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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02792231




Registration number
NCT02792231
Ethics application status
Date submitted
2/06/2016
Date registered
7/06/2016
Date last updated
8/10/2019

Titles & IDs
Public title
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
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.
Secondary ID [1] 0 0
2015-005419-33
Secondary ID [2] 0 0
COMB157G2302
Universal Trial Number (UTN)
Trial acronym
ASCLEPIOS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Scelrosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ofatumumab subcutaneous injection
Treatment: Drugs - Placebo orally matching to teriflunomide
Treatment: Drugs - Teriflunomide orally
Treatment: Drugs - Placebo subcutaneous injection matching to ofatumumab

Experimental: Ofatumumab - Syringes for subcutaneous injection
Patients will also take a placebo capsule (matching in appearance to teriflunomide)

Active Comparator: Teriflunomide - Oral capsule
Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab)


Treatment: Drugs: Ofatumumab subcutaneous injection
Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks

Treatment: Drugs: Placebo orally matching to teriflunomide
Placebo orally, matching in appearance to teriflunomide, administered once daily

Treatment: Drugs: Teriflunomide orally
Patients randomized to the teriflunomide arm will take teriflunomide orally once daily

Treatment: Drugs: Placebo subcutaneous injection matching to ofatumumab
Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized relapse rate (ARR) - ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
Timepoint [1] 0 0
up to 2.5 years
Secondary outcome [1] 0 0
Time to 3-month confirmed disability worsening on EDSS - A 3-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3 months.
Timepoint [1] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [2] 0 0
Time to 6-month confirmed disability worsening on EDSS - A 6-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 6 months.
Timepoint [2] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [3] 0 0
Time to 6-month confirmed disability improvement on EDSS - A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.
Timepoint [3] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [4] 0 0
Number of gadolinium (Gd)-enhancing lesions per MRI scan - Total number of Gd-enhancing lesions across all scans per patient adjusted for different number of scans due to variable follow up time in study
Timepoint [4] 0 0
Baseline, yearly up to 2.5 years
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline, yearly up to 2.5 years
Secondary outcome [6] 0 0
Neurofilament light chain (Nfl) concentration in serum - The NfL concentration (geometric mean concentration) will be estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.
Timepoint [6] 0 0
Baseline, every 3 months up to 2.5 years
Secondary outcome [7] 0 0
Rate of brain volume loss based on assessments of percentage 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
Timepoint [7] 0 0
Baseline, yearly up to 2.5 years

Eligibility
Key inclusion criteria
- Diagnosis of multiple sclerosis (MS)

- Relapsing MS (RRMS or SPMS) course

- 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

- EDSS score of 0 to 5.5
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment outside Australia
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02792231
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications