Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis (MIRROR)
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ClinicalTrials.gov Identifier: NCT01457924 |
Recruitment Status :
Completed
First Posted : October 24, 2011
Results First Posted : March 1, 2018
Last Update Posted : June 6, 2018
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Multiple Sclerosis |
Interventions |
Drug: Ofatumumab 3mg Drug: Ofatumumab 30mg Drug: Ofatumumab 60mg Drug: Placebo |
Enrollment | 232 |
Participant Flow
Recruitment Details | 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. |
Pre-assignment Details | 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. |
Arm/Group Title | Placebo/Ofatumumab 3 mg | Ofatumumab 3 mg q12w | Ofatumumab 30 mg q12w | Ofatumumab 60 mg q12w | Ofatumumab 60mg q4w |
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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. | 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. | 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. | 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. | 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. |
Period Title: Treatment Phase (Weeks 0-24) | |||||
Started | 67 | 34 | 32 | 34 | 64 |
Completed to Week 12 | 65 | 31 | 30 | 33 | 60 |
Completed | 64 | 29 | 30 | 33 | 58 |
Not Completed | 3 | 5 | 2 | 1 | 6 |
Reason Not Completed | |||||
Adverse Event | 0 | 4 | 1 | 0 | 2 |
Physician Decision | 0 | 0 | 0 | 0 | 1 |
Lack of Efficacy | 1 | 0 | 0 | 0 | 0 |
Protocol Violation | 1 | 0 | 1 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 |
Other-Protocol defined stopping criteria | 1 | 1 | 0 | 0 | 2 |
Period Title: FUP (Weeks 24-48) | |||||
Started [1] | 66 | 31 | 32 | 33 | 59 |
Completed | 63 | 30 | 30 | 32 | 57 |
Not Completed | 3 | 1 | 2 | 1 | 2 |
Reason Not Completed | |||||
Adverse Event | 0 | 0 | 1 | 0 | 0 |
Physician Decision | 1 | 0 | 1 | 0 | 0 |
Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
Withdrawal by Subject | 2 | 1 | 0 | 0 | 2 |
[1]
A total of 221 par. entered the FUP, including 7 of the 17 par. who were withdrawn before Week 24.
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Period Title: Individualized FUP (Weeks 48+) | |||||
Started [1] | 16 | 18 | 16 | 20 | 42 |
Completed | 11 | 14 | 12 | 15 | 36 |
Not Completed | 5 | 4 | 4 | 5 | 6 |
Reason Not Completed | |||||
Lost to Follow-up | 1 | 0 | 1 | 0 | 0 |
Other-Protocol defined stopping criteria | 3 | 4 | 2 | 3 | 5 |
Withdrawal by Subject | 1 | 0 | 1 | 2 | 1 |
[1]
Par. whose CD19+ B lymphocyte counts had not recovered to lower limit of normal entered IFU phase.
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Baseline Characteristics
Arm/Group Title | Placebo/Ofatumumab 3 mg | Ofatumumab 3 mg q12w | Ofatumumab 30 mg q12w | Ofatumumab 60 mg q12w | Ofatumumab 60mg q4w | Total | |
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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. | 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. | 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. | 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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 67 | 34 | 32 | 34 | 64 | 231 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 67 participants | 34 participants | 32 participants | 34 participants | 64 participants | 231 participants | |
37.7 (9.38) | 38.1 (8.29) | 37.2 (10.04) | 37.3 (9.67) | 36.2 (9.57) | 37.2 (9.36) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 67 participants | 34 participants | 32 participants | 34 participants | 64 participants | 231 participants | |
Female |
46 68.7%
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22 64.7%
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24 75.0%
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22 64.7%
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41 64.1%
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155 67.1%
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Male |
21 31.3%
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12 35.3%
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8 25.0%
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12 35.3%
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23 35.9%
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76 32.9%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 67 participants | 34 participants | 32 participants | 34 participants | 64 participants | 231 participants |
African American/African Heritage | 1 | 0 | 0 | 0 | 1 | 2 | |
Asian - East Asian Heritage | 0 | 0 | 1 | 0 | 0 | 1 | |
White - White/Caucasian/European Heritage | 65 | 34 | 31 | 34 | 61 | 225 | |
Mixed Race | 1 | 0 | 0 | 0 | 2 | 3 |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01457924 |
Other Study ID Numbers: |
112831 |
First Submitted: | October 20, 2011 |
First Posted: | October 24, 2011 |
Results First Submitted: | March 21, 2017 |
Results First Posted: | March 1, 2018 |
Last Update Posted: | June 6, 2018 |