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: ClinicalTrials.gov Identifier: NCT02047097

This study is active, but closed to enrollment.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT02047097

This study is active, and open to enrollment for current study subjects.

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT03257358

This study is active, but closed to enrollment.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

NJCK 12-01

Prospective Evaluation of Hypofractionated Stereotactic Body Radiotherapy for High Risk Prostate Cancer

• Community Medical Center

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

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT03157830

This study is active and open to enrollment.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT01442194

This study is closed.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT02230969

This study is closed.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT03500328

This study is open to enrollment.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier: NCT03689972

This study is active, but closed to enrollment.

For inquiries, call (973) 322-7073

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center

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: ClinicalTrials.gov Identifier:

This study is active, and open for enrollment.

• Cooperman Barnabas Medical Center
• RWJBarnabas Health Ambulatory Care Center