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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005418-31 | EudraCT Number |
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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
This was a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years.
Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMB 20 mg | Experimental | 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 |
|
| TER 14 mg | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab subcutaneous injection | Drug | Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | 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). | Baseline up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85013 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39018512 | Derived | Williams MJ, Amezcua L, Cohan SL, Cohen JA, Delgado SR, Hua LH, Lucassen EB, Piccolo RS, Koulouris CR, Stankiewicz J. Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses. Neurology. 2024 Aug 13;103(3):e209610. doi: 10.1212/WNL.0000000000209610. Epub 2024 Jul 17. | |
| 37606897 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 1277 patients were screened, of whom 927 patients were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OMB 20 mg | Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily) |
| FG001 | TER 14 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Sep 18, 2020 |
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| Teriflunomide-matching placebo capsules | Drug | Placebo capsule, matching in appearance to teriflunomide, taken orally once daily |
|
| Teriflunomide capsule | Drug | Teriflunomide 14 mg oral capsule taken once daily |
|
| Matching placebo of ofatumumab subcutaneous injections | Drug | Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter |
|
| Baseline, every 3 months up to 2.5 years |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| Number of Gd-enhancing T1 Lesions Per MRI Scan | 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. | Baseline, yearly up to 2.5 years |
| Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) | 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 | Baseline, yearly up to 2.5 years |
| Neurofilament Light Chain (NfL) Concentration in Serum | 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. | Month 3, 12 and 24 |
| Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline | 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 | Baseline, months 12 and 24 |
| Percentage of Participants With Confirmed Relapse | 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). | Baseline up to 2.5 years |
| Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment | 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). | Baseline up to 2.5 years |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline up to 2.5 years |
| 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline up to 2.5 years |
| 6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data | 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 COMB157G2302 to address this endpoint | Baseline, every 6 months up to 2.5 years |
| 6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline up to 2.5 years |
| Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data | 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. | Baseline up to 2.5 years |
| 6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| 6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline, every 6 months up to 2.5 years |
| 6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Baseline, every 3 months up to 2.5 years |
| Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS) | 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. | Month 12 up to 2.5 years |
| Percent Change in T2 Lesion Volume Relative to Baseline | Percent change from baseline in total T2 lesion volume | Baseline, Month 12, Month 24 |
| No Evidence of Disease Activity (NEDA-4) | 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%. | Baseline, Month 12, Month 24 |
| Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline | 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. | Baseline, every 6 months up to 2.5 years |
| Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline | 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. | Baseline, every 6 months up to 2.5 years |
| Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data | 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). | Baseline up to 2.5 years |
| Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data | Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate). | Baseline, yearly up to 2.5 years |
| Annual Rate of Percent Change in Brain Volume Loss by NfL High-low Subgroups - Pooled Data | 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. | Baseline, Months 12 and 24 |
| Pharmacokinetic (PK) Concentrations of Ofatumumab | Summary statistics of pharmacokinetic (PK) concentrations from trough samples collected within a 7-day window prior or at day of dosing. | Baseline, Weeks 4, 12, 24, 48, 96 |
| Berkeley |
| California |
| 94705 |
| United States |
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| Novartis Investigative Site | Banská Bystrica | 97517 | Slovakia |
| Novartis Investigative Site | Bratislava | 82606 | Slovakia |
| Novartis Investigative Site | Bratislava | 83305 | Slovakia |
| Novartis Investigative Site | Nitra | 94901 | Slovakia |
| Novartis Investigative Site | Trnava | 917 75 | Slovakia |
| Novartis Investigative Site | Cadiz | Andalusia | 11009 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08026 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Salt | Catalonia | 17190 | Spain |
| Novartis Investigative Site | El Palmar | Murcia | 30120 | Spain |
| Novartis Investigative Site | Barcelona | 08003 | Spain |
| Novartis Investigative Site | Valencia | 46026 | Spain |
| Novartis Investigative Site | Gothenburg | 413 45 | Sweden |
| Novartis Investigative Site | Stockholm | 102 35 | Sweden |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Khon Kaen | THA | 40002 | Thailand |
| Novartis Investigative Site | Istanbul | 34147 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Samsun | 55139 | Turkey (Türkiye) |
| Novartis Investigative Site | Headington | Oxfordshire | OX3 9DU | United Kingdom |
| Novartis Investigative Site | Glasgow | G51 4TF | United Kingdom |
| Novartis Investigative Site | London | E1 1BB | United Kingdom |
| Bhan V, Clift F, Baharnoori M, Thomas K, Patel BP, Blanchette F, Adlard N, Vudumula U, Gudala K, Dutta N, Grima D, Mouallif S, Farhane F. Cost-consequence analysis of ofatumumab for the treatment of relapsing-remitting multiple sclerosis in Canada. J Comp Eff Res. 2023 Sep;12(9):e220175. doi: 10.57264/cer-2022-0175. Epub 2023 Aug 22. |
| 35266417 | Derived | Gartner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Haring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10. |
| 32757523 | Derived | Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Haring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246. |
Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OMB 20 mg | Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily) |
| BG001 | TER 14 mg | Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter) |
| BG002 | 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 | Count of Participants | Participants |
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| Number of relapses in the past 12 months prior to screening | Reported numbers are from investigator records | Mean | Standard Deviation | Number of relapses |
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| Expanded Disability Status Scale (EDSS) | The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). | Participants with data that met requirements for analysis were included | Mean | Standard Deviation | Score on a scale |
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| Number of Gd-enhancing T1 lesions | Magnetic Resonance Imaging (MRI) scans of the brain were were read by the central MRI reading center. The central reading center was blinded with no access to information on treatment assignments | Participants with data that met requirements for analysis were included | Mean | Standard Deviation | T1 lesions |
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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 | Annualized Relapse Rate (ARR) | 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). | Full analysis set | Posted | Mean | 95% Confidence Interval | number of relapses in a year | Baseline up to 2.5 years |
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| Secondary | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Meta analysis set | Posted | Mean | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2301 | 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 COMB157G2302 to address this endpoint. | Posted | Mean | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | Number of Gd-enhancing T1 Lesions Per MRI Scan | 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. | Full analysis set | Posted | Mean | 95% Confidence Interval | lesions per scan | Baseline, yearly up to 2.5 years |
