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Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation.
This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.
Ofatumumab is a novel immunoglobulin G (IgG) 1ĸ lytic monoclonal antibody (mAb) that specifically binds to the human CD20 antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with rituximab demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in Relapsing-Remitting Multiple Sclerosis (RRMS). The intravenous (IV) formulation of ofatumumab has been shown to be both well-tolerated and efficacious in Phase I/II & III clinical trials within in B-cell Chronic Lymphocytic Leukemia (B-CLL), non-Hodgkin's Follicular Lymphoma (FL), and active Rheumatoid Arthritis (RA). A Phase II study of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) subjects, OMS115102 (also known as Study GEN414) is ongoing as of the development of this protocol. The primary objective of the OMS115102 protocol was to investigate the safety of a range of doses (100mg, 300 mg, and 700 mg) of ofatumumab in RRMS subjects, using an IV formulation. The treatment period for OMS115102 has been completed; there are currently 4 subjects ongoing in the Individualized Follow up Phase. In the Week 0 to 24 period the majority of subject who were exposed to active treatment with ofatumumab (active/placebo) had Cluster of Differentiation 19 (CD19+) and CD20+ levels that were suppressed to zero; recovery started for the 100 mg and 300 mg active/placebo groups, at approximately, 12 and 20 weeks after discontinuation of dosing with ofatumumab, respectively. In the 700 mg active/placebo group, all but one subject had a persistent and complete CD19+ suppression at Week 24. In the Week 24 to 48 period, when those who had previously been exposed to placebo were treated with ofatumumab (placebo/active), the majority of the subjects treated with ofatumumab had CD19+ and CD20+ cell levels suppressed to zero (mm3) within one week. Recovery started for the subjects in the 100 mg placebo/active group after approximately 16 weeks (from these subjects' first infusion). In the 300 mg and 700 mg placebo/active groups, all subjects except one (700 mg) had persistent and complete CD19+ suppression at Week 48.
This study will evaluate the magnetic resonance imaging (MRI) efficacy and will investigate the safety of ofatumumab using a subcutaneous (SQ) formulation in subjects with RRMS. This Phase II study will be a multi-center, randomized, double-blind, placebo-controlled, dose ranging study in subjects with RRMS. Randomization will be stratified based on the absence or presence of GdE brain lesions present at screening. The core 54 week period of the study is made up of an up to 6-week Screening Phase, a 24-week Treatment Phase, and a 24-week Follow-up Phase. Subjects will attend the clinic a total of approximately twelve times (including Screening) during this core 54-week period of the study. Subjects who have remained enrolled and participate in the study from Screening though the end of the 24-Week Follow-Up Period (Week 48 Visit) will be considered completers. Upon completion or withdrawal from the core study period, subjects will be followed in the Individualized Follow-up Phase. Subjects will return to the clinic every 12 weeks for a B-cell count and other safety assessments. Subjects will remain in Individualized Follow-up (IFU) until CD19+ B-lymphocyte counts recover to LLN or baseline (if <LLN);OR if B-cell counts have not recovered by the Week 120 visit (100 weeks after the last possible treatment dose at Week 20), until either the B-cell counts or circulating IgG are >LLN or baseline levels (if \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Placebo and one dose of Ofatumumab 3mg over 24 weeks |
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| Cohort 2 | Experimental | Two doses of Ofatumumab 3mg over 24 weeks |
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| Cohort 3.1 | Experimental | Two doses of Ofatumumab 30mg over 24 weeks |
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| Cohort 3.2 | Experimental | Conditioning dose of Ofatumumab 3mg at randomization, two doses of Ofatumumab 30mg over 24 weeks |
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| Cohort 4.1 | Experimental | Two doses of Ofatumumab 60mg over 24 weeks |
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| Cohort 4.2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab 3mg | Drug | 3mg of investigational product |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 | The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of New GdE T1 Lesions at Week 24 | The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed. |
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Inclusion Criteria:
Oral contraceptives (either combined or progesterone only) Injectable progesterone Levonorgestrel implants Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of <1% per year Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; this male must be the sole partner for the subject Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
A female is considered "Non-childbearing potential" if she is status-post hysterectomy, status-post surgical removal of both ovaries, has current, documented tubal ligation, or is postmenopausal and >2 years without menses. Female subjects who are post-menopausal <2 years must be confirmed menopausal by Follicle Stimulating Hormone (FSH) and estradiol levels.
