Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2015-005418-31-ES
• Date of registration: 05/08/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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
• Date of first enrolment: 03/09/2016
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005418-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Double-dummy; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Korea, Republic of, Kuwait, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Departamento Médico (LCO)
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico (LCO)
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
•Male or female patients aged 18 to 55 years (inclusive) at screening
•Diagnosis of MS according to the 2010 Revised McDonald criteria
•Relapsing form of MS: relapsing-remitting course (RRMS), or secondary progressive course with disease activity (relapsing SPMS)
•Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
•At least 1 documented relapse during the previous 1 year OR at least 2 documented relapses during the previous 2 years OR a positive GdE MRI scan during the year prior to randomization and including screening.
•Neurologically stable within 1 month prior to randomization

Please see protocol for complete detailed list of inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Patients with primary progressive MS or SPMS without disease activity
•Disease duration of more than 10 years in patients with EDSS score of 2 or less
•Pregnant or nursing (lactating) women
•Women of child-bearing potential not using highly effective contraception
•Patients with an active chronic disease
•Patients with active systemic infections, or history of or known presence of recurrent or chronic infection
•Have received any live or live-attenuated vaccines within 2 months prior to randomization
•Have been treated with medications as specified within the timeframes specified (e.g. ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, teriflunomide, etc)
•Any other disease or condition which could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.

Please see protocol for complete detailed list of exclusion criteria


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

multiple sclerosis
MedDRA version: 19.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: OMB157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Aubagio
Product Name: Teriflunomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Key secondary objectives

To evaluate if ofatumumab is superior to teriflunomide on:
1. Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on EDSS
2. Number of T1 GdE lesions per MRI scan
3. Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate)
4. Time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on EDSS
5. Rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline
6. Time to disability improvement, as measured by 6-month confirmed improvement (6mCDI) on EDSS

See protocol for complete list of secondary objectives.

Primary end point(s): Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.

Main Objective: Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.

Timepoint(s) of evaluation of this end point: Up to 30 months

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 30 months

Secondary end point(s): -Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on The Expanded Disability Status Scale (EDSS).
-Time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on EDSS.
-Time to disability improvement as measured by 6-month confirmed improvement (6mCDI) on EDSS.
-Number of T1 Gd-enhancing lesions per MRI scan.
-Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate).
-Rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline.

Secondary ID(s)

2015-005418-31-BE

COMB157G2301

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date:
Contact: