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Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS
Study Purpose
This study will compare ofatumumab vs.#46; European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 55 Years |
Gender | All |
More Inclusion & Exclusion Criteria
Inclusion Criteria. 1. Written informed consent obtained before any assessment. 2. Male/female patients, 18 through 55 (inclusive) years of age. 3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018). 4. Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014. 5. Treatment Naïve patients, ≤ 5 years since first MS symptom. 6. EDSS score 0-4.0 (inclusive). 7. Patient must be suitable to be treated with one of first line self-administered DMT-physician's choice (glatiramer acetate, IFNs, teriflunomide, DMF, diroximel fumarate according to EMA SmPC) or ofatumumab depending on randomization and physician's choice. 8. At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening. 9. Able to obtain MRI assessment. 10. Neurologically stable within 1 month prior to first study drug administration Exclusion Criteria. 1. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation. 2. Progressive MS phenotypes: Patients with primary progressive MS (Polman et al 2011) or SPMS (Lublin et al 2014). 3. Use of other experimental or investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or 5 elimination half-lives, or until the expected pharmacodynamics effect has returned to baseline, whichever is longer. 4. Relapse between Screening and Baseline visits. 5. Pregnancy or breastfeeding. 6. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator. 7. Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC. Highly effective methods of contraception include:
- - Total abstinence (when this is in line with the preferred and usual lifestyle of the participant).
- - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment.
- - Male sterilization (at least 6 months prior to screening).
- - Use of combined, estrogen and progesterone containing (oral, intravaginal, transdermal), hormonal methods of contraception or use of progesterone-only (oral, injectable, implantable) hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- - Hepatitis B virus (HBV) screening should be performed before initiation of treatment.
- - Hepatitis C risk must be ruled out via anti-HC IgG (if positive IgG, HCV-RNA PCR will be performed and if negative, patient can be enrolled) NOTE: If the Investigator suspects false positive hepatitis serology results such as an antibody pattern indicating acute hepatitis infection but no corresponding elevated liver enzymes and no signs or symptoms of liver disease, an infectious disease expert may be consulted.
- - History of, or current, significant cardiac disease including cardiac failure (NYHA functional class II-IV), myocardial infarction (within 6 months prior to screening), unstable angina (within 6 months prior to screening), transient ischemic attack (within 6 months prior to screening), stroke, cardiac arrhythmias requiring treatment or uncontrolled arterial hypertension.
- - Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia and clinically significant second or third degree AV block without a pacemaker on screening electrocardiogram (ECG) - History of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis.
- - Patients with asthma requiring regular treatment with oral steroids.
- - Severe hepatic impairment (Child-Pugh class C) or any chronic liver or biliary disease.
- - Patients with severe renal impairment (glomerular filtration rate < 30 ml/min/1.73 m2) - Any medically unstable condition as determined by the Investigator.
- - Total bilirubin greater than 3 times upper limit of normal (ULN) range, unless in the context of Gilbert's syndrome.
- - Alkaline phosphatase (ALP) greater than 5 times the ULN range.
- - Serum IgG < 500mg/dL (according to central laboratory range) - Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function) 16.
- - Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the Columbia- Suicide Severity Rating Scale (CSSRS) if this ideation occurred in the past 6 months OR.
- - "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self- Injurious Behavior" (item also included in the Suicidal Behavior section) if this behavior occurred in the past 2 years.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04788615 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Novartis Pharmaceuticals |
Principal Investigator Affiliation | Novartis Pharmaceuticals |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | France, Germany, Italy, Spain, United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Additional Details
The study is a randomized (1:1), open-label, rater-blind, multi-center, prospective, parallel-arm, active comparator study which will consist of 15 months treatment period and a 6 months observational safety extension period, for patients who withdraw ofatumumab for any reason, in 186 total patients with early relapsing multiple sclerosis (RMS) RMS patients are patients who are newly diagnosed or have never been on active treatment at the time of study entry with ≤ 5 years from first MS symptoms. There is a screening period and patients are randomized to either ofatumumab or first line DMT at baseline. Patients will be treated until the end of study (EOS) or for a maximum duration of 15 months. Patients who prematurely discontinue study drug or comparator will have their end of treatment (EOT) visit and assessments at the time of discontinuation. After ofatumumab or the standard of care comparator (DMT) discontinuation, patients may initiate alternative MS therapy according to local standard of care, if clinically indicated. Patients who for any reason withdraw from ofatumumab during treatment will be invited to participate in the observational extension safety period for 6 months or until patient re-starts MS treatment with a new DMT treatment. During this period, clinical efficacy after ofatumumab withdrawal will be assessed.