A female is considered "childbearing potential" if she has functional ovaries, ducts, and uterus with no impairment that would cause sterility. This includes women with oligomenorrhea (even severe), and women who are perimenopausal or who have just begun to menstruate.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cullman | Alabama | 35058 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29695594 | Derived | Bar-Or A, Grove RA, Austin DJ, Tolson JM, VanMeter SA, Lewis EW, Derosier FJ, Lopez MC, Kavanagh ST, Miller AE, Sorensen PS. Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study. Neurology. 2018 May 15;90(20):e1805-e1814. doi: 10.1212/WNL.0000000000005516. Epub 2018 Apr 25. |
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A total of 324 par. with Relapsing-Remitting Multiple Sclerosis (RRMS) were screened and 232 par. were randomized to 24 Week Treatment Phase (Weeks 0-12 were placebo controlled) of the study. A total of 231 par. received at least one dose of double-blind Investigational Product (IP) and were included in the Safety Population.
A participant (par.) completed the study if he/she completed all assessments up to and including the 24 Week Follow-up Phase (FUP) (Week 48) without prematurely discontinuing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Ofatumumab 3 mg | Par. received ofatumumab matching placebo subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 to Week 20, except on Week 12 participants received 3 milligrams (mg) ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 gram (g) and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase (Weeks 0-24) |
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Conditioning dose of Ofatumumab 3mg at randomization, two doses of Ofatumumab 60mg over 24 weeks
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| Cohort 5.1 | Experimental | Six doses of Ofatumumab 60mg over 24 weeks |
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| Cohort 5.2 | Experimental | Conditioning dose of Ofatumumab 3mg at randomization, six doses of Ofatumumab 60mg over 24 weeks |
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| Ofatumumab 30mg | Drug | 30mg of investigational product |
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| Ofatumumab 60mg | Drug | 60mg of investigational product |
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| Placebo | Drug | Placebo |
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| Week 24 |
| Change From Baseline in Brain Volume at Week 24 and Week 48 | Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. | Baseline (Week 0), Week 24 and Week 48 |
| Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12 | The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | Week 12 |
| Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12 | The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | Week 12 |
| Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | Week 12 |
| Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | Week 12 |
| Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12 | The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | Week 12 |
| Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | Week 12 |
| Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48 | The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | Week 24 and Week 48 |
| Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48 | Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant's last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | Baseline, Week 24 and Week 48 |
| Fullerton |
| California |
| 92835 |
| United States |
| GSK Investigational Site | Fairfield | Connecticut | 06824 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Sunrise | Florida | 33351 | United States |
| GSK Investigational Site | Tampa | Florida | 33612 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30327 | United States |
| GSK Investigational Site | Northbrook | Illinois | 60062 | United States |
| GSK Investigational Site | Fort Wayne | Indiana | 46805 | United States |
| GSK Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37204 | United States |
| GSK Investigational Site | Round Rock | Texas | 78681 | United States |
| GSK Investigational Site | Seattle | Washington | 98122 | United States |
| GSK Investigational Site | Sofia | 1000 | Bulgaria |
| GSK Investigational Site | Sofia | 1113 | Bulgaria |
| GSK Investigational Site | Sofia | 1309 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Edmonton | Alberta | T6G 1Z1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3A 2B4 | Canada |
| GSK Investigational Site | Brno | 625 00 | Czechia |
| GSK Investigational Site | Brno | 656 91 | Czechia |
| GSK Investigational Site | Jihlava | 586 33 | Czechia |
| GSK Investigational Site | Olomouc | 775 20 | Czechia |
| GSK Investigational Site | Teplice | 415 29 | Czechia |
| GSK Investigational Site | Koebenhavn Ø | 2100 | Denmark |
| GSK Investigational Site | Alzenau in Unterfranken | Bavaria | 63755 | Germany |
| GSK Investigational Site | Achim | Lower Saxony | 28832 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50935 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Berlin | 10961 | Germany |
| GSK Investigational Site | Berlin | 12163 | Germany |
| GSK Investigational Site | Hamburg | 22087 | Germany |
| GSK Investigational Site | Modena | Emilia-Romagna | 41126 | Italy |
| GSK Investigational Site | Verona | Veneto | 37134 | Italy |
| GSK Investigational Site | Sittard-geleen | 6162 BG | Netherlands |
| GSK Investigational Site | Venray | 5801 CE | Netherlands |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Kazan' | 420021 | Russia |
| GSK Investigational Site | Moscow | 107150 | Russia |
| GSK Investigational Site | Moscow | 119049 | Russia |
| GSK Investigational Site | Moscow | 127018 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603126 | Russia |
| GSK Investigational Site | Saint Petersburg | 194291 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Smolensk | 214018 | Russia |
| GSK Investigational Site | Baracaldo/Vizcaya | 48903 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Castellon | 12004 | Spain |
| GSK Investigational Site | Córdoba | 14001 | Spain |
| GSK Investigational Site | Girona | 17007 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Seville | 41071 | Spain |
| FG001 | Ofatumumab 3 mg q12w | Par. received ofatumumab 3 mg SC injection every 12th week (q12w) on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| FG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| FG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| FG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| Completed to Week 12 |
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| COMPLETED |
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| NOT COMPLETED |
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| FUP (Weeks 24-48) |
