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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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).
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
  • - 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.
In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • - Male sterilization (at least 6 months prior to screening).
For female participants on the study, the vasectomized male partner should be the sole partner for that participant. (Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.)
  • - 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.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF. 8. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency) 9. Patients with an active infection (bacterial, fungal, or viral like hepatitis, HIV or COVID), until the infection is resolved. Where local regulation requires it, Sars-Cov-19 must be ruled out by the PCR test. 10. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML. 11. Positive results at Screening for serological markers for hepatitis (H) B and C indicating acute or chronic infection:
  • - Hepatitis B virus (HBV) screening should be performed before initiation of treatment.
At a minimum, screening should include hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) testing. These can be complemented with other appropriate markers as per local guidelines. Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
  • - 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.
In the case the patient has a record of vaccination including HB, and there is no evidence of acute or chronic hepatitis infection (confirmed by an infectious disease expert), the Investigator must document (in source data and as a comment in the electronic Case Report Form (eCRF) that the serology results are considered false positive and may then enroll the subject. 12. Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration. 13. Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures. 14. Any of the following conditions or treatments that may impact the safety of the patient:
  • - 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.
15. Any of the following abnormal laboratory values prior to first study drug administration:
  • - 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.
Patients with severe hypoproteinemia e.g. in nephrotic syndrome. 17. Patients with any of the following neurologic/psychiatric disorders prior to first study drug administration:
  • - 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.
18. History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes

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

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Nantes, Cedex 1, France

Status

Recruiting

Address

Novartis Investigative Site

Nantes, Cedex 1, 44093

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Amiens, France

Status

Recruiting

Address

Novartis Investigative Site

Amiens, , 80054

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Bordeaux Cedex, France

Status

Recruiting

Address

Novartis Investigative Site

Bordeaux Cedex, , 33076

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Clermont-Ferrand Cedex 1, France

Status

Recruiting

Address

Novartis Investigative Site

Clermont-Ferrand Cedex 1, , 63003

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Creteil, France

Status

Recruiting

Address

Novartis Investigative Site

Creteil, , 94010

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Gonesse, France

Status

Recruiting

Address

Novartis Investigative Site

Gonesse, , 95500

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Grenoble, France

Status

Recruiting

Address

Novartis Investigative Site

Grenoble, , 38042

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Lille, France

Status

Recruiting

Address

Novartis Investigative Site

Lille, , 59037

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Montpellier, France

Status

Recruiting

Address

Novartis Investigative Site

Montpellier, , 34295

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Nice, France

Status

Recruiting

Address

Novartis Investigative Site

Nice, , 06202

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Nimes, France

Status

Recruiting

Address

Novartis Investigative Site

Nimes, , 30029

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Poissy, France

Status

Recruiting

Address

Novartis Investigative Site

Poissy, , 78303

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Rennes Cedex, France

Status

Recruiting

Address

Novartis Investigative Site

Rennes Cedex, , 35033

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Strasbourg, France

Status

Recruiting

Address

Novartis Investigative Site

Strasbourg, , 67098

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Suresnes, France

Status

Recruiting

Address

Novartis Investigative Site

Suresnes, , 92150

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Bayreuth, Germany

Status

Recruiting

Address

Novartis Investigative Site

Bayreuth, , 95445

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 12101

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 13353

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Bielefeld, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Bielefeld, , 33647

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Dortmund, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dortmund, , 44137

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Erbach, Germany

Status

Recruiting

Address

Novartis Investigative Site

Erbach, , 64711

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Frankfurt, Germany

Status

Recruiting

Address

Novartis Investigative Site

Frankfurt, , 60590

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Heidelberg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Heidelberg, , 69120

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Kassel, Germany

Status

Withdrawn

Address

Novartis Investigative Site

Kassel, , 34121

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Koeln, Germany

Status

Recruiting

Address

Novartis Investigative Site

Koeln, , 50937

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Siegen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Siegen, , 57076

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Ulm, Germany

Status

Recruiting

Address

Novartis Investigative Site

Ulm, , 89073

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Ulm, Germany

Status

Withdrawn

Address

Novartis Investigative Site

Ulm, , 89081

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Westerstede Oldenburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Westerstede Oldenburg, , 26655

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Montichiari, BS, Italy

Status

Recruiting

Address

Novartis Investigative Site

Montichiari, BS, 25018

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Milano, MI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milano, MI, 20132

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Roma, RM, Italy

Status

Recruiting

Address

Novartis Investigative Site

Roma, RM, 00133

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Roma, RM, Italy

Status

Recruiting

Address

Novartis Investigative Site

Roma, RM, 00189

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Orbassano, TO, Italy

Status

Recruiting

Address

Novartis Investigative Site

Orbassano, TO, 10043

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Napoli, Italy

Status

Recruiting

Address

Novartis Investigative Site

Napoli, , 80131

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Malaga, Andalucia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Malaga, Andalucia, 29010

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Sevilla, Andalucia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Sevilla, Andalucia, 41009

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Salt, Cataluna, Spain

Status

Recruiting

Address

Novartis Investigative Site

Salt, Cataluna, 17190

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Santiago De Compostela, Galicia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Santiago De Compostela, Galicia, 15706

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, El Palmar, Murcia, Spain

Status

Recruiting

Address

Novartis Investigative Site

El Palmar, Murcia, 30120

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Baracaldo, Vizcaya, Spain

Status

Recruiting

Address

Novartis Investigative Site

Baracaldo, Vizcaya, 48903

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08035

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28009

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28034

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28040

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Valencia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valencia, , 46026

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Zaragoza, Spain

Status

Withdrawn

Address

Novartis Investigative Site

Zaragoza, , 50009

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Exeter, United Kingdom

Status

Withdrawn

Address

Novartis Investigative Site

Exeter, , EX2 5DW

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Glasgow, United Kingdom

Status

Withdrawn

Address

Novartis Investigative Site

Glasgow, , G51 4TF

Site Contact

[email protected]

+41613241111

Resources

Clinical Trials in MS


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