Arms & Interventions
Arms
Experimental: ofatumumab
Oftatumumab 20mg auto injector syringes for subcutaneous injection on Day 1, Week 1 and 2, followed by subsequent monthly dosing, starting at Month 1.
Active Comparator: First line DMT
Glatiramer acetate minimum dose 20mg or maximum dose 40mg twice a day or three times a week or Interferon minimum dose 22µg or maximum dose of 0.25mg 3 times a week or once a week or Every second week depending on preparation or Peg-Interferon beta-1a minimum dose of 63µg or maximum dose of 125µg every 2 weeks (14 days) or Teriflunomide 14 mg once a day or Dimethyl fumarate minimum dose of 120mg or maximum dose of 240mg twice a day Diroximel fumarate minimum dose of 231mg or maximum dose of 462mg twice a day
Interventions
Drug: - Ofatumumab
20mg Subcutaneous injection
Drug: - First line DMT
any one of these based on availability at country given as First line DMT Glatiramer acetate 20mg or 40mg or Interferon 22µg or 0.25mg or Peg-Interferon beta-1a 63µg or 125µg or Teriflunomide 14mg or Dimethyl fumarate 120mg or 240mg or Diroximel fumarate 231mg or 462mg
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Novartis Investigative Site, Bayonne, Bayonne Cedex, France
Status
Recruiting
Address
Novartis Investigative Site
Bayonne, Bayonne Cedex, 64109
Novartis Investigative Site, Nantes, Cedex 1, France
Status
Recruiting
Address
Novartis Investigative Site
Nantes, Cedex 1, 44093
Novartis Investigative Site, Amiens, France
Status
Recruiting
Address
Novartis Investigative Site
Amiens, , 80054
Novartis Investigative Site, Bordeaux Cedex, France
Status
Recruiting
Address
Novartis Investigative Site
Bordeaux Cedex, , 33076
Novartis Investigative Site, Clermont-Ferrand Cedex 1, France
Status
Recruiting
Address
Novartis Investigative Site
Clermont-Ferrand Cedex 1, , 63003
Novartis Investigative Site, Creteil, France
Status
Recruiting
Address
Novartis Investigative Site
Creteil, , 94010
Novartis Investigative Site, Gonesse, France
Status
Recruiting
Address
Novartis Investigative Site
Gonesse, , 95500
Novartis Investigative Site, Grenoble, France
Status
Recruiting
Address
Novartis Investigative Site
Grenoble, , 38042
Novartis Investigative Site, Lille, France
Status
Recruiting
Address
Novartis Investigative Site
Lille, , 59037
Novartis Investigative Site, Montpellier, France
Status
Recruiting
Address
Novartis Investigative Site
Montpellier, , 34295
Novartis Investigative Site, Nice, France
Status
Recruiting
Address
Novartis Investigative Site
Nice, , 06202
Novartis Investigative Site, Nimes, France
Status
Recruiting
Address
Novartis Investigative Site
Nimes, , 30029
Novartis Investigative Site, Poissy, France
Status
Recruiting
Address
Novartis Investigative Site
Poissy, , 78303
Novartis Investigative Site, Rennes Cedex, France
Status
Recruiting
Address
Novartis Investigative Site
Rennes Cedex, , 35033
Novartis Investigative Site, Strasbourg, France
Status
Recruiting
Address
Novartis Investigative Site
Strasbourg, , 67098
Novartis Investigative Site, Suresnes, France
Status
Recruiting
Address
Novartis Investigative Site
Suresnes, , 92150
Novartis Investigative Site, Bayreuth, Germany
Status
Recruiting
Address
Novartis Investigative Site
Bayreuth, , 95445
Novartis Investigative Site, Berlin, Germany
Status
Recruiting
Address
Novartis Investigative Site
Berlin, , 12101
Novartis Investigative Site, Berlin, Germany
Status
Recruiting
Address
Novartis Investigative Site
Berlin, , 13353
Novartis Investigative Site, Bielefeld, Germany
Status
Active, not recruiting
Address
Novartis Investigative Site
Bielefeld, , 33647
