A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)
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
- Multiple Sclerosis
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 1 month or at least 1 dose of their last previous infusion DMD - 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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Fullerton Neurology and Headache Center
Fullerton, California 92835
Fullerton, California 92835
Colorado Springs Neurological Associates, PC - Neurology
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut 06824
Fairfield, Connecticut 06824
College Park Family Care Center
Overland Park, Kansas 66212
Overland Park, Kansas 66212
Northern Light Comprehensive Multiple Sclerosis Care Center
Bangor, Maine 04401
Bangor, Maine 04401
The Elliot Lewis Center for Multiple Sclerosis Care
Wellesley, Massachusetts 02481
Wellesley, Massachusetts 02481
Detroit Clinical Research Center, PC
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
The Trustee of Columbia University in the City of New York
New York, New York 10032
New York, New York 10032
The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Guilford Neurologic Associates
Greensboro, North Carolina 27405
Greensboro, North Carolina 27405
Raleigh Neurology Associates
Raleigh, North Carolina 27607-6010
Raleigh, North Carolina 27607-6010
Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Integrated Neurology Services - Dr. Simon Fishman's Office
Alexandria, Virginia 22310
Alexandria, Virginia 22310
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
Spokane, Washington 99202
Spokane, Washington 99202
Ascension St. Francis Center for Neurological Disorders, S.C.
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
More Details
- NCT ID
- NCT03933202
- Status
- Recruiting
- Sponsor
- EMD Serono Research & Development Institute, Inc.