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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

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Study Purpose

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

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 - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female participants aged 18 to 60 years (inclusive) at screening. 3. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as defined by (Lublin et al. 2014). 4. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive). 5. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1 course): • Participants currently treated with ocrelizumab must have received (meet all three criteria below): 1. 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600 mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infused ocrelizumab dose must have occurred within 4-9 months prior to baseline. •Participants currently treated with rituximab must have received (meet both criteria below): 1. At least 2 fully infused courses of rituximab 500 mg
  • - 1000 mg iv every 6 months (+/- one month).
1. Initial loading regimens of rituximab i.e. 500 mg
  • - 1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed by additional infusion(s) every 6 months (+/- one month) 2.
Last fully infused rituximab dose must have occurred within 4-9 months prior to baseline. 6. Participants discontinuing aCD20 therapy for reasons including, but not limited to: physician/participant preference, access to commercial drug (e.g. insurance coverage issues) or for other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study. 7. Neurologically stable within 1 month prior to first study drug administration. 8. Must be able to use a smart device or have a caregiver that can assist.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study: 1. Participants that have demonstrated suboptimal response to aCD20 therapy to include: a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newly enlarging T2 lesions, documented within the past 6 months.
  • - If a prior MRI within the last 6 months is not available, then new or newly enlarging T2 lesions should be considered "not documented" and the patient may continue screening b.
Documented relapse while on stable, previous aCD20 treatment.
  • - Relapses during the first 3 months of intravenous aCD20 therapy are allowable if the participant is then relapse-free for the 12 months following the relapse while on intravenous aCD20 therapy c.
Any signs of clinical worsening as measured by EDSS or any clinical measure documented within the last 6 months. 2. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events: 1. Severe infusion-related reactions (Grade 3 or above) 2. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratory infections or the need for ≥ 2 courses of antibiotics since starting aCD20 therapy, if the Investigator believes this is related to therapy. 3. Decreased IgG requiring treatment with Intravenous immunoglobulin. 3. Participants with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014). 4. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015). 5. Pregnant or nursing (lactating) women. 6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 6 months after stopping study medication. 7. Participants with 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). 8. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS). 9. Participants with neurological symptoms consistent with PML or with confirmed PML. 10. Participants at risk of developing or having reactivation of syphilis or tuberculosis. 11. Participants at risk of developing or having reactivation of hepatitis. 12. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration. a. There is presently no contraindication for the use of an inactivated, viral-vector-or mRNA based Sars-CoV-2 vaccine in patients who are immunocompromised. However, different Sars-CoV-2 vaccines may have various mechanisms of action and different associated potential risks. Please review local prescribing information of any specific Sars-CoV-2 vaccine and comply with local prescribing information requirements for specific contra-indications and special warnings and precautions for use.

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.

NCT04486716
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsing Multiple Sclerosis
Additional Details

This is a single-arm multi-center, study in approximately 100 participants with relapsing multiple sclerosis who were previously treated with aCD20 mAb therapy. Eligible participants will receive open label ofatumumab 20 mg subcutaneous monthly for 12 months following initial loading regimen of 20 milligrams subcutaneous doses on Days 1, 7 and 14. Assessments will include but are not limited to Magnetic Resonance Imaging (MRI) assessed for quality by central reading center, multiple Patient Reported Outcome measurements and safety assessments. Participants that do not continue onto commercial ofatumumab or another therapy within one month of the End of Study Visit must continue into the safety Follow Up phase, consisting of every 3 month visits including B cell monitoring until they are able to start on commercial ofatumumab or switch to another therapy or until their B cells are repleted defined as a B cell concentration greater than the individual participant's baseline value or greater than the lower limit of normal. All participants will have a safety follow-up phone call at 30 days post study.

Arms & Interventions

Arms

Experimental: Ofatumumab

Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml) administered at baseline, Day 7, Day 14 and monthly thereafter

Interventions

Drug: - Ofatumumab

Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)

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.

Birmingham, Alabama

Status

Active, not recruiting

Address

Alabama Neurology Associates PC Suite 105

Birmingham, Alabama, 35209

Site Contact

[email protected]

1-888-669-6682

Ctr for Neurology and Spine, Phoenix, Arizona

Status

Active, not recruiting

Address

Ctr for Neurology and Spine

Phoenix, Arizona, 85018

Site Contact

[email protected]

1-888-669-6682

Encinitas, California

Status

Withdrawn

Address

The Research Center of Southern California .

Encinitas, California, 92024

Site Contact

[email protected]

1-888-669-6682

La Jolla, California

Status

Withdrawn

Address

University of California San Diego UCSD ACTRI

La Jolla, California, 92037

Site Contact

[email protected]

1-888-669-6682

Neuro Center, Pomona, California

Status

Recruiting

Address

Neuro Center

Pomona, California, 91767

Site Contact

[email protected]

909-267-7495

Lightship, Torrance, California

Status

Withdrawn

Address

Lightship

Torrance, California, 90505

Site Contact

[email protected]

1-888-669-6682

UC Health Neuroscience Ctr, Aurora, Colorado

Status

Active, not recruiting

Address

UC Health Neuroscience Ctr

Aurora, Colorado, 80045

Site Contact

[email protected]

1-888-669-6682

Infinity Clinical Research LLC, Hollywood, Florida

Status

Completed

Address

Infinity Clinical Research LLC

Hollywood, Florida, 33024

Site Contact

[email protected]

1-888-669-6682

Neurology Associates of Ormond Beach, Ormond Beach, Florida

Status

Withdrawn

Address

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174

Site Contact

[email protected]

1-888-669-6682

University of South Florida ., Tampa, Florida

Status

Active, not recruiting

Address

University of South Florida .

Tampa, Florida, 33612

Site Contact

[email protected]

1-888-669-6682

International Neurorehab Institute, Lutherville, Maryland

Status

Active, not recruiting

Address

International Neurorehab Institute

Lutherville, Maryland, 21093

Site Contact

[email protected]

1-888-669-6682

Beth Israel Deaconess Medical Cente, Boston, Massachusetts

Status

Active, not recruiting

Address

Beth Israel Deaconess Medical Cente

Boston, Massachusetts, 02215

Site Contact

[email protected]

1-888-669-6682

Neurology Center of New England PC ., Foxboro, Massachusetts

Status

Active, not recruiting

Address

Neurology Center of New England PC .

Foxboro, Massachusetts, 02035

Site Contact

[email protected]

1-888-669-6682

Minnesota Center Multiple Sclerosis, Plymouth, Minnesota

Status

Active, not recruiting

Address

Minnesota Center Multiple Sclerosis

Plymouth, Minnesota, 55446

Site Contact

[email protected]

1-888-669-6682

Cleveland Clinic Foundation, Las Vegas, Nevada

Status

Active, not recruiting

Address

Cleveland Clinic Foundation

Las Vegas, Nevada, 89106

Site Contact

[email protected]

1-888-669-6682

Ms Ctr Of Northeastern Ny, Latham, New York

Status

Completed

Address

Ms Ctr Of Northeastern Ny

Latham, New York, 12110

Site Contact

[email protected]

1-888-669-6682

Novartis Investigative Site, Canton, Ohio

Status

Withdrawn

Address

Novartis Investigative Site

Canton, Ohio, 44718

Site Contact

[email protected]

1-888-669-6682

Westerville, Ohio

Status

Completed

Address

Columbus Neuroscience Columbus Neuroscience LLC

Westerville, Ohio, 43082

Site Contact

[email protected]

1-888-669-6682

Hope Neurology ., Knoxville, Tennessee

Status

Active, not recruiting

Address

Hope Neurology .

Knoxville, Tennessee, 37922

Site Contact

[email protected]

1-888-669-6682

Parkland Health and Hospital Systems, Dallas, Texas

Status

Active, not recruiting

Address

Parkland Health and Hospital Systems

Dallas, Texas, 75325

Site Contact

[email protected]

1-888-669-6682

Round Rock, Texas

Status

Completed

Address

Central Texas Neurology Consultants P A .

Round Rock, Texas, 78681

Site Contact

[email protected]

1-888-669-6682

Swedish Neuroscience Institute MS Center, Seattle, Washington

Status

Active, not recruiting

Address

Swedish Neuroscience Institute MS Center

Seattle, Washington, 98122

Site Contact

[email protected]

1-888-669-6682

International Sites

Guaynabo, Puerto Rico

Status

Active, not recruiting

Address

Caribbean Center for Clinical Research, Inc. .

Guaynabo, , 00968

Site Contact

[email protected]

1-888-669-6682

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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