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Multiple Sclerosis clinical trials

View clinical trials related to Multiple Sclerosis.

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NCT ID: NCT05090371 Not yet recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

SOSTOS
Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

NCT ID: NCT05090033 Not yet recruiting - Clinical trials for Relapsing Multiple Sclerosis

Characterizing the Use of Ofatumumab in a Real World Setting

EAFToS
Start date: November 1, 2021
Phase:
Study type: Observational

This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.

NCT ID: NCT05088473 Not yet recruiting - Multiple Sclerosis Clinical Trials

Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases

Start date: October 15, 2021
Phase:
Study type: Observational

Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.

NCT ID: NCT05084638 Not yet recruiting - Clinical trials for Relapse Remitting Multiple Sclerosis

Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

AGNOS
Start date: November 5, 2021
Phase: Phase 4
Study type: Interventional

This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.

NCT ID: NCT05083923 Not yet recruiting - Clinical trials for Relapsing Forms of Multiple Sclerosis

A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

Start date: November 19, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).

NCT ID: NCT05081700 Recruiting - Multiple Sclerosis Clinical Trials

A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

Start date: May 11, 2020
Phase:
Study type: Observational

This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease activity. Identification of such biomarkers could have an immediate clinical utility in identification of MS patients prone to more aggressive disease earlier in their disease course, thus affording the opportunity to better individualize therapy. In addition, insights from better understanding of the complex interplay of various systems biology factors should improve our understanding of MS in general. The study will recruit 50 patients with relapsing MS who are initiating treatment with ocrelizumab, and follow them for 15 months, with an optional extension phase up to 24 months, using a suite of clinical, para-clinical and biological assessments. After 75% of the patients have completed 12 months, analysis will be conducted and reported to Roche/Genentech, to determine whether to pursue the extension phase.

NCT ID: NCT05081271 Not yet recruiting - Clinical trials for PWMS Who Have Completed Vaccination Against COVID-19 and Test Negative for COVID-19 Spike Protein Antibodies Using a Commercial Assay

COVID-19 Booster Vaccination in Persons With Multiple Sclerosis

Start date: October 2021
Phase: N/A
Study type: Interventional

A. Purpose / Rationale The success of the United States vaccination program against SARS-Cov-2 is shown by the dramatic drop in infection rates, hospitalizations and deaths1.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination2, 3,4. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is not clear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is away to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.

NCT ID: NCT05080270 Completed - Multiple Sclerosis Clinical Trials

Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis

MSFibroblast
Start date: September 21, 2020
Phase: Early Phase 1
Study type: Interventional

Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS). Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.

NCT ID: NCT05078177 Recruiting - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis

Start date: December 21, 2020
Phase: Phase 1
Study type: Interventional

Considering the accumulated data on the pathogenesis of multiple sclerosis, indicating a significant role of B cells in the progression of the disease, the use of monoclonal antibodies to CD20 antigen, administered intrathecally to achieve adequate B-lymphodepletion in the barrier tissues can increase the duration of the recurrence-free course of autoimmune diseases, suspend their progression, and also prevent clinical relapse when memory B cells are detected.

NCT ID: NCT05077956 Not yet recruiting - Multiple Sclerosis Clinical Trials

Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis

Sema4A MS
Start date: October 25, 2021
Phase:
Study type: Observational

Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).