Novartis Investigative Site, Dortmund, Germany
Status
Recruiting
Address
Novartis Investigative Site
Dortmund, , 44137
Novartis Investigative Site, Erbach, Germany
Status
Recruiting
Address
Novartis Investigative Site
Erbach, , 64711
Novartis Investigative Site, Frankfurt, Germany
Status
Recruiting
Address
Novartis Investigative Site
Frankfurt, , 60590
Novartis Investigative Site, Heidelberg, Germany
Status
Recruiting
Address
Novartis Investigative Site
Heidelberg, , 69120
Novartis Investigative Site, Kassel, Germany
Status
Withdrawn
Address
Novartis Investigative Site
Kassel, , 34121
Novartis Investigative Site, Koeln, Germany
Status
Recruiting
Address
Novartis Investigative Site
Koeln, , 50937
Novartis Investigative Site, Siegen, Germany
Status
Recruiting
Address
Novartis Investigative Site
Siegen, , 57076
Novartis Investigative Site, Ulm, Germany
Status
Recruiting
Address
Novartis Investigative Site
Ulm, , 89073
Novartis Investigative Site, Ulm, Germany
Status
Withdrawn
Address
Novartis Investigative Site
Ulm, , 89081
Novartis Investigative Site, Westerstede Oldenburg, Germany
Status
Recruiting
Address
Novartis Investigative Site
Westerstede Oldenburg, , 26655
Novartis Investigative Site, Montichiari, BS, Italy
Status
Recruiting
Address
Novartis Investigative Site
Montichiari, BS, 25018
Novartis Investigative Site, Milano, MI, Italy
Status
Recruiting
Address
Novartis Investigative Site
Milano, MI, 20132
Novartis Investigative Site, Roma, RM, Italy
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site, Roma, RM, Italy
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site, Orbassano, TO, Italy
Status
Recruiting
Address
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site, Napoli, Italy
Status
Recruiting
Address
Novartis Investigative Site
Napoli, , 80131
Novartis Investigative Site, Malaga, Andalucia, Spain
Status
Recruiting
Address
Novartis Investigative Site
Malaga, Andalucia, 29010
Novartis Investigative Site, Sevilla, Andalucia, Spain
Status
Recruiting
Address
Novartis Investigative Site
Sevilla, Andalucia, 41009
Novartis Investigative Site, Salt, Cataluna, Spain
Status
Recruiting
Address
Novartis Investigative Site
Salt, Cataluna, 17190
Novartis Investigative Site, Santiago De Compostela, Galicia, Spain
Status
Recruiting
Address
Novartis Investigative Site
Santiago De Compostela, Galicia, 15706
Novartis Investigative Site, El Palmar, Murcia, Spain
Status
Recruiting
Address
Novartis Investigative Site
El Palmar, Murcia, 30120
Novartis Investigative Site, Baracaldo, Vizcaya, Spain
Status
Recruiting
Address
Novartis Investigative Site
Baracaldo, Vizcaya, 48903
Novartis Investigative Site, Barcelona, Spain
Status
Recruiting
Address
Novartis Investigative Site
Barcelona, , 08035
Novartis Investigative Site, Madrid, Spain
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 28009
Novartis Investigative Site, Madrid, Spain
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 28034
Novartis Investigative Site, Madrid, Spain
Status
Recruiting
Address
Novartis Investigative Site
Madrid, , 28040
Novartis Investigative Site, Valencia, Spain
Status
Recruiting
Address
Novartis Investigative Site
Valencia, , 46026
Novartis Investigative Site, Zaragoza, Spain
Status
Withdrawn
Address
Novartis Investigative Site
Zaragoza, , 50009
Novartis Investigative Site, Exeter, United Kingdom
Status
Withdrawn
Address
Novartis Investigative Site
Exeter, , EX2 5DW
Novartis Investigative Site, Glasgow, United Kingdom
Status
Withdrawn
Address
Novartis Investigative Site
Glasgow, , G51 4TF
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