HomeSteward Multiple Sclerosis

Clinical Trials

Access to the latest research treatments

Clinical trials, also known as clinical studies, are one of the most effective ways that doctors are able to improve health care. These studies look at new ways of treating diseases or conditions, such as multiple sclerosis, as well as examining new combinations of existing drugs. While these trials are a necessary step on a new medication's road to public availability, they can also help patients who participate by providing them with the first benefits of a new approach or medication.

St. Elizabeth's Medical Center is the only Steward Health Care location to offer clinical trials for multiple sclerosis patients.

For more information, contact Marissa Hone, Research Coordinator, at Marissa.Hone@steward.org.

Currently Recruiting Clinical Trials

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects with Secondary Progressive Multiple Sclerosis (ASCEND)

Purpose: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS.

Population: Secondary Progressive MS

Sponsor: Biogen Idec

Click here for more information


A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate The Efficacy and Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis (OPERA)

Purpose: The primary objective of this study is to assess whether the efficacy of ocrelizumab 600 mg intravenously every 24 weeks is superior to Rebif® as measured by the annualized protocol-defined relapse rate by two years in patients with relapsing multiple sclerosis.

Population: Relapsing Remitting MS

Sponsor: F. Hoffman La-Roche and Genentech, Inc

Click here for more information


A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of TcelnaTM in Subjects with Secondary Progressive Multiple Sclerosis

Purpose: This will be a Phase 2, multi-center, randomized (1:1), double-blind, placebo-controlled, 2-arm, 2-year, parallel-group study of Tcelna versus placebo in 180 in subjects with SPMS with or without superimposed clinical relapses in the preceding two years.

Population: Secondary Progressive MS

Sponsor: Opexa Therapeutics


A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients (STRIVE)

Purpose: The primary objective of the study is to determine which baseline and yearly response factors predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The response factors include clinical assessments of sustained EDSS progression, relapse status, and MRI measures, and patient reported outcomes of cognition, capacity to work, quality of life and visual function assessments.

Population: Relapsing Remitting MS

Sponsor: Biogen Idec

Click here for more information


Long-term, prospective, observational, multinational, parallel-cohort study monitoring safety in patients with MS newly started with fingolimod once daily or treated with another approved disease-modifying therapy (PASSAGE)

Purpose: To investigate the incidence of selected safety outcomes in the target population that newly receives fingolimod according to the approved product label.

Population: Relapsing Remitting MS

Sponsor: Novartis

Click here for more information


A Prospective, Open-Label, Non-Controlled Clinical Trial to Describe the Use, Effectiveness, and Safety of Teriflunomide in Routine Clinical Practice

Purpose: The primary objective of this study is to evaluate teriflunomide treatment in the routine clinical setting from the patient’s perspective.

Population: RRMS patients


A two-year observational study to evaluate the safety profile of fingolimod in patients with multiple sclerosis who switch from natalizumab to fingolimod (TRANSITION)

Purpose: The purpose of this world-wide prospective observational single-cohort study is to evaluate, over a period of two years, the overall safety profile of fingolimod as well as the incidence of selected safety outcomes in patients previously exposed to natalizumab under the conditions of routine medical practice.

Population: RRMS patients


Active Clinical Trials That Are Closed to Enrollment of New Patients

Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Purpose: This study is being conducted to determine the superiority of DAC HYP compared to IFN β-1a in preventing MS relapse in subjects with relapsing remitting MS (RRMS) when DAC HYP 150mg is administered SC once every 4 weeks for 96 to 144 weeks as compared to a 30mg IM injection of Interferon β1a once weekly for 96 to 144 weeks.

Population: Relapsing Remitting MS

Sponsor: Biogen Idec

Click here for more information.


A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis (ENDORSE)

Purpose: The primary objective of the study is to evaluate the long-term safety profile of BG00012


Population:
Relapsing Remitting MS

Sponsor: Biogen Idec

Click here for more information.


JCV Antibody Program (STRATIFY-2)

Purpose: Define the sero prevalence of JCV Antibody in the MS population and potentially stratify patients into lower or higher risk for developing PML based on antibody status.

Population: All types of MS

Sponsor: Biogen Idec

Click here for more information.


An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Purpose: This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes of this study are:

  1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies.
  2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
  3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Population: Relapsing Remitting MS

Sponsor: Genzyme

Click here for more information.


TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World

Purpose: The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in patients with multiple sclerosis (MS) treated with TYSABRI® (natalizumab).

Population: All types of MS

Sponsor: Biogen Idec

Click here for more information.


FTY720 in Patients With Primary Progressive Multiple Sclerosis (INFORMS)

Purpose: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS.

Population: Primary Progressive MS

Sponsor: Novartis

Click here for more information.


Completed Studies

A 6-month, Randomized, Open-label, Patient Outcomes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis (EPOC)

The purpose of this study is to evaluate patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patient with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Population:Relapsing Remitting MS

Sponsor: Novartis

Click here for more information.


JCV Antibody Program (STRATIFY-1)

Purpose: Study conducted to define the prevalence of Serum JC Antibody in relapsing MS patients receiving Tysabri or being considered for such treatment. Analytically validate the JCV antibody assay in a plasma matrix.

Population: All types of MS

Sponsor: Biogen Idec

Click here for more information.


Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)

Purpose: To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Population: Relapsing Remitting MS

Sponsor: Biogen Idec

Click here for more information.


Treatment Interruption of Natalizumab (RESTORE)

Purpose: This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.

The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:

  • how quickly the effects that natalizumab has on the immune system disappear,
  • when MS symptoms return, and
  • if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.
  • This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.

Population: Relapsing Remitting MS

Sponsor: Biogen Idec

Click here for more information.


Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS II)

Purpose: This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

Population: Relapsing Remitting MS

Sponsor: Novartis

Click here for more information.


Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Visit Our YouTube Channel Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions