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ESTEEM
- NCT02047097
This Phase IV study follows patients who are newly initiating dimethyl fumarate (Tecfidera) and monitors clinical effectiveness and the incidence of adverse events in routine clinical care.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is active, but closed to enrollment.
For inquiries, call (973) 322-7073
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ESTEEM KETONE SUB-STUDY
An additional sub-study (Ketone Sub- study) to ESTEEM is being offered to approximately 130 patients who are currently enrolled in ESTEEM at ~25 sites in the US in order to assess urine and serum ketones in DMF-treated patients. After enrollment in the sub-study, serum and urine will be collected at each routine visit to measure the serum and urine ketone levels.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is active, and open to enrollment for current study subjects.
For inquiries, call
(973) 322-7073
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FLUENT
- NCT03257358
This Phase IV study aims to characterize how certain immune biomarkers change for MS patients while they are receiving fingolimod (Gilenya) 0.5 mg/day.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is active, but closed to enrollment.
For inquiries, call (973) 322-7073
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IV Methylprednisolone for Progressive MS
This study aims to investigate the effectiveness of IV Methylprednisolone (IV MP) at 1g /day for 5 days v. sub-therapeutic doses of IV MP for 5 days in RMS, RRMS, and SPMS DMT-treated MS patients who are experiencing functional decline in the absence of relapses (progressive MS).
Type: Drug Trial
Principal Investigator: Andrew Sylvester, MD
This study is open to enrollment.
For inquiries, call (973) 322-7073
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NJCK 12-01
Prospective Evaluation of Hypofractionated Stereotactic Body Radiotherapy for High Risk Prostate Cancer
For inquiries, call
(732) 557-8294
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OCT Study
Evaluation of Immunomodulator Effects on Retinal Nerve Fiber Layer and Macular Volumes in People with Multiple Sclerosis using Ocular Coherence Tomography
Type: Retrospective Chart review
Principal Investigator: Matthew Tremblay, MD, PhD
Website: IRB Study 20-36
This study is a retrospective data review.
For inquiries, call
(973) 322-7073
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OCTAVE
- NCT03157830
The OCTAVE study is a phase IV study that follows RMS patients to assess the efficacy of ocrelizumab (Ocrevus) in patients who have been previously treated with natalizumab (Tysabri) by evaluating relapse rate, disease progression on MRI, and disability progression.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is active and open to enrollment.
For inquiries, call (973) 322-7073
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PASSAGE
- NCT01442194
This Phase IV study follows patients who start fingolimod (Gilenya) at time of study entry to monitor clinical effectiveness and the incidence of adverse events in routine clinical care. A parallel cohort for patients who started another DMT within six months prior to study entry has been filled and closed.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is closed.
For inquiries, call (973) 322-7073
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POP
- NCT02230969
This Phase IV study examines the long-term safety and effectiveness of peginterferon beta-1a (Plegridy) for MS patients, over approximately a five year time period. Information on side effects (for example, flu-like symptoms [FLS], injection site reactions [ISRs], and other serious side effects), relapses, disability progression, and the quality of life in patients taking Plegridy will be collected.
Type: Observational
Principal Investigator: Andrew Sylvester, MD
Website:
This study is closed.
For inquiries, call (973) 322-7073
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TREAT-MS
- NCT03500328
This study compares high efficacy vs. low efficacy DMT therapy for RRMS patients broken into low-risk and high-risk strata to determine the effectiveness of an early aggressive treatment approach on intermediate-term disease progression.
Type: Drug Trial
Principal Investigator: Matthew Tremblay, MD, PhD
Website:
This study is open to enrollment.
For inquiries, call (973) 322-7073
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Tysabri-Extended Dosing
- NCT03689972
The Phase III study aims to assess the efficacy, tolerability, and safety of switching to natalizumab (Tysabri) dosing interval of 6 weeks after at least 12 months of disease stability on (Tysabri) standard interval 4 week dosing in patients diagnosed with RRMS.
Type: Interventional
Principal Investigator: Andrew Sylvester, MD
Website:
This study is active, but closed to enrollment.
For inquiries, call (973) 322-7073
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VERISMO
This is a prospective, non-interventional, longitudinal, observational study of MS patients who have newly initiated treatment with ocrelizumab that is being conducted to determine the incidence and mortality rates of breast cancer and all malignancies.
Type: Observational
Principal Investigator: Matthew Tremblay, MD, PhD
Website:
This study is active, and open for enrollment.
For inquiries, call
(973) 322-7073