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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/03/008181
Date of registration: 22-03-2017
Prospective Registration: Yes
Primary sponsor: Novartis Healthcare Pvt Ltd
Public title: Study of 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
Date of first enrolment: 04-04-2017
Target sample size: 900
Recruitment status: Closed to Recruitment of Participants
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16236
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy
 
Phase:  Phase 3
Countries of recruitment
Argentina Australia Bulgaria Canada Chile Croatia Czech Republic Denmark
Estonia France Germany Greece Hungary India Israel Italy
Kuwait Mexico Netherlands Poland Portugal Romania Russian Federation Saudi Arabia
Slovakia Spain Sweden Switzerland Thailand Turkey United Kingdom United States of America
Contacts
Name: Murugananthan K   
Address:  Novartis Healthcare Pvt Ltd Sandoz House, 5th floor Shivsagar Estate Dr. Annie Besant Road Worli, Mumbai 400 018 INDIA Mumbai MAHARASHTRA 400018 India 400018 Mumbai, MAHARASHTRA India
Telephone: 912224958545
Email: murugananthan.k@novartis.com
Affiliation:  Novartis Healthcare Pvt. Ltd
Name: Murugananthan K   
Address:  Novartis Healthcare Pvt Ltd Sandoz House, 5th floor Shivsagar Estate Dr. Annie Besant Road Worli, Mumbai 400 018 INDIA Mumbai MAHARASHTRA 400018 India 400018 Mumbai, MAHARASHTRA India
Telephone: 912224958545
Email: murugananthan.k@novartis.com
Affiliation:  Novartis Healthcare Pvt. Ltd
Key inclusion & exclusion criteria
Inclusion criteria: Diagnosis of multiple sclerosis (MS)

1.Relapsing MS (RRMS or SPMS) course

2.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

3.EDSS score of 0 to 5.5


Exclusion criteria: Primary progressive MS

1.Disease duration of more than 10 years in patients with an EDSS score of 2 or less

2.Patients with an active chronic disease of the immune system other than MS

3.Patients at risk of developing or having reactivation of hepatitis

4.Patients with active systemic infections or with neurological findings consistent with PML

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Relapsing Multiple Sclerosis
Intervention(s)
Intervention1: Drug: Ofatumumab subcutaneous injection: Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab. Dose: 20 mg ofatumumab. Dosage: Every 4 weeks. Route of administration: Subcutaneous. Duration: Max 30 months(2.5 years).
Intervention2: Drug: Placebo subcutanous injection matching to ofatumumab: Placebo-containing syringes, matching in appearance to syringes containing ofatumumab. Dose: 0 mg ofatumumab. Dosage: Every 4 weeks. Route of administration: Subcutaneous. Duration: Max 30 months(2.5 years).
Control Intervention1: Drug: (over-encapsulated tablets)Teriflunomide orally: Teriflunomide, (over-encapsulated tablets) Dose:14 mg Dosage: once daily. Route of administration: Oral Duration: Max 30 months (2.5 years)
Control Intervention2: Drug: Placebo orally matching to teriflunomide.(over-encapsulated tablets).: Placebo orally, matching in appearance to teriflunomide, (over-encapsulated tablets) Dose:0mg Dosage: once daily. Route of administration: Oral Duration: Max 30 months (2.5 years)
Primary Outcome(s)
Annualized relapse rate (ARR)Timepoint: Time Frame: up to 2.5 years
Secondary Outcome(s)
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 studyTimepoint: Time Frame: Baseline, yearly up to 2.5 years
Time to 3-month confirmed disability worsening on EDSSTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years
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 studyTimepoint: Time Frame: Baseline, yearly up to 2.5 years
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 monthsTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years
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: Time Frame: Baseline, every 3 months 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 studyTimepoint: Time Frame: Baseline, yearly up to 2.5 years
Secondary ID(s)
NCT02792218
COMB157G2301, Version number: 00,dated 7-Apr-2016
Source(s) of Monetary Support
Novartis Pharma AG Novartis Campus 4056 รข?? Basel,Switzerland
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 24/01/2017
Contact:
MS RAMAIAH MEDICAL COLLEGE AND HOSPITALS ETHICS COMMITTEE-Dr Srinivasa Rangasetty
Status: Approved
Approval date: 02/02/2017
Contact:
Institutional Ethics Committee-Prof Dheeraj khurana
Status: Approved
Approval date: 14/02/2017
Contact:
Max Healthcare Ethics Committee- Dr Joy Mukherji
Status: Approved
Approval date: 17/04/2017
Contact:
Institutional Ethics committee for human research- Dr SURESH KUMAR
Status: Approved
Approval date: 19/04/2017
Contact:
Central Ethics Committee Nitte University-Dr Lekha Pandit
Status: Approved
Approval date: 27/04/2017
Contact:
Sri Aurobindo Seva Kendra-Dr Pahari Ghosh
Status: Approved
Approval date: 29/04/2017
Contact:
Ethics Committee- Dr Joy Desai
Status: Not Approved
Approval date:
Contact:
Institute Ethics Committee- Dr Manjari Tripathi
Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee - Dr Usha kant Misra
Results
Results available:
Date Posted:
Date Completed:
URL:
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