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Real-World study tests cladribine tablets for MS patients who failed other drugs

NCT ID NCT03933202

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at how well cladribine tablets work in everyday practice for people with relapsing multiple sclerosis (MS) who had a poor response to other oral or infusion treatments. Researchers tracked 291 participants over 24 months, measuring relapse rates and patient satisfaction. The goal was to see if switching to cladribine improves outcomes in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cladribine tablets
What this could lead to
If successful, this could confirm that cladribine tablets are a good option for people with MS who haven't done well on other medications.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It also only included people who already switched to cladribine, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

291 people

The number who actually took part.

Started

Jul 2019

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528, United States

  • Ascension St. Francis Center for Neurological Disorders, S.C.

    Milwaukee, Wisconsin, 53215, United States

  • Associated Neurologists of Southern Connecticut, PC

    Fairfield, Connecticut, 06824, United States

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baylor College of Medicine IRB

    Houston, Texas, 77030, United States

  • Blacksburg Neurology, PC

    Christiansburg, Virginia, 24073, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • College Park Family Care Center

    Overland Park, Kansas, 66212, United States

  • Colorado Springs Neurological Associates, PC - Neurology

    Colorado Springs, Colorado, 80907, United States

  • DENT Neurologic Institute

    Amherst, New York, 14226, United States

  • DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis

    McAllen, Texas, 78503, United States

  • Dayton Center for Neurological Disorders

    Dayton, Ohio, 45459, United States

  • Detroit Clinical Research Center, PC

    Farmington Hills, Michigan, 48334, United States

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835, United States

  • Guilford Neurologic Associates

    Greensboro, North Carolina, 27405, United States

  • HCA Research Institute

    Englewood, Colorado, 80113, United States

  • Insight Neuroscience LLC

    Bellevue, Ohio, 44811, United States

  • Integrated Neurology Services - Dr. Simon Fishman's Office

    Alexandria, Virginia, 22310, United States

  • MS Center of Evergreen

    Kirkland, Washington, 98034, United States

  • Massey Cancer Center - VCU Medical Center

    Richmond, Virginia, 23298, United States

  • Memorial Healthcare

    Owosso, Michigan, 48867, United States

  • Meridian Clinical Research (Neurology)

    Norfolk, Virginia, 23502, United States

  • Minneapolis Clinic of Neurology - Neurology

    Golden Valley, Minnesota, 55422, United States

  • MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research

    Tacoma, Washington, 98405, United States

  • MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and

    Spokane, Washington, 99202, United States

  • Multiple Sclerosis Center of Greater Washington

    Vienna, Virginia, 22182, United States

  • NYU Langone Brooklyn - Brooklyn

    Brooklyn, New York, 11220, United States

  • Neuro Institute of New England P.C.

    Foxborough, Massachusetts, 02035, United States

  • Neurological Associates

    Richmond, Virginia, 23226, United States

  • Neurological Clinical Research Institute

    Boston, Massachusetts, 02114, United States

  • Neurology Associates, P. A.

    Maitland, Florida, 32751, United States

  • Neurology Center of Las Vegas

    Las Vegas, Nevada, 89128, United States

  • Neurology Center of San Antonio

    San Antonio, Texas, 78258, United States

  • Neurology, PC

    Knoxville, Tennessee, 37922, United States

  • Neuroscience Group of Northeast Wisconsin - DUPLICATE

    Neenah, Wisconsin, 54956, United States

  • North Central Neurology Associates, P.C.

    Cullman, Alabama, 35058, United States

  • Northern Light Comprehensive Multiple Sclerosis Care Center

    Bangor, Maine, 04401, United States

  • Northwest Houston Neurology

    Cypress, Texas, 77429, United States

  • Northwest Neurology Ltd

    Rolling Meadows, Illinois, 60008, United States

  • Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando

    Orlando, Florida, 32806, United States

  • Prairie Education & Research

    Springfield, Illinois, 62702, United States

  • Premier Neurology Research, P.C.

    Greer, South Carolina, 29650, United States

  • Providence Neurological Specialties

    Portland, Oregon, 97225, United States

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6010, United States

  • Regina Berkovich MD PhD INC

    West Hollywood, California, 90048, United States

  • Riverhills Neuroscience

    Cincinnati, Ohio, 45212, United States

  • Sentara Ambulatory Care Center

    Virginia Beach, Virginia, 23456, United States

  • Suncoast Neuroscience and Associates, Inc.

    St. Petersburg, Florida, 33713, United States

  • The Boster Center for Multiple Scelosis

    Columbus, Ohio, 43235, United States

  • The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System

    Charlotte, North Carolina, 28203, United States

  • The Elliot Lewis Center for Multiple Sclerosis Care

    Wellesley, Massachusetts, 02481, United States

  • The Medical College of Wisconsin - Endocrinology

    Milwaukee, Wisconsin, 53226, United States

  • The Trustee of Columbia University in the City of New York

    New York, New York, 10032, United States

  • UMASS - Neurology

    Worcester, Massachusetts, 01655, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of South Alabama

    Mobile, Alabama, 36693, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Toledo - PARENT

    Toledo, Ohio, 43614-2598, United States

  • VCU Medical Center - Pediatric Neurology

    Richmond, Virginia, 23298-0211, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology

    Detroit, Michigan, 48201, United States

  • Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Yale University

    Fairfield, Connecticut, 06824, United States

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