Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02792218 |
|
Recruitment Status :
Completed
First Posted : June 7, 2016
Results First Posted : October 19, 2020
Last Update Posted : April 1, 2021
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection Drug: Teriflunomide-matching placebo capsules Drug: Teriflunomide capsule Drug: Matching placebo of ofatumumab subcutaneous injections | Phase 3 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 930 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | September 20, 2016 |
| Actual Primary Completion Date : | July 5, 2019 |
| Actual Study Completion Date : | July 20, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: OMB 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
|
Drug: Ofatumumab subcutaneous injection
Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter Drug: Teriflunomide-matching placebo capsules Placebo capsule, matching in appearance to teriflunomide, 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
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Drug: Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily Drug: Matching placebo of ofatumumab subcutaneous injections Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter |
Primary Outcome Measures :
- Annualized Relapse Rate (ARR) (Confirmed Relapses) [ Time Frame: 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 Outcome Measures :
- 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS [ Time Frame: 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.
- 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS [ Time Frame: 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.
- 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.
- Number of Gd-enhancing T1 Lesions Per MRI Scan [ Time Frame: 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.
- Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) [ Time Frame: 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
- Neurofilament Light Chain (NfL) Concentration in Serum [ Time Frame: 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.
- Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline [ Time Frame: Baseline, months 12 and 24 ]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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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 to 55 years of age
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
- Expanded disability status scale (EDSS) score of 0 to 5.5
Exclusion Criteria:
- Primary progressive MS
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792218
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| L Hospitalet De Llobregat, Catalunya, Spain, 08907 | |
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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Documents (Full-Text)
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan [PDF] October 17, 2019
Study Protocol [PDF] August 6, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02792218 |
| Other Study ID Numbers: |
COMB157G2301 2015-005418-31 ( EudraCT Number ) |
| First Posted: | June 7, 2016 Key Record Dates |
| Results First Posted: | October 19, 2020 |
| Last Update Posted: | April 1, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
Relapsing multiple sclerosis Ofatumumab adult OMB157 multiple sclerosis T1 lesions |
T2 lesions relapse GD-enhancing MRI McDonald criteria RRMS SPMS |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Ofatumumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |