Trial · NCT02792231
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
NCT02792231, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. Trials, record NCT02792231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02792231
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
- NCT number
- NCT02792231
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 955 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing Multiple Scelrosis
- Interventions
- Ofatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, Teriflunomide capsule, Matching placebo of ofatumumab subcutaneous injections
- First posted
- 2016-06-07
- Last updated
- 2021-11-22
- Other registries' IDs
- eudract:2015-005419-33
- Results first posted
- 2020-10-19
- Limitations and caveats
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 COMB157G2301 to address these endpoints.
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | Baseline up to 2.5 years | 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). |
| Secondary | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | 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. |
| Secondary | Number of Gadolinium-enhancing T1 Lesions Per MRI Scan | Baseline, yearly up to 2.5 years | 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. |
| Secondary | Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) | Baseline, yearly up to 2.5 years | 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 |
| Secondary | Neurofilament Light Chain (NfL) Concentration in Serum | Month 3, 12 and 24 | 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate (ARR) | Baseline up to 2.5 years | Full analysis set | number of relapses in a year | MEAN |
| SECONDARY | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | Full analysis set from combined studies | percentage of participants | NUMBER |
| SECONDARY | 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | Full analysis set from combined studies | percentage of participants | NUMBER |
| SECONDARY | 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data | Baseline, every 3 months up to 2.5 years | Full analysis set from combined studies | percentage of participants | NUMBER |
| SECONDARY | 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302 | Baseline, every 3 months up to 2.5 years | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Number of Gadolinium-enhancing T1 Lesions Per MRI Scan | Baseline, yearly up to 2.5 years | Full analysis set | lesions per scan | MEAN |
| SECONDARY | Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) | Baseline, yearly up to 2.5 years | Full analysis set | T2 lesions per year | MEAN |
| SECONDARY | Neurofilament Light Chain (NfL) Concentration in Serum | Month 3, 12 and 24 | Full analysis set | pg/mL | GEOMETRIC_MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate (ARR) | OMB 20 mg | 0.10 | 95% Confidence Interval 0.08 to 0.13 | number of relapses in a year | |
| Annualized Relapse Rate (ARR) | TER 14 mg | 0.25 | 95% Confidence Interval 0.21 to 0.30 | number of relapses in a year | |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | OMB 20 mg | Month 18 - from Kaplan Meier estimates | 9.4 | 95% Confidence Interval 7.6 to 11.5 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | TER 14 mg | Month 18 - from Kaplan Meier estimates | 13.5 | 95% Confidence Interval 11.4 to 16.0 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | OMB 20 mg | Month 24 - from Kaplan Meier estimates | 10.9 | 95% Confidence Interval 8.8 to 13.4 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data | TER 14 mg | Month 24 - from Kaplan Meier estimates | 15.0 | 95% Confidence Interval 12.6 to 17.7 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | OMB 20 mg | Month 18 - from Kaplan Meier estimates | 9.3 | 95% Confidence Interval 6.9 to 12.5 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | TER 14 mg | Month 18 - from Kaplan Meier estimates | 13.2 | 95% Confidence Interval 10.3 to 16.7 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | OMB 20 mg | Month 24 - from Kaplan Meier estimates | 10.5 | 95% Confidence Interval 7.8 to 14.1 | percentage of participants |
| 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 | TER 14 mg | Month 24 - from Kaplan Meier estimates | 14.6 | 95% Confidence Interval 11.5 to 18.6 | percentage of participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OMB 20 mg | 481 | |
| Overall Study | STARTED | TER 14 mg | 474 | |
| Overall Study | COMPLETED | OMB 20 mg | 399 | |
| Overall Study | COMPLETED | TER 14 mg | 390 | |
| Overall Study | NOT COMPLETED | OMB 20 mg | 82 | |
| Overall Study | NOT COMPLETED | TER 14 mg | 84 |
Source ClinicalTrials.gov
Adverse events402
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | OMB 20mg | 28 | 481 | |
| other | Diarrhoea | Gastrointestinal disorders | TER 14mg | 49 | 474 | |
| other | Nausea | Gastrointestinal disorders | OMB 20mg | 30 | 481 | |
| other | Nausea | Gastrointestinal disorders | TER 14mg | 32 | 474 | |
| other | Fatigue | General disorders | OMB 20mg | 25 | 481 | |
| other | Fatigue | General disorders | TER 14mg | 32 | 474 | |
| other | Injection site reaction | General disorders | OMB 20mg | 61 | 481 | |
| other | Injection site reaction | General disorders | TER 14mg | 26 | 474 | |
| other | Influenza | Infections and infestations | OMB 20mg | 30 | 481 | |
| other | Influenza | Infections and infestations | TER 14mg | 30 | 474 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OMB 20mg | 0 | 481 |
| Total, all-cause mortality | TER 14mg | 1 | 474 |
| Total, other adverse events | OMB 20mg | 348 | 481 |
| Total, other adverse events | TER 14mg | 322 | 474 |
| Total, serious adverse events | OMB 20mg | 42 | 481 |
| Total, serious adverse events | TER 14mg | 37 | 474 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OMB 20mg vs TER 14mg: deaths from any cause | Trial comparisons |
| OMB 20mg vs TER 14mg: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02792231
GET https://conductscience.org/api/trials/v1/NCT02792231/registered?page=2