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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02792231
Registration number
NCT02792231
Ethics application status
Date submitted
2/06/2016
Date registered
7/06/2016
Date last updated
22/11/2021
Titles & IDs
Public title
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
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Scientific title
A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.
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Secondary ID [1]
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2015-005419-33
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Secondary ID [2]
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COMB157G2302
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Universal Trial Number (UTN)
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Trial acronym
ASCLEPIOS II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Scelrosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ofatumumab subcutaneous injection
Treatment: Drugs - Teriflunomide-matching placebo capsules
Treatment: Drugs - Teriflunomide capsule
Treatment: Drugs - Matching placebo of ofatumumab subcutaneous injections
Experimental: OMG 20 mg - Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1
,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide-matching placebo, taken orally once daily
Active Comparator: TER 14 mg - Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter
Treatment: Drugs: Ofatumumab subcutaneous injection
Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
Treatment: Drugs: Teriflunomide-matching placebo capsules
Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
Treatment: Drugs: Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily
Treatment: Drugs: Matching placebo of ofatumumab subcutaneous injections
Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualized Relapse Rate (ARR)
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Assessment method [1]
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ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Comparisons were made to the previous rating (the last EDSS rating that did not occur during a relapse).
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Timepoint [1]
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Baseline up to 2.5 years
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Secondary outcome [1]
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3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data
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Assessment method [1]
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A 3-month confirmed disability worsening (3mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 3 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [1]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [2]
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3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302
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Assessment method [2]
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A 3-month confirmed disability worsening (3mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 3 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [2]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [3]
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6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data
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Assessment method [3]
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A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [3]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [4]
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6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302
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Assessment method [4]
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A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [4]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [5]
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6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data
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Assessment method [5]
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A 6-month confirmed disability improvement (6mCDI) was defined as a decrease from baseline EDSS sustained for at least 6 months. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of =2 to 6 or =6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [5]
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0
Baseline, every 3 months up to 2.5 years
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Secondary outcome [6]
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6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302
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Assessment method [6]
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A 6-month confirmed disability improvement (6mCDI) was defined as a decrease from baseline EDSS sustained for at least 6 months. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of =2 to 6 or =6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [6]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [7]
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Number of Gadolinium-enhancing T1 Lesions Per MRI Scan
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Assessment method [7]
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Total number of Gd-enhancing T1 lesions across all scans per patient adjusted for different number of scans due to variable follow-up time in study.
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Timepoint [7]
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Baseline, yearly up to 2.5 years
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Secondary outcome [8]
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Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate)
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Assessment method [8]
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Number of new/enlarging T2 lesions on last available MRI scan compared to baseline adjusted for different time of scans versus baseline due to variable follow up time in study
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Timepoint [8]
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Baseline, yearly up to 2.5 years
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Secondary outcome [9]
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Neurofilament Light Chain (NfL) Concentration in Serum
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Assessment method [9]
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The NfL concentration (geometric mean concentration) was estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.
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Timepoint [9]
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Month 3, 12 and 24
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Secondary outcome [10]
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Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline
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Assessment method [10]
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Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study
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Timepoint [10]
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Baseline, Months 12 and 24
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Secondary outcome [11]
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Participants With Confirmed Relapse
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Assessment method [11]
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A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).
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Timepoint [11]
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Baseline up to 2.5 years
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Secondary outcome [12]
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Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment
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Assessment method [12]
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ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Comparisons were made to the previous rating (the last EDSS rating that did not occur during a relapse).
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Timepoint [12]
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Baseline up to 2.5 years
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Secondary outcome [13]
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3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data
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Assessment method [13]
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A 3-month confirmed disability worsening (3mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 3 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [13]
0
0
Baseline up to 2.5 years
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Secondary outcome [14]
0
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6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data
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Assessment method [14]
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A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [14]
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Baseline up to 2.5 years
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Secondary outcome [15]
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6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data
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Assessment method [15]
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A 6-month confirmed cognitive decline was defined as a decrease from baseline of at least 4 points in SDMT score sustained for at least 6 months. Processing speed was measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint
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Timepoint [15]
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0
Baseline, every 6 months up to 2.5 years
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Secondary outcome [16]
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0
6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data
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Assessment method [16]
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A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of =1.5, for patients with a baseline EDSS of 1 to 5 or =5.5, the criterion for disability worsening was an increase in EDSS of =1 or =0.5, respectively. A 6-month confirmed cognitive decline (6mCCD) was defined as a 4-point worsening on Symbol Digit Modalities Test (SDMT) sustained for at least 6 months. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [16]
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Baseline up to 2.5 years
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Secondary outcome [17]
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Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data
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Assessment method [17]
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0
Processing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [17]
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Baseline up to 2.5 years
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Secondary outcome [18]
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6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data
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Assessment method [18]
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The patient is directed to walk 25 feet quickly and safely as possible from one marked end to the other. The time is calculated from the initiation of the patient instructed to begin, until the patient has reached the 25-foot mark. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [18]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [19]
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6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data
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Assessment method [19]
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9-Hole Peg Test is a test of upper limb function. Participants place 9 pegs on pegboard and remove pegs and this is timed for each hand. Time recorded in seconds. Longer time indicates poorer upper limb function. 20% improvement is defined as 20% shorter time in seconds. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [19]
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Baseline, every 6 months up to 2.5 years
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Secondary outcome [20]
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6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data
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Assessment method [20]
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A 6-month confirmed disability improvement (6mCDI) sustained until EOS was defined as a decrease from baseline EDSS sustained until EOS. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of =2 to 6 or =6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of =1 or =0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.
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Timepoint [20]
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Baseline, every 3 months up to 2.5 years
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Secondary outcome [21]
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Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS)
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Assessment method [21]
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Number of new/enlarging T2 lesions on the last available MRI scan compared to Month 12 adjusted for different time of scans versus Month 12 due to variable follow up time in study.
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Timepoint [21]
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Month 12 up to 2.5 years
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Secondary outcome [22]
0
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Percent Change in T2 Lesion Volume Relative to Baseline
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Assessment method [22]
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Percent change from baseline in total T2 lesion volume
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Timepoint [22]
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Baseline, Month 12, Month 24
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Secondary outcome [23]
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No Evidence of Disease Activity (NEDA-4)
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Assessment method [23]
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NEDA-4 was defined as no 3-month confirmed disability worsening, no confirmed MS relapse, no new or enlarging T2 lesions compared to baseline, and the annualized rate of brain atrophy >-0.04%.
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Timepoint [23]
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Baseline, Month 12, Month 24
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Secondary outcome [24]
0
0
Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline
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Assessment method [24]
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MSIS-29 is a 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life.
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Timepoint [24]
0
0
Baseline, every 6 months up to 2.5 years
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Secondary outcome [25]
0
0
Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline
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Assessment method [25]
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0
MSIS-29 is a 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life.
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Timepoint [25]
0
0
Baseline, every 6 months up to 2.5 years
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Secondary outcome [26]
0
0
Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data
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Assessment method [26]
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0
ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).
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Timepoint [26]
0
0
Baseline up to 2.5 years
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Secondary outcome [27]
0
0
Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data
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Assessment method [27]
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Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate).
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Timepoint [27]
0
0
Baseline, yearly up to 2.5 years
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Secondary outcome [28]
0
0
Brain Volume Loss by NfL High-low Subgroups - Pooled Data
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Assessment method [28]
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0
Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study.
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Timepoint [28]
0
0
Baseline, Months 12 and 24
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Secondary outcome [29]
0
0
Pharmacokinetic (PK) Concentrations of Ofatumumab
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Assessment method [29]
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Summary statistics of pharmacokinetic (PK) concentrations from trough samples collected within a 7-day window prior or at day of dosing.
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Timepoint [29]
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Baseline, Weeks 4, 12, 24, 48, 96
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Eligibility
Key inclusion criteria
- Male or female patients aged 18 to 55 years at Screening
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with
disease activity
- Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during
the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior
to randomization
- Disability status at Screening with an Expanded Disability Status Scale (EDSS) score
of 0 to 5.5
- Neurologically stable within 1 month prior to randomization
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with primary progressive MS or SPMS without disease activity
- Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with
PML
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/10/2020
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Sample size
Target
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Accrual to date
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Final
955
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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0
Novartis Investigative Site - Liverpool
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Recruitment postcode(s) [1]
0
0
2170 - Liverpool
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Delaware
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Minnesota
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Montana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Mexico
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Country [14]
0
0
United States of America
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State/province [14]
0
0
North Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Ohio
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Oregon
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
0
South Carolina
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Tennessee
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Texas
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Utah
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
sclerosis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02792231
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Novartis Pharmaceuticals
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Novartis
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02792231
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