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| Individualized FUP (Weeks 48+) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Ofatumumab 3 mg | Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| BG001 | Ofatumumab 3 mg q12w | Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| BG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| BG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| BG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 | The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed. | Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of IP and who had at least one post screen MRI assessment. Only those par. available at the specified time points were analyzed. Please see footnote of statistical analysis 1 for discrepancy in analysis population Week 24 and 48. | Posted | Mean | Standard Deviation | Cumulative number of lesions | Week 12 |
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| Secondary | Cumulative Number of New GdE T1 Lesions at Week 24 | The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cumulative number of lesions | Week 24 |
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| Secondary | Change From Baseline in Brain Volume at Week 24 and Week 48 | Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cubic centimeters | Baseline (Week 0), Week 24 and Week 48 |
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| Secondary | Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12 | The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Number of lesions per scan | Week 12 |
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| Secondary | Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12 | The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cumulative number of lesions | Week 12 |
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| Secondary | Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cubic millimeter (mm^3) | Week 12 |
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| Secondary | Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | mm^3 | Week 12 |
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| Secondary | Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12 | The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cumulative number of lesions | Week 12 |
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| Secondary | Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12 | Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | mm^3 | Week 12 |
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| Secondary | Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48 | The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Number of lesions | Week 24 and Week 48 |
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| Secondary | Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48 | Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant's last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. | ITT Population. Only those par. available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | mm^3 | Baseline, Week 24 and Week 48 |
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On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 24).
SAEs and non-serious AEs were reported for members of the safety population, comprised of all par. who were randomized to treatment, and received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Ofatumumab 3 mg | Par. received ofatumumab matching placebo SC injection q4w from Week 0 to Week 20, except on Week 12 participants received 3 mg ofatumumab SC injection. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. | 0 | 67 | 0 | 67 | 41 | 67 |
| EG001 | Ofatumumab 3 mg q12w | Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. | 0 | 34 | 1 | 34 | 20 | 34 |
| EG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. | 0 | 32 | 0 | 32 | 23 | 32 |
| EG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. | 0 | 34 | 1 | 34 | 22 | 34 |
| EG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. | 0 | 64 | 4 | 64 | 47 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Reticulocyte count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Blood immunoglobulin G decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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The incorrect exclusion of one par. from ITT pop. at Wk 24 was not considered to impact overall interpretation of data: no updates were made to source tables/analyses. This par. had withdrawn early, having never received a dose of active study drug.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527517 | ofatumumab |
Not provided
Not provided
Not provided
| Physician Decision |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Other-Protocol defined stopping criteria |
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| Withdrawal by Subject |
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| Male |
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| Asian - East Asian Heritage |
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| White - White/Caucasian/European Heritage |
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| Mixed Race |
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| Non-Linear Emax Model | <0.001 | Ratio | 0.35 | 2-Sided | 95 | 0.221 | 0.548 | Superiority or Other |
| Non-Linear Emax Model | <0.001 | Ratio | 0.35 | 2-Sided | 95 | 0.221 | 0.548 | Superiority or Other |
| Non-Linear Emax Model | <0.001 | Ratio | 0.35 | 2-Sided | 95 | 0.221 | 0.548 | Superiority or Other |
| OG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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| OG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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| OG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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Par. received ofatumumab 3 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 0, 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
| OG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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| OG002 | Ofatumumab 30 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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|
| Ofatumumab 30 mg q12w |
Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product.
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
|
|
| Ofatumumab 30 mg q12w |
Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 30 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG003 | Ofatumumab 60 mg q12w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q12w on Week 1 and Week 12. Participants received matching placebo on Weeks 4, 8, 16 and 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
| OG004 | Ofatumumab 60mg q4w | Par. received ofatumumab 3 mg conditioning dose SC injection or matching placebo on Week 0 and received ofatumumab 60 mg SC injection q4w from Week 1 to Week 20. Participants also received pre-medication of acetaminophen 1 g and antihistamine (cetirizine or equivalent) 10 mg prior to administration of each SC injection of investigational product. |
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