Purpose

To evaluate the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion DMD approved in the United States (US) for RMS in a real-world-setting.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Signed informed consent - Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI) - Have time since diagnosis of RMS of at least 12 months - In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets - Had received their last previous oral DMD for at least 3 months - Have decided to initiate treatment with cladribine tablets during routine clinical care - Meet criteria as per the approved USPI - Have access to a valid e-mail address

Exclusion Criteria

  • Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral) - Transitioning from previous oral DMD solely for administrative reasons such as relocation - Have comorbid conditions that preclude participation - Have any clinical condition or medical history noted as contraindication on USPI - Are currently participating in an interventional clinical trial - Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cladribine Tablets No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants.
  • Drug: Cladribine Tablets
    No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.

Recruiting Locations

North Central Neurology Associates, P.C.
Cullman, Alabama 35058

University of South Alabama
Mobile, Alabama 36693

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

Fullerton Neurology and Headache Center
Fullerton, California 92835

Regina Berkovich MD PhD INC
West Hollywood, California 90048

Colorado Springs Neurological Associates, PC - Neurology
Colorado Springs, Colorado 80907

HCA Research Institute
Englewood, Colorado 80113

Advanced Neurosciences Research, LLC
Fort Collins, Colorado 80528

Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut 06824

Neurology Associates, P. A.
Maitland, Florida 32751

University of Miami
Miami, Florida 33136

Suncoast Neuroscience and Associates, Inc.
Saint Petersburg, Florida 33713
Contact:
abvmd@aol.com

Axiom Clinical Research of Florida
Tampa, Florida 33609

University of South Florida
Tampa, Florida 33612

Northwest Neurology Ltd
Rolling Meadows, Illinois 60008

Prairie Education & Research
Springfield, Illinois 62702

Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
Contact:
agupta@fwnc.com

College Park Family Care Center
Overland Park, Kansas 66212

Baptist Health Lexington
Lexington, Kentucky 40503

Northern Light Comprehensive Multiple Sclerosis Care Center
Bangor, Maine 04401

Neuro Institute of New England P.C.
Foxboro, Massachusetts 02035

The Elliot Lewis Center for Multiple Sclerosis Care
Wellesley, Massachusetts 02481

UMASS - Neurology
Worcester, Massachusetts 01655

Detroit Clinical Research Center, PC
Farmington Hills, Michigan 48334

Memorial Healthcare
Owosso, Michigan 48867

Neurology Center of Las Vegas
Las Vegas, Nevada 89128

NYU Langone Brooklyn - Brooklyn
Brooklyn, New York 11220

The Trustee of Columbia University in the City of New York
New York, New York 10032

Guilford Neurologic Associates
Greensboro, North Carolina 27405

Raleigh Neurology Associates
Raleigh, North Carolina 27607-6010

Insight Neuroscience LLC
Bellevue, Ohio 44811

Riverhills Neuroscience
Cincinnati, Ohio 45212

Dayton Center for Neurological Disorders
Dayton, Ohio 45459

University of Toledo - PARENT
Toledo, Ohio 43614-2598

Providence Neurological Specialties
Portland, Oregon 97225

Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
Philadelphia, Pennsylvania 19107

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Baylor College of Medicine IRB
Houston, Texas 77030
Contact:
ghutton@bcm.edu

Central Texas Neurology Consultants
Round Rock, Texas 78681

Neurology Center of San Antonio
San Antonio, Texas 78258

Integrated Neurology Services - Dr. Simon Fishman's Office
Alexandria, Virginia 22310

Blacksburg Neurology, PC
Christiansburg, Virginia 24073

Meridian Clinical Research (Neurology)
Norfolk, Virginia 23502

Neurological Associates
Richmond, Virginia 23226

VCU Medical Center - Pediatric Neurology
Richmond, Virginia 23298-0211
Contact:
wlfelton@vcu.edu

Multiple Sclerosis Center of Greater Washington
Vienna, Virginia 22182

Sentara Ambulatory Care Center
Virginia Beach, Virginia 23456

MS Center of Evergreen
Kirkland, Washington 98034

MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
Spokane, Washington 99202

Ascension St. Francis Center for Neurological Disorders, S.C.
Milwaukee, Wisconsin 53215

More Details

NCT ID
NCT03933202
Status
Recruiting
Sponsor
EMD Serono Research & Development Institute, Inc.

Study Contact

US Medical Information
888-275-7376
eMediUSA@emdserono.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.