Main
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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:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2017/03/008181 |
Date of registration:
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22-03-2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety of ofatumumab compared to teriflunomide in
patients with relapsing multiple sclerosis
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Scientific title:
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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:
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04-04-2017 |
Target sample size:
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900 |
Recruitment status: |
Closed to Recruitment of Participants |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16236 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Bulgaria
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Canada
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Chile
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Croatia
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Czech Republic
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Denmark
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Estonia
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France
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Germany
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Greece
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Hungary
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India
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Israel
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Italy
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Kuwait
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Mexico
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Saudi Arabia
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Slovakia
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Spain
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Sweden
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Switzerland
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Thailand
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Turkey
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United Kingdom
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United States of America
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Contacts
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Name:
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Murugananthan K
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Address:
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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:
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912224958545 |
Email:
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murugananthan.k@novartis.com |
Affiliation:
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Novartis Healthcare Pvt. Ltd |
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Name:
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Murugananthan K
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Address:
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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:
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912224958545 |
Email:
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murugananthan.k@novartis.com |
Affiliation:
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Novartis Healthcare Pvt. Ltd |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Relapsing Multiple Sclerosis
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Intervention(s)
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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)
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Primary Outcome(s)
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Annualized relapse rate (ARR)Timepoint: Time Frame: up to 2.5 years
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Secondary Outcome(s)
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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
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Time to 3-month confirmed disability worsening on EDSSTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years
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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
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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
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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
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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
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Secondary ID(s)
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NCT02792218
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COMB157G2301, Version number: 00,dated 7-Apr-2016
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Source(s) of Monetary Support
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Novartis Pharma AG Novartis Campus 4056 รข?? Basel,Switzerland
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Ethics review
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Status: Approved
Approval date: 24/01/2017
Contact:
MS RAMAIAH MEDICAL COLLEGE AND HOSPITALS ETHICS COMMITTEE-Dr Srinivasa Rangasetty
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Status: Approved
Approval date: 02/02/2017
Contact:
Institutional Ethics Committee-Prof Dheeraj khurana
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Status: Approved
Approval date: 14/02/2017
Contact:
Max Healthcare Ethics Committee- Dr Joy Mukherji
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Status: Approved
Approval date: 17/04/2017
Contact:
Institutional Ethics committee for human research- Dr SURESH KUMAR
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Status: Approved
Approval date: 19/04/2017
Contact:
Central Ethics Committee Nitte University-Dr Lekha Pandit
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Status: Approved
Approval date: 27/04/2017
Contact:
Sri Aurobindo Seva Kendra-Dr Pahari Ghosh
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Status: Approved
Approval date: 29/04/2017
Contact:
Ethics Committee- Dr Joy Desai
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Status: Not Approved
Approval date:
Contact:
Institute Ethics Committee- Dr Manjari Tripathi
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee - Dr Usha kant Misra
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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