition. |
| Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab. |
| Assessment of Total Protein (TP) and Albumin | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases. |
| Assessment of Total Bilirubin (TB) and Creatinine | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected to evaluatate TB and creatinine levles. TB evlauation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaulation is performed to assess the renal condition (condition of the kidneys). |
| Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver. |
| Assessment of Blood Urea Nitrogen (BUN) | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to asssess the renal function of the participants. |
| Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk | The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses.Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI. |
| Assessment of Heart Rate (HR) | BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk | The HR of the participants was measured to assess the condition of the heart.HR was measured BI and post the first (A) and second (B) infusins during all 7 treatment courses.Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI. |
| Assessment of Body Temperature (BT) | BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk | The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT.The BT of the participants was measured before BI and PI A and B during all 7 treatment courses.Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI. |
| Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis. |
| Number of Participants With Normal and Abnormal Electrocardiogram Readings | 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded. |
| Ratio of CD 4+/CD8+ | Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks. | Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated. |
Countries
Denmark, Hungary, Poland, United Kingdom, United States
Participant flow
Recruitment details
Participants who previously participated in Study OFA112657 (NCT00291928) and who fulfilled the eligibility criteria were offered participation in this study (111752; NCT00655824).
Pre-assignment details
A participant was considered to have completed the study when the Investigator decided that the participant had completed the treatment phase and recorded this in the Case Report Form. Completion was not based on having completed a set number of treatment courses.
Participants by arm
| Arm | Count |
|---|---|
| Ofatumumab 700 mg IV Infusion Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed. | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Deterioration of Trial Disease | 2 |
| Overall Study | Early Termination of Study by Sponsor | 74 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Ofatumumab 700 mg IV Infusion |
|---|---|
| Age, Continuous | 52.9 Years STANDARD_DEVIATION 10.73 |
| Race/Ethnicity, Customized Caucasian | 92 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 92 |
| serious Total, serious adverse events | 11 / 92 |
Outcome results
Primary
Time to Treatment Withdrawal
Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.
Time frame: From Baseline up to 144 weeks
Population: Full Analysis Set (FAS) Population: all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment.
Secondary
Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT)
Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 1, Baseline; n=92 | 20.4 Units per liter (U/L) | Standard Deviation 11.71 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 1, Week 104; n=1 | 16.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 2, Baseline; n=73 | 21.8 Units per liter (U/L) | Standard Deviation 11.99 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 2, Week 80; n=1 | 19.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 3, Baseline; n=53 | 20.5 Units per liter (U/L) | Standard Deviation 15.4 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 3, Week 64; n=1 | 36.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 4, Baseline; n=20 | 22.7 Units per liter (U/L) | Standard Deviation 12.39 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 4, Week 40; n=1 | 19.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 5, Baseline; n=8 | 19.0 Units per liter (U/L) | Standard Deviation 5.04 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 5, Week 24; n=2 | 15.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 6, Baseline; n=4 | 23.5 Units per liter (U/L) | Standard Deviation 9.43 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 6, Week 16; n=2 | 24.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 7, Baseline; n=2 | 18.5 Units per liter (U/L) | Standard Deviation 2.12 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | ALT, Treatment Course 7, Week 8; n=2 | 22.0 Units per liter (U/L) | Standard Deviation 4.24 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 1, Baseline; n=92 | 21.1 Units per liter (U/L) | Standard Deviation 9.01 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 1, Week 104; n=1 | 17.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 2, Baseline; n=73 | 22.8 Units per liter (U/L) | Standard Deviation 8.96 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 2, Week 80; n=1 | 21.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 3, Baseline; n=53 | 21.8 Units per liter (U/L) | Standard Deviation 10.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 3, Week 64; n=1 | 21.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 4, Baseline; n=20 | 21.2 Units per liter (U/L) | Standard Deviation 6.47 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 4, Week 40; n=1 | 23.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 5, Baseline; n=8 | 22.4 Units per liter (U/L) | Standard Deviation 7.78 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 5, Week 24; n=2 | 18.0 Units per liter (U/L) | Standard Deviation 0 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 6, Baseline; n=4 | 25.3 Units per liter (U/L) | Standard Deviation 8.77 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 6, Week 16; n=2 | 23.5 Units per liter (U/L) | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 7, Baseline; n=2 | 22.5 Units per liter (U/L) | Standard Deviation 4.95 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AST, Treatment Course 7, Week 8; n=2 | 21.5 Units per liter (U/L) | Standard Deviation 0.71 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 1, Baseline; n=92 | 79.4 Units per liter (U/L) | Standard Deviation 27.8 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 1, Week 104; n=1 | 60.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 2, Baseline; n=73 | 73.3 Units per liter (U/L) | Standard Deviation 23.76 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 2, Week 80; n=1 | 79.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 3, Baseline; n=53 | 70.5 Units per liter (U/L) | Standard Deviation 22.18 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 3, Week 64; n=1 | 61.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 4, Baseline; n=20 | 66.2 Units per liter (U/L) | Standard Deviation 15.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 4, Week 40; n=1 | 77.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 5, Baseline; n=8 | 68.0 Units per liter (U/L) | Standard Deviation 25.03 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 5, Week 24; n=2 | 52.0 Units per liter (U/L) | Standard Deviation 14.14 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 6, Baseline; n=4 | 59.5 Units per liter (U/L) | Standard Deviation 26.51 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 6, Week 16; n=2 | 49.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 7, Baseline; n=2 | 47.5 Units per liter (U/L) | Standard Deviation 2.12 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | AP, Treatment Course 7, Week 8; n=2 | 45.0 Units per liter (U/L) | Standard Deviation 2.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 1, Baseline; n=92 | 22.2 Units per liter (U/L) | Standard Deviation 18.51 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 1, Week 104; n=1 | 16.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 2, Baseline; n=73 | 22.0 Units per liter (U/L) | Standard Deviation 20.88 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 2, Week 80; n=1 | 21.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 3, Baseline; n=53 | 19.0 Units per liter (U/L) | Standard Deviation 12.78 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 3, Week 64; n=1 | 50.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 4, Baseline; n=20 | 16.4 Units per liter (U/L) | Standard Deviation 8.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 4, Week 40; n=1 | 12.0 Units per liter (U/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 5, Baseline; n=8 | 14.4 Units per liter (U/L) | Standard Deviation 2.97 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT Treatment Course 5, Week 24; n=2 | 11.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 6, Baseline; n=4 | 16.5 Units per liter (U/L) | Standard Deviation 7.19 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 6, Week 16; n=2 | 14.0 Units per liter (U/L) | Standard Deviation 4.24 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT Treatment Course 7, Baseline; n=2 | 14.0 Units per liter (U/L) | Standard Deviation 4.24 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Treatment Course 7, Week 8; n=2 | 14.5 Units per liter (U/L) | Standard Deviation 6.36 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Follow-up Week 12; n=59 | 20.5 Units per liter (U/L) | Standard Deviation 18.17 |
| Ofatumumab 700 mg IV Infusion | Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT) | GGT, Follow-up Week 24; n=18 | 24.8 Units per liter (U/L) | Standard Deviation 36.99 |
Secondary
Assessment of Blood Urea Nitrogen (BUN)
The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to asssess the renal function of the participants.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 3, Week 64; n=1 | 6.80 millimoles per liter | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 4, Baseline; n=20 | 5.75 millimoles per liter | Standard Deviation 1.257 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 1, Baseline; n=92 | 5.85 millimoles per liter | Standard Deviation 1.767 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 1, Week 104; n=1 | 6.40 millimoles per liter | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 2, Baseline; n=73 | 6.10 millimoles per liter | Standard Deviation 1.781 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 2, Week 80; n=1 | 9.60 millimoles per liter | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 3, Baseline; n=53 | 5.78 millimoles per liter | Standard Deviation 1.574 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 4, Week 40; n=1 | 4.60 millimoles per liter | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 5, Baseline; n=8 | 5.49 millimoles per liter | Standard Deviation 1.197 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 5, Week 24; n=2 | 6.05 millimoles per liter | Standard Deviation 0.495 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 6, Baseline; n=4 | 6.95 millimoles per liter | Standard Deviation 1.7 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 6, Week 16; n=2 | 7.15 millimoles per liter | Standard Deviation 0.495 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 7, Baseline; n=2 | 6.60 millimoles per liter | Standard Deviation 0.707 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Treatment Course 7, Week 8; n=2 | 7.15 millimoles per liter | Standard Deviation 1.061 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Follow-up Week 12; n=59 | 5.79 millimoles per liter | Standard Deviation 1.878 |
| Ofatumumab 700 mg IV Infusion | Assessment of Blood Urea Nitrogen (BUN) | Follow-up Week 24; n=18 | 6.04 millimoles per liter | Standard Deviation 2.53 |
Secondary
Assessment of Body Temperature (BT)
The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT.The BT of the participants was measured before BI and PI A and B during all 7 treatment courses.Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.
Time frame: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 5, BI-A, n=8 | 36.40 Degrees celcius | Standard Deviation 0.267 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 5, PI-A, + 2 Hours, n=8 | 36.50 Degrees celcius | Standard Deviation 0.262 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 1, BI-A, n=92 | 36.50 Degrees celcius | Standard Deviation 0.36 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 1, PI-A, + >2 Hours, n=1 | 36.50 Degrees celcius | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 1, BI-B, n=91 | 36.46 Degrees celcius | Standard Deviation 0.368 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 1, PI-B, + 2 Hours, n=48 | 36.53 Degrees celcius | Standard Deviation 0.316 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 2 BI-A, n=73 | 36.48 Degrees celcius | Standard Deviation 0.313 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 2 PI-A, + 2 Hours, n=71 | 36.56 Degrees celcius | Standard Deviation 0.261 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 2 BI-B, n=69 | 36.54 Degrees celcius | Standard Deviation 0.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 2 PI-B, + 2 Hours, n=36 | 36.58 Degrees celcius | Standard Deviation 0.252 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 3 BI-A, n=53 | 36.46 Degrees celcius | Standard Deviation 0.307 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 3 PI-A, + >2 Hours, n=1 | 36.60 Degrees celcius | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 3, BI-B, n=53 | 36.45 Degrees celcius | Standard Deviation 0.392 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 3, PI-B, + 2 Hours, n=26 | 36.59 Degrees celcius | Standard Deviation 0.294 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 4, BI-A, n=20 | 36.50 Degrees celcius | Standard Deviation 0.381 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 4, PI-A, + 2 Hours, n=19 | 36.58 Degrees celcius | Standard Deviation 0.242 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 4, BI-B, n=19 | 36.53 Degrees celcius | Standard Deviation 0.421 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 4, PI-B, + 2 Hours, n=2 | 37.00 Degrees celcius | Standard Deviation 0.283 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 5, BI-B, n=8 | 36.41 Degrees celcius | Standard Deviation 0.242 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 5, PI-B, + 1 Hour, n=7 | 36.49 Degrees celcius | Standard Deviation 0.329 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 6, BI-A, n=4 | 36.48 Degrees celcius | Standard Deviation 0.126 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 6, PI-A, + 2 Hours, n=4 | 36.48 Degrees celcius | Standard Deviation 0.25 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 6, BI-B, n=4 | 36.35 Degrees celcius | Standard Deviation 0.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 6, PI-B, + 1 Hour, n=4 | 36.45 Degrees celcius | Standard Deviation 0.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 7, BI-A, n=2 | 36.55 Degrees celcius | Standard Deviation 0.071 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 7, PI-A, + 2 Hours, n=1 | 36.60 Degrees celcius | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 7, BI-B, n=2 | 36.65 Degrees celcius | Standard Deviation 0.071 |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Treatment Course 7, PI-B, + 2 Hours, n=1 | 36.60 Degrees celcius | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Body Temperature (BT) | BT, Follow-up, n=78 | 36.57 Degrees celcius | Standard Deviation 0.323 |
Secondary
Assessment of Heart Rate (HR)
The HR of the participants was measured to assess the condition of the heart.HR was measured BI and post the first (A) and second (B) infusins during all 7 treatment courses.Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.
Time frame: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 1, BI-A, n=92 | 73.4 Beats per minute (bpm) | Standard Deviation 10.1 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 1, PI-A, + >2 Hours, n=2 | 76.5 Beats per minute (bpm) | Standard Deviation 12.02 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 1, BI-B, n=91 | 71.8 Beats per minute (bpm) | Standard Deviation 9.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 1, PI-B, + 2 Hours, n=48 | 74.9 Beats per minute (bpm) | Standard Deviation 10.72 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 2, BI-A, n=73 | 70.9 Beats per minute (bpm) | Standard Deviation 7.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 2, PI-A, + 2 Hours, n=71 | 74.3 Beats per minute (bpm) | Standard Deviation 7.88 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 2, BI-B, n=69 | 72.9 Beats per minute (bpm) | Standard Deviation 8.02 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 2, PI-B, + 2 Hours, n=36 | 73.4 Beats per minute (bpm) | Standard Deviation 7.53 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 3, BI-A, n=53 | 72.6 Beats per minute (bpm) | Standard Deviation 6.99 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 3, PI-A, + >2 Hours, n= 1 | 68.0 Beats per minute (bpm) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 3, BI-B, n=53 | 72.2 Beats per minute (bpm) | Standard Deviation 8.57 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 3, PI-B, + 2 Hours, n=26 | 75.6 Beats per minute (bpm) | Standard Deviation 6.11 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 4, BI-A, n=20 | 70.8 Beats per minute (bpm) | Standard Deviation 5.77 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 4, PI-A, + 2 Hours, n=19 | 74.6 Beats per minute (bpm) | Standard Deviation 6.5 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 4, BI-B, n=19 | 70.5 Beats per minute (bpm) | Standard Deviation 4.43 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 4, PI-B, + 2 Hours, n=2 | 76.0 Beats per minute (bpm) | Standard Deviation 5.66 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 5, BI-A, n=8 | 70.9 Beats per minute (bpm) | Standard Deviation 3 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 5, PI-A, + 2 Hours, n=8 | 72.6 Beats per minute (bpm) | Standard Deviation 3.66 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 5, BI-B, n=8 | 68.9 Beats per minute (bpm) | Standard Deviation 4.58 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 5, PI-B, + 1 Hour, n=7 | 71.7 Beats per minute (bpm) | Standard Deviation 4.96 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 6, BI-A, n=4 | 70.0 Beats per minute (bpm) | Standard Deviation 4 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 6, PI-A, + 2 Hours, n=4 | 71.0 Beats per minute (bpm) | Standard Deviation 6 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 6, BI-B, n=4 | 68.0 Beats per minute (bpm) | Standard Deviation 5.66 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 6, PI-B, + 1 Hour, n=4 | 72.0 Beats per minute (bpm) | Standard Deviation 0 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 7, BI-A, n=2 | 72.0 Beats per minute (bpm) | Standard Deviation 0 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 7, PI-A, + 2 Hours, n=1 | 72.0 Beats per minute (bpm) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 7, BI-B, n=2 | 70.0 Beats per minute (bpm) | Standard Deviation 2.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Treatment Course 7, PI-B, + 2 Hours, n=1 | 68.0 Beats per minute (bpm) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Heart Rate (HR) | HR, Follow-up, n=78 | 72.1 Beats per minute (bpm) | Standard Deviation 8.05 |
Secondary
Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK)
Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis.
