A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
Study Evaluates Ofatumumab for Relapsing Multiple Sclerosis
Plain English Summary
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab is a Phase 3 clinical trial sponsored by Novartis Pharmaceuticals studying Relapsing Multiple Sclerosis. Tests Ofatumumab's effectiveness in treating relapsing multiple sclerosis (RMS) in patients transitioning from fumarate-based therapies or fingolimod. For patients with RMS who have experienced breakthrough disease while on fumarates or fingolimod. Participation involves receiving Ofatumumab injections and reporting on symptoms and side effects. Alternative treatments include other DMTs like dimethyl fumarate, diroximel fumarate, or fingolimod. The trial aims to enroll 562 participants.
Official Summary
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if diagnosed with MS, RMS, EDSS score 0-4, and have had breakthrough disease while on fumarates or fingolimod. Not eligible if have primary progressive MS, neuromyelitis optica, or active chronic diseases. Age range not specified, but must be neurologically stable within one month of starting the study. Must be transitioning from fumarate-based RMS therapies or fingolimod and have used them for at least 6 months. This trial is studying Relapsing Multiple Sclerosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the annualized relapse rate, which helps patients understand how often they might have relapses while on the treatment. The specific primary outcome measures are: Annualized Relapse Rate (ARR) (Up to 96 weeks from baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a treatment gap for RMS patients who have experienced breakthrough disease while on fumarates or fingolimod. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Relapsing Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
The market for MS treatments is large, with many competitors, but this trial could potentially lead to approval and new treatment options. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 562 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you have had breakthrough disease while on fumarates or fingolimod. Participation involves regular injections and reporting on symptoms and side effects. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 562 participants
Interventions
- BIOLOGICAL: Ofatumumab — Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Primary Outcomes
- Annualized Relapse Rate (ARR) (Up to 96 weeks from baseline)
Secondary Outcomes
- Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of MS according to the 2017 Revised McDonald criteria * Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) * Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive) * MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT * Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration * Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions) * Neurologically stable within one month prior to first study drug administration Exclusion Criteria: * Subjects with primary progressive MS or SPMS without disease activity * Subjects meeting criteria for neuromyelitis optica * Disease duration of more than 10 years since diagnosis * Pregnant or nursing (lactating) women * Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication * Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome * Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS) * Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML * Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice * Subjects with active hepatitis B and C disease, assessed locally * Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration * Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.) * Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator
Trial Locations
- Fullerton Neuro and Headache Ctr, Fullerton, California, United States
- CU Anschutz Med Campus, Aurora, Colorado, United States
- Christiana Care Health Services, Newark, Delaware, United States
- Memorial Healthcare System, Hollywood, Florida, United States
- Homestead Assoc In Research Inc, Homestead, Florida, United States
- Neurology Associates PA, Maitland, Florida, United States
- UM Department Of Neurology, Miami, Florida, United States
- Negroski Neurology, Sarasota, Florida, United States
- Axiom Clinical Research of Florida, Tampa, Florida, United States
- University Of South Florida, Tampa, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT04353492?
NCT04353492 is a Phase 3 INTERVENTIONAL study titled "An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab." It is currently completed and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 562 participants.
What conditions does NCT04353492 study?
This trial investigates treatments for Relapsing Multiple Sclerosis. The primary condition under study is Relapsing Multiple Sclerosis.
What treatments are being tested in NCT04353492?
The interventions being studied include: Ofatumumab (BIOLOGICAL). Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
What does Phase 3 mean for NCT04353492?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT04353492?
This trial is currently "Completed." It started on 2020-07-14. The estimated completion date is 2025-03-11.
Who is sponsoring NCT04353492?
NCT04353492 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04353492?
The trial aims to enroll 562 participants. The trial status is completed.
How is NCT04353492 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04353492?
The primary outcome measures are: Annualized Relapse Rate (ARR) (Up to 96 weeks from baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04353492 being conducted?
This trial is being conducted at 20 sites, including Fullerton, California; Aurora, Colorado; Newark, Delaware; Hollywood, Florida and 16 more sites (United States).
Where can I find official information about NCT04353492?
The official record for NCT04353492 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04353492. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04353492 testing in simple terms?
Tests Ofatumumab's effectiveness in treating relapsing multiple sclerosis (RMS) in patients transitioning from fumarate-based therapies or fingolimod. For patients with RMS who have experienced breakthrough disease while on fumarates or fingolimod.
Why is this trial significant?
This trial addresses a treatment gap for RMS patients who have experienced breakthrough disease while on fumarates or fingolimod. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT04353492?
Key risks include potential side effects from Ofatumumab, such as infections and allergic reactions. Monitor for any signs of neurological symptoms or infections and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04353492?
Ask your doctor if you have had breakthrough disease while on fumarates or fingolimod. Participation involves regular injections and reporting on symptoms and side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04353492 signal from an investment perspective?
The market for MS treatments is large, with many competitors, but this trial could potentially lead to approval and new treatment options. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving Ofatumumab injections and reporting on symptoms and side effects. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.