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| Secondary | Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) | 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 | Full analysis set | Posted | Mean | 95% Confidence Interval | T2 lesions per year | Baseline, yearly up to 2.5 years |
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| Secondary | Neurofilament Light Chain (NfL) Concentration in Serum | 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. | Full analysis set | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Month 3, 12 and 24 |
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| Secondary | Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline | 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 | Full analysis set | Posted | Mean | 95% Confidence Interval | percentage of brain volume loss | Baseline, months 12 and 24 |
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| Secondary | Percentage of Participants With Confirmed Relapse | 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). | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 2.5 years |
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| Secondary | Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment | 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). | Full analysis set | Posted | Mean | 95% Confidence Interval | number of relapses in a year | Baseline up to 2.5 years |
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| Secondary | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data | 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 COMB157G2302 to address this endpoint. | It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Mean | 95% Confidence Interval | percentage of participants | Baseline up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data | 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 COMB157G2302 to address this endpoint. | It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Mean | 95% Confidence Interval | percentage of participants | Baseline up to 2.5 years |
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| Secondary | 6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data | 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 COMB157G2302 to address this endpoint | It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 6 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data | 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 COMB157G2302 to address this endpoint. | Full analysis set. It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 2.5 years |
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| Secondary | Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data | 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. | Full analysis set. It was pre-specified in the study protocol/SAP that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Mean | 95% Confidence Interval | scores | Baseline up to 2.5 years |
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| Secondary | 6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data | 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 COMB157G2302 to address this endpoint. | Full analysis set. It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | 6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data | 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 COMB157G2302 to address this endpoint. | It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 6 months up to 2.5 years |
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| Secondary | 6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data | 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 COMB157G2302 to address this endpoint. | Full analysis set. It was pre-specified in the study protocol that data for this outcome measure will be combined with data from study COMB157G2302. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 3 months up to 2.5 years |
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| Secondary | Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS) | 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. | Full analysis set | Posted | Mean | 95% Confidence Interval | T2 lesions per year | Month 12 up to 2.5 years |
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| Secondary | Percent Change in T2 Lesion Volume Relative to Baseline | Percent change from baseline in total T2 lesion volume | Full analysis set | Posted | Mean | Standard Deviation | percentage change in lesion volume | Baseline, Month 12, Month 24 |
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| Secondary | No Evidence of Disease Activity (NEDA-4) | 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%. | Full analysis set. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 12, Month 24 |
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| Secondary | Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline | 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. | Full analysis set | Posted | Mean | Standard Error | scores on a scale | Baseline, every 6 months up to 2.5 years |
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| Secondary | Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline | 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. | Full analysis set | Posted | Mean | Standard Error | scores on a scale | Baseline, every 6 months up to 2.5 years |
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| Secondary | Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data | 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). | Supportive sub-group analysis based on estimations from pooled data from this study and study COMB157G2302. | Posted | Mean | 95% Confidence Interval | number of relapses in a year | Baseline up to 2.5 years |
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| Secondary | Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data | Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate). | Supportive sub-group analysis based on estimations from pooled data from this study and study COMB157G2302. | Posted | Mean | 95% Confidence Interval | T2 lesions per year | Baseline, yearly up to 2.5 years |
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| Secondary | Annual Rate of Percent Change in Brain Volume Loss by NfL High-low Subgroups - Pooled Data | 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. | Supportive sub-group analysis based on estimations from pooled data from this study and study COMB157G2302. | Posted | Mean | 95% Confidence Interval | percentage of brain volume loss | Baseline, Months 12 and 24 |
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| Secondary | Pharmacokinetic (PK) Concentrations of Ofatumumab | Summary statistics of pharmacokinetic (PK) concentrations from trough samples collected within a 7-day window prior or at day of dosing. | Full analysis set | Posted | Mean | Standard Deviation | ug/mL | Baseline, Weeks 4, 12, 24, 48, 96 |
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Adverse events were reported from first dose of study treatment until end of study treatment plus 100 days post treatment, up to a maximum duration of 2.7 years.
Not provided
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 | OMB 20mg | Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily) | 0 | 465 | 51 | 465 | 282 | 465 |
| EG001 | TER 14mg | Teriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter) | 0 | 462 | 39 | 462 | 308 | 462 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholelithiasis migration | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Abscess sweat gland | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Tick-borne viral encephalitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Psychiatric evaluation | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Femoroacetabular impingement | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Morphoea | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Fibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hemiplegic migraine | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Blood immunoglobulin M decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
This study was not powered for the analysis of some secondary endpoints as a stand-alone study. It was pre-specified in the study protocol to combine the data with study COMB157G2302 to address these endpoints.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2019 | Sep 18, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C527525 | teriflunomide |
Not provided
Not provided
Not provided
|
|
| Black or African American |
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| White |
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| Other |
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| Unknown |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline n=304 |
|
| ||||
| Week 4 n=347 |
|
| ||||
| Week 12 n=323 |
|
| ||||
| Week 24 n=304 |
|
| ||||
| Week 48 n=270 |
|
| ||||
| Week 96 n=336 |
|
|