Time frame: 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 6, Baseline, n=4 | 84.8 U/L | Standard Deviation 23.91 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 6, Week 16, n=2 | 100.0 U/L | Standard Deviation 14.14 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 7, Baseline, n=2 | 103.0 U/L | Standard Deviation 19.8 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 1, Baseline, n=92 | 189.6 U/L | Standard Deviation 35.18 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 1, Week 104, n=1 | 229.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 2, Baseline, n=73 | 198.6 U/L | Standard Deviation 77.62 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 2, Week 80, n=1 | 219.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 3, Baseline, n=53 | 186.5 U/L | Standard Deviation 37.39 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 3, Week 64, n=1 | 242.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 4, Baseline, n=20 | 184.6 U/L | Standard Deviation 35.52 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 4, Week 40, n=1 | 170.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 5, Baseline, n=8 | 179.4 U/L | Standard Deviation 25.03 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 5, Week 24, n=2 | 168.5 U/L | Standard Deviation 27.58 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 6, Baseline, n=4 | 173.3 U/L | Standard Deviation 15.13 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 6, Week 16, n=2 | 234.0 U/L | Standard Deviation 53.74 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 7, Baseline, n=2 | 292.0 U/L | Standard Deviation 140.01 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | LDH, Treatment Course 7, Week 8, n=2 | 190.0 U/L | Standard Deviation 25.46 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 1, Baseline, n=92 | 61.4 U/L | Standard Deviation 29.25 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 1, Week 104, n=1 | 127.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 2, Baseline, n=73 | 70.5 U/L | Standard Deviation 31.07 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 2, Week 80, n=1 | 61.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 3, Baseline, n=53 | 77.7 U/L | Standard Deviation 50.86 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 3, Week 64, n=1 | 81.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 4, Baseline n=20 | 85.4 U/L | Standard Deviation 64.46 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 4, Week 40, n=1 | 52.0 U/L | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 5, Baseline, n=8 | 157.6 U/L | Standard Deviation 216.71 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 5, Week 24, n=2 | 82.5 U/L | Standard Deviation 27.58 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Treatment Course 7, Week 8, n=2 | 109.0 U/L | Standard Deviation 15.56 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Follow-up Week 12, n=59 | 79.3 U/L | Standard Deviation 38.73 |
| Ofatumumab 700 mg IV Infusion | Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK) | CPK, Follow-up Week 24, n=18 | 77.0 U/L | Standard Deviation 26.09 |
Secondary
Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid
Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 1, Week 104; n=1 | 144.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 2, Baseline; n=73 | 142.3 Millimoles/liter (mmol/L) | Standard Deviation 2.25 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 2, Week 80; n=1 | 145.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 3, Baseline; n=53 | 143.3 Millimoles/liter (mmol/L) | Standard Deviation 2.26 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 3, Week 64; n=1 | 147.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 4, Baseline; n=20 | 142.8 Millimoles/liter (mmol/L) | Standard Deviation 2.65 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 4, Week 40; n=1 | 145.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 5, Baseline; n=8 | 143.1 Millimoles/liter (mmol/L) | Standard Deviation 2.3 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 5, Week 24; n=2 | 142.5 Millimoles/liter (mmol/L) | Standard Deviation 2.12 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 6, Baseline; n=4 | 142.0 Millimoles/liter (mmol/L) | Standard Deviation 1.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 6, Week 16; n=2 | 141.5 Millimoles/liter (mmol/L) | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 7, Baseline; n=2 | 142.5 Millimoles/liter (mmol/L) | Standard Deviation 0.71 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 7, Week 8; n=2 | 141.0 Millimoles/liter (mmol/L) | Standard Deviation 2.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 1, Baseline; n=92 | 4.25 Millimoles/liter (mmol/L) | Standard Deviation 0.317 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 1, Week 104; n=1 | 3.30 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 2, Baseline; n=73 | 4.32 Millimoles/liter (mmol/L) | Standard Deviation 0.386 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 2, Week 80; n=1 | 4.20 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 3, Baseline; n=53 | 4.25 Millimoles/liter (mmol/L) | Standard Deviation 0.358 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 3, Week 64; n=1 | 4.60 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 4, Baseline; n=20 | 4.20 Millimoles/liter (mmol/L) | Standard Deviation 0.208 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 4, Week 40; n=1 | 4.20 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 5, Baseline; n=8 | 4.34 Millimoles/liter (mmol/L) | Standard Deviation 0.22 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 5, Week 24; n=2 | 4.40 Millimoles/liter (mmol/L) | Standard Deviation 0.283 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 6, Baseline; n=4 | 4.48 Millimoles/liter (mmol/L) | Standard Deviation 0.377 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 6, Week 16; n=2 | 4.45 Millimoles/liter (mmol/L) | Standard Deviation 0.495 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 7, Baseline; n=2 | 4.50 Millimoles/liter (mmol/L) | Standard Deviation 0.707 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Potassium, Treatment Course 7, Week 8; n=2 | 4.35 Millimoles/liter (mmol/L) | Standard Deviation 0.495 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 1, Baseline; n=92 | 105.2 Millimoles/liter (mmol/L) | Standard Deviation 2.98 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 1, Week 104; n=1 | 104.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride Treatment Course 2, Baseline; n=73 | 105.6 Millimoles/liter (mmol/L) | Standard Deviation 2.18 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride Treatment Course 2, Week 80; n=1 | 105.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 3, Baseline; n=53 | 106.0 Millimoles/liter (mmol/L) | Standard Deviation 2.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 3, Week 64; n=1 | 111.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride Treatment Course 4, Baseline; n=20 | 105.9 Millimoles/liter (mmol/L) | Standard Deviation 3.56 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 4, Week 40; n=1 | 102.0 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride Treatment Course 5, Baseline; n=8 | 104.8 Millimoles/liter (mmol/L) | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 5, Week 24; n=2 | 105.5 Millimoles/liter (mmol/L) | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 6, Baseline; n=4 | 105.0 Millimoles/liter (mmol/L) | Standard Deviation 3.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 6, Week 16; n=2 | 105.0 Millimoles/liter (mmol/L) | Standard Deviation 2.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 7, Baseline; n=2 | 104.0 Millimoles/liter (mmol/L) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Chloride, Treatment Course 7, Week 8; n=2 | 105.0 Millimoles/liter (mmol/L) | Standard Deviation 4.24 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 1, Baseline; n=92 | 24.67 Millimoles/liter (mmol/L) | Standard Deviation 2.519 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 1, Week 104; n=1 | 28.40 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 2, Baseline; n=73 | 25.10 Millimoles/liter (mmol/L) | Standard Deviation 2.416 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 2, Week 80; n=1 | 22.80 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 3, Baseline; n=53 | 25.49 Millimoles/liter (mmol/L) | Standard Deviation 2.299 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 3, Week 64; n=1 | 25.40 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 4, Baseline; n=20 | 24.61 Millimoles/liter (mmol/L) | Standard Deviation 2.748 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 4, Week 40; n=1 | 30.00 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 5, Baseline; n=8 | 26.20 Millimoles/liter (mmol/L) | Standard Deviation 2.262 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 5, Week 24; n=2 | 27.20 Millimoles/liter (mmol/L) | Standard Deviation 4.243 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, , Treatment Course 6, Baseline; n=4 | 25.00 Millimoles/liter (mmol/L) | Standard Deviation 0.876 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 6, Week 16; n=2 | 24.50 Millimoles/liter (mmol/L) | Standard Deviation 2.546 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 7, Baseline; n=2 | 24.80 Millimoles/liter (mmol/L) | Standard Deviation 1.414 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Bicarbonate, Treatment Course 7, Week 8; n=2 | 23.40 Millimoles/liter (mmol/L) | Standard Deviation 0.849 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 1, Baseline; n=92 | 2.324 Millimoles/liter (mmol/L) | Standard Deviation 0.0965 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium Treatment Course 1, Week 104; n=1 | 2.250 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 2, Baseline; n=73 | 2.305 Millimoles/liter (mmol/L) | Standard Deviation 0.0991 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 2, Week 80; n=1 | 2.200 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 3, Baseline; n=53 | 2.312 Millimoles/liter (mmol/L) | Standard Deviation 0.0935 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 3, Week 64; n=1 | 2.300 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 4, Baseline; n=20 | 2.315 Millimoles/liter (mmol/L) | Standard Deviation 0.1113 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 4, Week 40; n=1 | 2.400 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 5, Baseline; n=8 | 2.313 Millimoles/liter (mmol/L) | Standard Deviation 0.0954 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 5, Week 24; n=2 | 2.275 Millimoles/liter (mmol/L) | Standard Deviation 0.1061 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 6, Baseline; n=4 | 2.338 Millimoles/liter (mmol/L) | Standard Deviation 0.1109 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 6, Week 16; n=2 | 2.275 Millimoles/liter (mmol/L) | Standard Deviation 0.1061 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 7, Baseline; n=2 | 2.375 Millimoles/liter (mmol/L) | Standard Deviation 0.1768 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Calcium, Treatment Course 7, Week 8; n=2 | 2.300 Millimoles/liter (mmol/L) | Standard Deviation 0.0707 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 1, Baseline; n=92 | 0.259 Millimoles/liter (mmol/L) | Standard Deviation 0.0684 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 1, Week 104; n=1 | 0.380 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 2, Baseline; n=73 | 0.265 Millimoles/liter (mmol/L) | Standard Deviation 0.0572 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 2, Week 80; n=1 | 0.300 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 3, Baseline; n=53 | 0.259 Millimoles/liter (mmol/L) | Standard Deviation 0.0502 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 3, Week 64; n=1 | 0.250 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 4, Baseline; n=20 | 0.256 Millimoles/liter (mmol/L) | Standard Deviation 0.0518 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 4, Week 40; n=1 | 0.310 Millimoles/liter (mmol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 5, Baseline; n=8 | 0.275 Millimoles/liter (mmol/L) | Standard Deviation 0.0407 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 5, Week 24; n=2 | 0.245 Millimoles/liter (mmol/L) | Standard Deviation 0.0354 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 6, Baseline; n=4 | 0.273 Millimoles/liter (mmol/L) | Standard Deviation 0.0222 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 6, Week 16; n=2 | 0.265 Millimoles/liter (mmol/L) | Standard Deviation 0.0212 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 7, Baseline; n=2 | 0.250 Millimoles/liter (mmol/L) | Standard Deviation 0.0424 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Uric acid, Treatment Course 7, Week 8; n=2 | 0.295 Millimoles/liter (mmol/L) | Standard Deviation 0.0354 |
| Ofatumumab 700 mg IV Infusion | Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid | Sodium, Treatment Course 1, Baseline; n=92 | 142.1 Millimoles/liter (mmol/L) | Standard Deviation 2.76 |
Secondary
Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses.Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.
Time frame: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 1, BI-A, n =92 | 121.7 Millimeters of mercury (mmHg) | Standard Deviation 18.2 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 1, PI-A, + >2 Hours, n=2 | 138.5 Millimeters of mercury (mmHg) | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 1, BI-B, n=91 | 119.9 Millimeters of mercury (mmHg) | Standard Deviation 18.38 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 1, PI-B, + 2 Hours, n=48 | 122.8 Millimeters of mercury (mmHg) | Standard Deviation 13.22 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 2, BI-A, n=73 | 117.3 Millimeters of mercury (mmHg) | Standard Deviation 16.84 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 2, PI-A, + 2 Hours, n=71 | 121.4 Millimeters of mercury (mmHg) | Standard Deviation 13.86 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 2, BI-B, n=69 | 116.8 Millimeters of mercury (mmHg) | Standard Deviation 16.09 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 2, PI-B, + 2 Hours, n=36 | 120.5 Millimeters of mercury (mmHg) | Standard Deviation 13.52 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 3, BI-A, n=53 | 116.8 Millimeters of mercury (mmHg) | Standard Deviation 15.61 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 3, PI-A, + >2 Hours, n=1 | 125.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 3, BI-B, n=53 | 120.1 Millimeters of mercury (mmHg) | Standard Deviation 15.59 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 3, PI-B, + 2 Hours, n=26 | 121.2 Millimeters of mercury (mmHg) | Standard Deviation 9.63 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 4, BI-A, n=20 | 114.2 Millimeters of mercury (mmHg) | Standard Deviation 14.86 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 4, PI-A, + 2 Hours, n=19 | 116.0 Millimeters of mercury (mmHg) | Standard Deviation 12.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 4, BI-B, n=19 | 111.8 Millimeters of mercury (mmHg) | Standard Deviation 14.86 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 4, PI-B, + 2 Hours, n=2 | 115.0 Millimeters of mercury (mmHg) | Standard Deviation 15.56 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 5, BI-A, n=8 | 116.1 Millimeters of mercury (mmHg) | Standard Deviation 16.17 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 5, PI-A, + 2 Hours, n=8 | 114.0 Millimeters of mercury (mmHg) | Standard Deviation 11.99 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 5, BI-B, n=8 | 102.5 Millimeters of mercury (mmHg) | Standard Deviation 12.54 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 5, PI-B, + 1 Hour, n=7 | 103.6 Millimeters of mercury (mmHg) | Standard Deviation 14.35 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 6, BI-A, n=4 | 123.8 Millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 6, PI-A, + 2 Hours, n=4 | 117.5 Millimeters of mercury (mmHg) | Standard Deviation 12.58 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 6, BI-B, n=4 | 118.8 Millimeters of mercury (mmHg) | Standard Deviation 13.15 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 6, PI-B, + 1 Hour, n=4 | 127.5 Millimeters of mercury (mmHg) | Standard Deviation 2.89 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 7, BI-A, n=2 | 120.0 Millimeters of mercury (mmHg) | Standard Deviation 14.14 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 7, PI-A, + 2 Hours, n=1 | 125.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 7, BI-B, n=2 | 110.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Treatment Course 7, PI-B, + 2 Hours, n=1 | 125.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 1, BI-A, n=92 | 76.3 Millimeters of mercury (mmHg) | Standard Deviation 11.51 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 1, PI-A, +>2 Hours, n=90 | 86.5 Millimeters of mercury (mmHg) | Standard Deviation 6.36 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 1, BI-B, n=91 | 74.4 Millimeters of mercury (mmHg) | Standard Deviation 11.85 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 1, PI-B, + 2 Hours, n=48 | 75.5 Millimeters of mercury (mmHg) | Standard Deviation 8.73 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 2, BI-A, n=73 | 73.4 Millimeters of mercury (mmHg) | Standard Deviation 10.26 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 2, PI-A, + 2 Hours, n=71 | 74.8 Millimeters of mercury (mmHg) | Standard Deviation 8.56 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 2, BI-B, n=69 | 72.8 Millimeters of mercury (mmHg) | Standard Deviation 10.37 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 2, PI-B, + 2 Hours, n=36 | 74.0 Millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 3, BI-A, n=53 | 72.1 Millimeters of mercury (mmHg) | Standard Deviation 10.84 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 3, PI-A, >2 Hours, n=1 | 75.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 3, BI-B, n=53 | 74.7 Millimeters of mercury (mmHg) | Standard Deviation 10.53 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 3, PI-B, + 2 Hours, n=26 | 75.3 Millimeters of mercury (mmHg) | Standard Deviation 8.02 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 4, BI-A, n=20 | 71.7 Millimeters of mercury (mmHg) | Standard Deviation 11.59 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 4, PI-A, + 2 Hours, n=19 | 75.1 Millimeters of mercury (mmHg) | Standard Deviation 9.79 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 4, BI-B, n=19 | 71.7 Millimeters of mercury (mmHg) | Standard Deviation 10.87 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 4, PI-B, + 2 Hours, n=2 | 75.0 Millimeters of mercury (mmHg) | Standard Deviation 7.07 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 5, BI-A, n=8 | 74.6 Millimeters of mercury (mmHg) | Standard Deviation 12.06 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 5, PI-A, + 2 Hours, n=8 | 77.5 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 5, BI-B, n=8 | 68.4 Millimeters of mercury (mmHg) | Standard Deviation 6.74 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 5, PI-B, +1 Hour, n=7 | 69.7 Millimeters of mercury (mmHg) | Standard Deviation 10.44 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 6, BI-A, n=4 | 77.5 Millimeters of mercury (mmHg) | Standard Deviation 6.45 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 6, PI-A, + 2 Hours, n=4 | 78.8 Millimeters of mercury (mmHg) | Standard Deviation 4.79 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 6, BI-B, n=4 | 68.8 Millimeters of mercury (mmHg) | Standard Deviation 10.31 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 6, PI-B, 1 Hour, n=4 | 81.3 Millimeters of mercury (mmHg) | Standard Deviation 2.5 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 7, BI-A, n=2 | 85.0 Millimeters of mercury (mmHg) | Standard Deviation 7.07 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 7, PI-A, + 2 Hours, n=1 | 90.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 7, BI-B, n=2 | 75.0 Millimeters of mercury (mmHg) | Standard Deviation 7.07 |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Treatment Course 7, PI-B, + 2 Hours, n=1 | 90.0 Millimeters of mercury (mmHg) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Follow-up, n=78 | 76.9 Millimeters of mercury (mmHg) | Standard Deviation 9.16 |
Secondary
Assessment of Total Bilirubin (TB) and Creatinine
Blood samples of participants were collected to evaluatate TB and creatinine levles. TB evlauation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaulation is performed to assess the renal condition (condition of the kidneys).
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 1, Baseline; n=92 | 7.18 Micromoles per liter (umol/L) | Standard Deviation 3.823 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 1, Week 104; n=1 | 6.30 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 2, Baseline; n=73 | 7.91 Micromoles per liter (umol/L) | Standard Deviation 4.528 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 2, Week 80; n=1 | 3.10 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 3, Baseline; n=53 | 7.84 Micromoles per liter (umol/L) | Standard Deviation 4.501 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 3, Week 64; n=1 | 8.00 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 4, Baseline; n=20 | 7.68 Micromoles per liter (umol/L) | Standard Deviation 3.652 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 4, Week 40; n=1 | 7.50 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 5, Baseline; n=8 | 9.20 Micromoles per liter (umol/L) | Standard Deviation 5.283 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 5, Week 24; n=2 | 6.40 Micromoles per liter (umol/L) | Standard Deviation 2.546 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 6, Baseline; n=4 | 10.38 Micromoles per liter (umol/L) | Standard Deviation 3.779 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 6, Week 16; n=2 | 9.85 Micromoles per liter (umol/L) | Standard Deviation 0.636 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 7, Baseline; n=2 | 8.95 Micromoles per liter (umol/L) | Standard Deviation 1.344 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | TB, Treatment Course 7, Week 8; n=2 | 14.05 Micromoles per liter (umol/L) | Standard Deviation 5.586 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 1, Baseline; n=92 | 64.14 Micromoles per liter (umol/L) | Standard Deviation 12.569 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 1, Week 104; n=1 | 54.80 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 2, Baseline; n=73 | 67.82 Micromoles per liter (umol/L) | Standard Deviation 14.735 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 2, Week 80; n=1 | 75.10 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 3, Baseline; n=53 | 65.50 Micromoles per liter (umol/L) | Standard Deviation 10.871 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 3, Week 64; n=1 | 68.10 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 4, Baseline; n=20 | 65.36 Micromoles per liter (umol/L) | Standard Deviation 12.626 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 4, Week 40; n=1 | 70.70 Micromoles per liter (umol/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 5, Baseline; n=8 | 67.75 Micromoles per liter (umol/L) | Standard Deviation 7.543 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 5, Week 24; n=2 | 64.55 Micromoles per liter (umol/L) | Standard Deviation 6.293 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 6, Baseline; n=4 | 67.63 Micromoles per liter (umol/L) | Standard Deviation 11.909 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 6, Week 16; n=2 | 60.55 Micromoles per liter (umol/L) | Standard Deviation 8.132 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 7, Baseline; n=2 | 61.40 Micromoles per liter (umol/L) | Standard Deviation 13.111 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Treatment Course 7, Week 8; n=2 | 59.65 Micromoles per liter (umol/L) | Standard Deviation 9.405 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Follow-up Week 12; n=59 | 69.72 Micromoles per liter (umol/L) | Standard Deviation 15.553 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Bilirubin (TB) and Creatinine | Creatinine, Follow-up Week 24; n=18 | 74.95 Micromoles per liter (umol/L) | Standard Deviation 21.833 |
Secondary
Assessment of Total Protein (TP) and Albumin
Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 1, Baseline; n=92 | 76.3 Grams/Liter (g/L) | Standard Deviation 4.97 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 1, Week 104; n=1 | 72.0 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 2, Baseline; n=73 | 76.2 Grams/Liter (g/L) | Standard Deviation 4.53 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 2, Week 80; n=1 | 72.0 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 3, Baseline; n=53 | 74.7 Grams/Liter (g/L) | Standard Deviation 4.8 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 3, Week 64; n=1 | 71.0 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 4, Baseline; n=20 | 73.9 Grams/Liter (g/L) | Standard Deviation 5.44 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 4, Week 40; n=1 | 78.0 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 5, Baseline; n=8 | 75.6 Grams/Liter (g/L) | Standard Deviation 4.17 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 5, Week 24; n=2 | 75.0 Grams/Liter (g/L) | Standard Deviation 5.66 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 6, Baseline; n=4 | 74.8 Grams/Liter (g/L) | Standard Deviation 4.5 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 6, Week 16; n=2 | 77.0 Grams/Liter (g/L) | Standard Deviation 5.66 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 7, Baseline; n=2 | 78.5 Grams/Liter (g/L) | Standard Deviation 6.36 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | TP, Treatment Course 7, Week 8; n=2 | 75.0 Grams/Liter (g/L) | Standard