MULTIPLE SCLEROSIS RESEARCH STUDIES

Dr. Yelena Usmanova is involved in numerous research trials related to advances in the treatment of Multiple Sclerosis.

WA21092 (“Opera”)

Study Overview

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

Study Duration–96 Weeks

Phase-III

Enrollment Closed

Principle Investigator

Jessica Stulc, MD

Sponsor

F.Hoffmann-La Roche Ltd

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

109MS401 (“ESTEEM”)

Study Overview

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis.

Principle Investigator

Jessica Stulc, MD

Sponsor

Biogen Idec

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

Protocol No.:  CLR_09_21

Study Overview

A Placebo-Controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects with Spasticity Due to Multiple Sclerosis.

Principle Investigator

Jessica Stulc, MD

Sponsor

Sun Pharmaceuticals

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

105MS401 (“POP”)

Study Overview

Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program.

Principle Investigator

Jessica Stulc, MD

Sponsor

Biogen Idec

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

TV5600-CNS-200006: ARPEGGIO 

Study Overview

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis.

Principle Investigator

Jessica Stulc, MD

Sponsor

Teva Pharmaceuticals

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

OBS14527 Sanofi/Genzyme “LEM-COG”:

A Prospective 24-Month Observational Study to Evaluate Neurocognitive Function and Safety in Patients with Relapsing Multiple Sclerosis Who Are Initiating LEMTRADA® Treatment in Routine Clinical Practice.  Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

MA30143 “ENSEMBLE”:

An open-label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

MN30035 “CHORDS”:

An open-label study to evaluate the effectiveness and safety of Ocrelizumab in patients with relapsing remitting multiple sclerosis who have had a suboptimal response to an adequate course of disease-modifying treatment. Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

COMB157G2302 “ASCLEPIOS” :

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

OBS13434 Sanofi/Genzyme “PASS”:

A PROSPECTIVE, MULTICENTER, OBSERVATIONAL POST-AUTHORIZATION SAFETY STUDY TO EVALUATE THE LONG TERM SAFETY PROFILE OF LEMTRADA® (ALEMTUZUMAB) TREATMENT IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

205MS305 BiogenSUSTAIN

A PHASE 3B, 12-MONTH, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIIB019, DACLIZUMAB HIGH YIELD PROCESS (DAC HYP) IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS SWITCHING FROM NATALIZUMAB. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

OBS14448 Sanofi/Genzyme “PRO-ACT”:

A Prospective, 24-Month Observational Study to Evaluate Patient Reported Outcomes and Safety After LEMTRADA® Treatment In Patients With Relapsing Multiple Sclerosis Switching From A Prior Disease Modifying Therapy.  Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

CFTY720D2403 Novartis “PASSAGE

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated  with another approved disease-modifying therapy. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

109MS401 Biogen Idec “ESTEEM”

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM). Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Nichole Cope (Clinical Research Coordinator) at 763-302-4126.

DWA21092 Roche “OPERA”

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 (96 weeks). Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

CBAF312A2304 Novartis “EXPAND”

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

RPC01-3001 Receptos “DAYBREAK”

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

BN29739 Roche/Genzyme “VELOCE”

A PHASE IIIB, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE EFFECTS OF OCRELIZUMAB ON IMMUNE RESPONSES IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS. Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

AMS04

(DAIT), (NIAID), (NIH) Mechanistic Studies of Phase III Trial with BAF312 in Secondary Progressive Multiple Sclerosis. Enrollment closed                                                                       

Principle Investigator

Jonathan Calkwood, M.D.                                     

OBS14379 Sanofi/Genzyme “Infusion Vital Signs Study”:

A prospective observational cohort study in adult patients with relapsing multiple sclerosis to assess patient safety during and after LEMTRADA® (alemtuzumab) infusions of the first treatment course.   Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

TV44400-CNS-40083 (“CONFIDENCE”)

Study Overview

A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily.

Principle Investigator

Jessica Stulc, M.D,

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.

Alkermes ALK8700-A301 (“EVOLVE”)

Study Overview

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis.

Principle Investigator

Jessica Stulc, M.D,

Research Contact

If interested please contact Neha Goyal (Clinical Research Coordinator) @ 763-302-4072.