Deviation 2.83 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 1, Baseline; n=92 | 43.50 Grams/Liter (g/L) | Standard Deviation 3.043 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 1, Week 104; n=1 | 40.80 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 2, Baseline; n=73 | 44.21 Grams/Liter (g/L) | Standard Deviation 2.984 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 2, Week 80; n=1 | 39.10 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 3, Baseline; n=53 | 44.18 Grams/Liter (g/L) | Standard Deviation 3.332 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 3, Week 64; n=1 | 43.40 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 4, Baseline; n=20 | 44.34 Grams/Liter (g/L) | Standard Deviation 3.497 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 4, Week 40; n=1 | 46.20 Grams/Liter (g/L) | — |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 5, Baseline; n=8 | 46.75 Grams/Liter (g/L) | Standard Deviation 3.203 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 5, Week 24; n=2 | 45.90 Grams/Liter (g/L) | Standard Deviation 2.263 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 6, Baseline; n=4 | 45.83 Grams/Liter (g/L) | Standard Deviation 3.035 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 6, Week 16; n=2 | 46.80 Grams/Liter (g/L) | Standard Deviation 2.546 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 7, Baseline; n=2 | 48.00 Grams/Liter (g/L) | Standard Deviation 3.536 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Treatment Course 7, Week 8; n=2 | 45.75 Grams/Liter (g/L) | Standard Deviation 1.344 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Follow-up Week 12; n=59 | 43.93 Grams/Liter (g/L) | Standard Deviation 3.002 |
| Ofatumumab 700 mg IV Infusion | Assessment of Total Protein (TP) and Albumin | Albumin, Follow-up Week 24; n=18 | 44.66 Grams/Liter (g/L) | Standard Deviation 3.642 |
Secondary
CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3
Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 2, Baseline; n=71 | 30.0 cells per millimeters cubed (mm^3) | Standard Deviation 49.36 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 3, Baseline; n=51 | 43.8 cells per millimeters cubed (mm^3) | Standard Deviation 50.11 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 4, Week 40; n=1 | 54.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 7, Baseline; n=2 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 7, Week 8; n=2 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 1, Baseline; n=92 | 1325.3 cells per millimeters cubed (mm^3) | Standard Deviation 467.4 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 1, Week 104; n=1 | 2174.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 2, Baseline; n=71 | 1338.8 cells per millimeters cubed (mm^3) | Standard Deviation 557.04 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 2, Week 80; n=1 | 1051.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 3, Baseline; n=51 | 1325.1 cells per millimeters cubed (mm^3) | Standard Deviation 398.74 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 3, Week 64; n=1 | 1213.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 1, Baseline; n=92 | 869.2 cells per millimeters cubed (mm^3) | Standard Deviation 386.45 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 1, Week 104; n=1 | 1544.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 2, Baseline; n=71 | 877.3 cells per millimeters cubed (mm^3) | Standard Deviation 443.09 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 2, Week 80; n=1 | 715.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 6, Week 12; n=4 | 919.8 cells per millimeters cubed (mm^3) | Standard Deviation 380.08 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 7, Baseline; n=2 | 686.0 cells per millimeters cubed (mm^3) | Standard Deviation 1.41 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 7, Week 8; n=2 | 755.5 cells per millimeters cubed (mm^3) | Standard Deviation 30.41 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 1, Baseline; n=92 | 387.7 cells per millimeters cubed (mm^3) | Standard Deviation 183.18 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 2, Baseline; n=71 | 391.0 cells per millimeters cubed (mm^3) | Standard Deviation 193.89 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 2, Week 80; n=1 | 315.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 3, Baseline; n=51 | 383.3 cells per millimeters cubed (mm^3) | Standard Deviation 159.28 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 3, Week 64; n=1 | 279.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 4, Baseline; n=20 | 389.0 cells per millimeters cubed (mm^3) | Standard Deviation 151.22 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 4, Week 40; n=1 | 398.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 5, Baseline; n=8 | 411.0 cells per millimeters cubed (mm^3) | Standard Deviation 198.41 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 5, Week 24; n=2 | 338.5 cells per millimeters cubed (mm^3) | Standard Deviation 202.94 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 6, Baseline; n=4 | 502.3 cells per millimeters cubed (mm^3) | Standard Deviation 234.8 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 6, Week 12; n=4 | 443.8 cells per millimeters cubed (mm^3) | Standard Deviation 298.72 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 7, Baseline; n=2 | 327.0 cells per millimeters cubed (mm^3) | Standard Deviation 155.56 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 1, Baseline; n=92 | 109.6 cells per millimeters cubed (mm^3) | Standard Deviation 91.12 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 1, Week 104; n=1 | 95.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 2, Week 80; n=1 | 24.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 3, Week 64; n=1 | 16.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 4, Baseline; n=20 | 27.2 cells per millimeters cubed (mm^3) | Standard Deviation 43.75 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 5, Baseline; n=8 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 5, Week 24; n=2 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 6, Baseline; n=4 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD19+, Treatment Course 6, Week 12; n=4 | 0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 4, Baseline; n=20 | 1388.3 cells per millimeters cubed (mm^3) | Standard Deviation 502.8 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 4, Week 40; n=1 | 1594.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 5, Baseline; n=8 | 1324.1 cells per millimeters cubed (mm^3) | Standard Deviation 618.65 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 5, Week 24; n=2 | 1218.5 cells per millimeters cubed (mm^3) | Standard Deviation 342.95 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 6, Baseline; n=4 | 1574.3 cells per millimeters cubed (mm^3) | Standard Deviation 553.71 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 6, Week 12; n=4 | 1430.8 cells per millimeters cubed (mm^3) | Standard Deviation 507.31 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 7, Baseline; n=2 | 1062.0 cells per millimeters cubed (mm^3) | Standard Deviation 169.71 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD3+, Treatment Course 7, Week 8; n=2 | 1230.0 cells per millimeters cubed (mm^3) | Standard Deviation 373.35 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 3, Baseline; n=51 | 876.7 cells per millimeters cubed (mm^3) | Standard Deviation 310.96 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 3, Week 64; n=1 | 910.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 4, Baseline; n=20 | 931.8 cells per millimeters cubed (mm^3) | Standard Deviation 451.3 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 4, Week 40; n=1 | 1116.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 5, Baseline; n=8 | 837.3 cells per millimeters cubed (mm^3) | Standard Deviation 499.45 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 5, Week 24; n=2 | 729.0 cells per millimeters cubed (mm^3) | Standard Deviation 18.38 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD4+, Treatment Course 6, Baseline; n=4 | 1000.3 cells per millimeters cubed (mm^3) | Standard Deviation 545.33 |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 1, Week 104; n=1 | 543.0 cells per millimeters cubed (mm^3) | — |
| Ofatumumab 700 mg IV Infusion | CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3 | CD8+, Treatment Course 7, Week 8; n=2 | 400.0 cells per millimeters cubed (mm^3) | Standard Deviation 278.6 |
Secondary
Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)
DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.
Time frame: Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. One participant withdrew during the first infusion due to AEs of rash and pruritis. Only participants available at the indicated time point were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 2, n=71 | -1.32 scores on a scale | Standard Deviation 0.771 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 7, n=2 | -2.14 scores on a scale | Standard Deviation 1.893 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 1, n=91 | -1.79 scores on a scale | Standard Deviation 0.906 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 3, n=53 | -1.27 scores on a scale | Standard Deviation 0.793 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 4, n=20 | -1.55 scores on a scale | Standard Deviation 0.97 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 5, n=8 | -1.88 scores on a scale | Standard Deviation 1.181 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP) | Treatment Course 6, n=4 | -0.88 scores on a scale | Standard Deviation 0.572 |
Secondary
Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)
DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.
Time frame: Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. One participant withdrew during the first infusion due to adverse events (AEs) of rash and pruritus. Only participants available at the indicated time point were assessed. Minimum change from baseline is defined as the smallest change at any visit over the course of Weeks 1 to 24 of each treatment cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 2, n=71 | -1.58 scores on a scale | Standard Deviation 0.824 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 3, n=53 | -1.52 scores on a scale | Standard Deviation 0.849 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 4, n=20 | -1.65 scores on a scale | Standard Deviation 1.11 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 7, n=2 | -2.10 scores on a scale | Standard Deviation 2.146 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 1, n=91 | -1.92 scores on a scale | Standard Deviation 0.918 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 5, n=8 | -2.16 scores on a scale | Standard Deviation 1.114 |
| Ofatumumab 700 mg IV Infusion | Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour) | Treatment Course 6, n=4 | -0.87 scores on a scale | Standard Deviation 0.771 |
Secondary
Number of Participants Achieving ACR50
ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants Achieving ACR70
ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants Achieving American College of Rheumatology (ACR)20
ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ)
The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter
Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 2, Baseline; n=73 | 66 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 2, Week 80; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 3, Baseline; n=53 | 48 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 3, Week 64; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 3, At any time; n=53 | 48 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 4, Baseline; n=20 | 15 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 4, Week 40; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 4, At any time; n=20 | 15 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 5, Baseline; n=8 | 7 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 5, Week 24; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 5, At any time; n=8 | 7 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 6, Baseline; n=4 | 3 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 6, Week 16; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 6, At any time; n=4 | 3 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 7, Baseline; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 1, Baseline; n=92 | 80 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 1, Week 104; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 1, At any time; n=92 | 83 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 2, At any time; n=73 | 67 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 7, Week 8; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter | Treatment Course 7, At any time; n=2 | 1 participants |
Secondary
Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter
Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in automimmune diseases. It regulates the immunnoglobin (antibody produced by B cells that is used by the immune system to indentify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 1, Baseline; n=92 | 12 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 1, Week 104; n=1 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 2, Baseline; n=73 | 38 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 2, Week 80; n=1 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 2, At any time; n=73 | 65 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 3, Baseline; n=53 | 32 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 3, Week 64; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 3, At any time; n=53 | 48 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 4, Baseline; n=20 | 12 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 1, At any time; n=92 | 81 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 4, Week 40; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 4, At any time; n=20 | 16 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 5, Baseline; n=8 | 7 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 5, Week 24; n=2 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 5, At any time; n=8 | 7 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 6, Baseline; n=4 | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 6, Week 16; n=2 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 6, At any time; n=4 | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 7, Baseline; n=2 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 7, Week 8; n=2 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter | Treatment Course 7, At any time; n=2 | 2 participants |
Secondary
Number of Participants With HAHA Response
The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter
Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 1, Baseline; n=92 | 40 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 1, Week 104; n=1 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 1, At any time; n=92 | 47 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 2, Baseline; n=73 | 12 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 2, Week 80; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 2, At any time; n=73 | 27 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 3, Baseline; n=52 | 11 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 3, Week 64; n=1 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 3, At any time; n=53 | 15 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 4, Baseline; n=20 | 3 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 4, Week 40; n=1 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 4, At any time; n=20 | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 5, Baseline; n=8 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 5, Week 24; n=2 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 5, At any time; n=8 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 6, Baseline; n=4 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 6, Week 16; n=2 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 6, At any time; n=4 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 7, Baseline; n=2 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 7, Week 8; n=2 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter | Treatment Course 7, At any time; n=2 | 0 participants |
Secondary
Number of Participants With Normal and Abnormal Electrocardiogram Readings
Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded.
Time frame: 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 24, Normal | 64 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 24, Abnormal NCS | 9 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 24, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 104, Normal | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 104, Abnormal NCS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 1, Week 104, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 24, Normal | 43 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 24, Abnormal NCS | 17 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 24, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 80, Normal | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 80, Abnormal NCS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 2, Week 80, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 3, Week 24, Normal | 24 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 3, Week 24, Abnormal NCS | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 3, Week 56, Normal | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 3, Week 56, Abnormal NCS | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 3, Week 56, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 24, Normal | 7 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 24, Abnormal NCS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 24, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 32, Normal | 3 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 32, Abnormal NCS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 4, Week 32, Abnormal CS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 5, Week 24, Normal | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 5, Week 24, Abnormal NCS | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Normal and Abnormal Electrocardiogram Readings | Treatment Course 5, Week 24, Abnormal CS | 0 participants |
Secondary
Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter
Blood samples of participants were collected for the evaulation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 1, Baseline; n=92 | 79 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 1, Week 104; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 1, At any time; n=92 | 81 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 2, Baseline; n=73 | 60 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 2, Week 80; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 2, At any time; n=73 | 63 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 3, Baseline; n=53 | 42 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 3, Week 64; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 3, At any time; n=53 | 46 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 4, Baseline; n=20 | 13 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 4, Week 40; n=1 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 4, At any time; n=20 | 14 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 5, Baseline; n=8 | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 5, Week 24; n=2 | 0 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 5, At any time; n=8 | 4 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 6, Baseline; n=4 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 6, Week 16; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 6, At any time; n=4 | 2 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 7, Baseline; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 7, Week 8; n=2 | 1 participants |
| Ofatumumab 700 mg IV Infusion | Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter | Treatment Course 7, At any time; n=2 | 1 participants |
Secondary
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response
EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score \<=3.2 and \>1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score \<=3.2 and between \>0.6 and \<=1.2 IfB; DAS28 score between \>3.2 and \<=5.1 and \>1.2 IfB; DAS28 score between \>3.2 and \<=5.1 and between \>0.6 and \<=1.2 IfB; DAS28 score \>5.1 and \>1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants With the Indicated Global Disease Assessment Using the VAS
The participant and the physician independantly used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Number of Participants With the Indicated Pain Score
The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population
Secondary
Ofatumumab Serum Concentration
Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.
Time frame: Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi
Population: FAS Population. Only participants with data available at the particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 1, Baseline (BI); n=92 | 3596.3 Nanograms per milliliter (ng/mL) | Standard Deviation 32324.08 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 1, Baseline (EI); n=91 | 295588.3 Nanograms per milliliter (ng/mL) | Standard Deviation 67754.65 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 3, Week 64; n=1 | NA Nanograms per milliliter (ng/mL) | — |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 4, Baseline (BI); n=20 | 2070.2 Nanograms per milliliter (ng/mL) | Standard Deviation 3329.24 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 4, Baseline (EI); n=20 | 296305.7 Nanograms per milliliter (ng/mL) | Standard Deviation 76863.21 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 4, Week 40; n=1 | NA Nanograms per milliliter (ng/mL) | — |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 5, Baseline (BI); n=8 | 6077.8 Nanograms per milliliter (ng/mL) | Standard Deviation 5853.91 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 5, Baseline (EI); n=8 | 244302.0 Nanograms per milliliter (ng/mL) | Standard Deviation 115157.71 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 5, Week 24; n=2 | 6543.5 Nanograms per milliliter (ng/mL) | Standard Deviation 1229.66 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 6, Baseline (BI); n=4 | 5036.5 Nanograms per milliliter (ng/mL) | Standard Deviation 3099.45 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 6, Baseline (EI); n=4 | 305474.8 Nanograms per milliliter (ng/mL) | Standard Deviation 79304.73 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 6, Week 16; n=2 | 16661.5 Nanograms per milliliter (ng/mL) | Standard Deviation 11651 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 7, Baseline (BI); n=2 | 13262.0 Nanograms per milliliter (ng/mL) | Standard Deviation 9702.92 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 7, Baseline (EI); n=2 | 277168.5 Nanograms per milliliter (ng/mL) | Standard Deviation 25532.92 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 7, Week 8; n=2 | 73159.5 Nanograms per milliliter (ng/mL) | Standard Deviation 19078.45 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 1, Week 104; n=1 | NA Nanograms per milliliter (ng/mL) | — |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 2, Baseline (BI); n=73 | 837.6 Nanograms per milliliter (ng/mL) | Standard Deviation 3102.94 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 2, Baseline (EI); n=92 | 292283.5 Nanograms per milliliter (ng/mL) | Standard Deviation 87672.9 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 2, Week 80; n=1 | NA Nanograms per milliliter (ng/mL) | — |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 3, Baseline (BI); n=53 | 955.0 Nanograms per milliliter (ng/mL) | Standard Deviation 3270.64 |
| Ofatumumab 700 mg IV Infusion | Ofatumumab Serum Concentration | Treatment Course 3, Baseline (EI); n=53 | 276719.3 Nanograms per milliliter (ng/mL) | Standard Deviation 68620.07 |
Secondary
Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood
Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 1, Baseline; n=92 | 6.4 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 4.45 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 1, Week 104; n=1 | 4.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 2, Baseline; n=72 | 1.9 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 3.06 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 4, Baseline; n=20 | 1.7 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 2.68 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 4, Week 40; n=1 | 3.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 5, Baseline; n=8 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 5, Week 24; n=2 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 6, Baseline; n=4 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 6, Week 12; n=4 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 7, Baseline; n=2 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 6, Week 12; n=4 | 82.8 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 5.38 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 4, Week 40; n=1 | 62.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 5, Baseline; n=8 | 53.3 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 12.87 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 5, Week 24; n=2 | 55.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 17.68 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 6, Baseline; n=4 | 51.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 16.06 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 2, Week 80; n=1 | 26.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 3, Baseline; n=53 | 24.1 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 7.83 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 3, Week 64; n=1 | 18.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 4, Baseline; n=20 | 24.6 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 8.24 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 5, Week 24; n=2 | 23.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 7.78 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 6, Baseline; n=4 | 26.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 10.1 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 6, Week 12; n=4 | 24.3 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 11.15 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 7, Baseline; n=2 | 26.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 8.49 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 1, Baseline; n=92 | 79.7 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 7.87 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 2, Week 80; n=1 | 2.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 3, Baseline; n=53 | 2.6 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 2.99 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 3, Week 64; n=1 | 1.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD19+, Treatment Course 7, Week 8; n=2 | 0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 1, Week 104; n=1 | 92.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 2, Baseline; n=72 | 81.9 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 9.23 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 2, Week 80; n=1 | 87.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 3, Baseline; n=53 | 81.4 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 8.84 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 3, Week 64; n=1 | 77.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 4, Baseline; n=20 | 85.4 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 5.09 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 4, Week 40; n=1 | 88.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 5, Baseline; n=8 | 86.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 5.83 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 5, Week 24; n=2 | 88.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 0.71 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 6, Baseline; n=4 | 80.8 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 4.57 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 7, Baseline; n=2 | 87.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 0 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD3+, Treatment Course 7, Week 8; n=2 | 84.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 3.54 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 1, Baseline; n=92 | 51.8 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 11.46 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 1, Week 104; n=1 | 65.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 2, Baseline; n=72 | 53.2 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 10.49 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 2, Week 80; n=1 | 59.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 3, Baseline; n=53 | 53.2 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 10.72 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 3, Week 64; n=1 | 58.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 4, Baseline; n=20 | 56.6 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 13.78 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 6, Week 12; n=4 | 54.8 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 17.75 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 7, Baseline; n=2 | 57.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 9.9 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD4+, Treatment Course 7, Week 8; n=2 | 54.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 16.26 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 1, Baseline; n=92 | 23.7 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 8.61 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 1, Week 104; n=1 | 23.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 2, Baseline; n=72 | 24.2 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 7.94 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 4, Week 40; n=1 | 22.0 Percentage of CD19+, 4+, 8+, and 3+ BCSs | — |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 5, Baseline; n=8 | 27.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 9.47 |
| Ofatumumab 700 mg IV Infusion | Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood | CD8+, Treatment Course 7, Week 8; n=2 | 25.5 Percentage of CD19+, 4+, 8+, and 3+ BCSs | Standard Deviation 10.61 |
Secondary
Ratio of CD 4+/CD8+
Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants with data available at particular time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 3, Week 32; n=2 | 2.40 Ratio of CD 4+/CD8+ cells | Standard Deviation 0.424 |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 4, Baseline; n=1 | 1.50 Ratio of CD 4+/CD8+ cells | — |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 1, Baseline; n=72 | 2.55 Ratio of CD 4+/CD8+ cells | Standard Deviation 1.295 |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 1, Week 48; n=1 | 5.40 Ratio of CD 4+/CD8+ cells | — |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 2, Week 24; n=1 | 4.10 Ratio of CD 4+/CD8+ cells | — |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 2, Week 56; n=1 | 2.60 Ratio of CD 4+/CD8+ cells | — |
| Ofatumumab 700 mg IV Infusion | Ratio of CD 4+/CD8+ | Treatment Course 3, Baseline; n=1 | 2.60 Ratio of CD 4+/CD8+ cells | — |
Secondary
Time to Re-treatment in Each Treatment Course
Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3. The study was terminated by the sponsor after Treatment Course 7; therefore, there are no re-treatment data available for Treatment Course 7.
Time frame: Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population. Only participants available at the indicated time point were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 1, n=73 | 291.01 days | Standard Deviation 127.367 |
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 2, n=53 | 328.83 days | Standard Deviation 122.427 |
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 3, n=20 | 235.95 days | Standard Deviation 93.924 |
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 4, n=8 | 154.88 days | Standard Deviation 19.172 |
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 5, n=4 | 161.75 days | Standard Deviation 22.066 |
| Ofatumumab 700 mg IV Infusion | Time to Re-treatment in Each Treatment Course | Treatment Course 6, n=2 | 120.00 days | Standard Deviation 0 |
Secondary
Whole Blood Transcriptional Profiles
Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.
Time frame: Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.
Population: FAS Population