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A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933215
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : January 17, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
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 injectable DMD approved in the United States (US) for RMS in a real-world setting.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Cladribine Tablets

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Injectable Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS)
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : November 29, 2023
Estimated Study Completion Date : November 29, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

Group/Cohort Intervention/treatment
Cladribine Tablets
No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any injectable 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.




Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) (Prospective Assessment) [ Time Frame: Baseline (Month 0) up to 24 Months ]
    For this study, a relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.


Secondary Outcome Measures :
  1. Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  2. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  3. Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  4. Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  5. Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  6. Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  7. Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) [ Time Frame: Baseline (Month 0) and at the end of Months 1, 2, 13 and 14 ]
  8. Percentage of Participants with Relapse (Prospective Assessment) [ Time Frame: Month 12 and 24 ]
    For this study, a relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.

  9. Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization [ Time Frame: Month 12 and 24 ]
    For this study, a relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse associated with hospitalization, diagnosis or reason for hospitalization will be reported.

  10. Percentage of Participants With Relapse Associated With Glucocorticoid Use [ Time Frame: Month 12 and 24 ]
    For this study, a relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse associated with glucocorticoid use up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.

  11. Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS) [ Time Frame: At Baseline (Month 0) ]
  12. Percentage of Participants Who Discontinue Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  13. Percentage of Participants With Reason for Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  14. Elapsed Time to Discontinuation After First Dose of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  15. Number of Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  16. Percentage of Planned Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  17. Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  18. Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period [ Time Frame: Baseline (Month 0) up to 24 Months ]
  19. Annualized Relapse Rate (ARR) (Retrospective Assessment) [ Time Frame: Up to 24 Months prior Baseline (Month 0) ]
    For this study, a relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR up to 24 months prior to baseline (retrospectively collected data) will be reported.

  20. Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations [ Time Frame: Baseline (Month 0) up to 24 months ]
    A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with Multiple Sclerosis and experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to prior treatment with an injectable DMD.
Criteria

Inclusion Criteria:

  • Male or female participants greater than or equal to (>=)18 years
  • 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
  • Had received their last previous injectable disease-modifying drug (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
  • In the opinion of the Investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment

Exclusion Criteria:

  • Have been previously treated with cladribine in any dosing form
  • Transitioning from previous injectable 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 the cladribine treatment period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933215


Contacts
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Contact: US Medical Information 888-275-7376 service@emdgroup.com

Locations
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United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36693
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact       lmbarganier2@uams.edu   
Principal Investigator: Laura Barganier         
United States, California
Regina Berkovich MD PhD INC Recruiting
West Hollywood, California, United States, 90048
Contact       reginaberkovichmd@gmail.com   
Principal Investigator: Regina Berkovich         
United States, Colorado
Mountain Neurological Research Center Recruiting
Basalt, Colorado, United States, 81621
Contact       allen@roaringforkneurology.com   
Principal Investigator: Alison Brooke Allen         
Colorado Springs Neurological Associates, PC - Neurology Recruiting
Colorado Springs, Colorado, United States, 80907
Contact       aeadala@gmail.com   
Principal Investigator: Aparna Komatineni         
HCA Research Institute Recruiting
Englewood, Colorado, United States, 80113
Contact       abneurocare@qwestoffice.net   
Principal Investigator: Allen C Bowling         
Advanced Neurosciences Research Recruiting
Fort Collins, Colorado, United States, 80528
Contact       amiravalle@yahoo.com   
Principal Investigator: Augusto A Miravalle         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact       neetagarg@miami.edu   
Principal Investigator: Neeta Garg         
Suncoast Neuroscience and Associates, Inc. Recruiting
Saint Petersburg, Florida, United States, 33713
Contact       abvmd@aol.com   
Principal Investigator: Alberto B Vasquez         
The Roskamp Institute - Clinical Trials Division Recruiting
Sarasota, Florida, United States, 34243
Contact       akeegan@roskampinstitute.org   
Principal Investigator: Andrew P Keegan         
Axiom Clinical Research of Florida Recruiting
Tampa, Florida, United States, 33609
Contact       mcascione.axiom@gmail.com   
Principal Investigator: Mark C Cascione Cascione         
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact       droberts@health.usf.edu   
Principal Investigator: Derrick S Robertson         
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46804
Contact       agupta@fwnc.com   
Principal Investigator: Ajay S Gupta         
United States, Kansas
College Park Family Care Center Recruiting
Overland Park, Kansas, United States, 66212
Contact       jeffrey.kaplan@hcahealthcare.com   
Principal Investigator: Jeffrey M Kaplan         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact       james.winkley@bhsi.com   
Principal Investigator: James M Winkley Winkley         
University of Kentucky - Department of Neurology Recruiting
Lexington, Kentucky, United States, 40536
Contact       javasarala@uky.edu   
Principal Investigator: Jagannadha Avasarala         
United States, Massachusetts
Neuro Institute of New England P.C. Recruiting
Foxboro, Massachusetts, United States, 02035
Contact       snapoli@myneurodr.com   
Principal Investigator: Salvatore Napoli         
Beth Israel Deaconess Medical Center, Inc. Recruiting
Jamaica Plain, Massachusetts, United States, 02130-2075
Contact       jsloane@bidmc.harvard.edu   
Principal Investigator: Jacob A Sloane         
The Elliot Lewis Center for Multiple Sclerosis Care, LLC Recruiting
Wellesley, Massachusetts, United States, 02481
Principal Investigator: Joshua Katz, Dr.         
UMASS - Neurology Recruiting
Worcester, Massachusetts, United States, 01655
Contact       andrew.bouley@umassmemorial.org   
Principal Investigator: Andrew Bouley         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact       mcerghe1@hfhs.org   
Principal Investigator: Mirela Cerghet         
Memorial Healthcare Recruiting
Owosso, Michigan, United States, 48867
Contact       rob@paceneuro.com   
Principal Investigator: Robert J Pace         
Dr. Steven Schechter's Office Recruiting
West Bloomfield, Michigan, United States, 48322
Contact       steven.schechter@dcrc.us   
Principal Investigator: Steven H Schechter         
United States, Missouri
Mercy Research - Mercy Hospital St. Louis Research Institute Recruiting
Saint Louis, Missouri, United States, 63141
Contact       amy.rauchway@mercy.net   
Principal Investigator: Amy C Rauchway         
United States, Nevada
Neurology Center of Las Vegas Recruiting
Las Vegas, Nevada, United States, 89128
Contact       sdixit@interspond.com   
Principal Investigator: Shanker N Dixit         
United States, New York
Neurological Associates of Long Island, P.C. Recruiting
New Hyde Park, New York, United States, 11042
Contact       tracydeangelis73@gmail.com   
Principal Investigator: Teresa DeAngelis         
The Trustee of Columbia University in the City of New York Recruiting
New York, New York, United States, 10032
Contact       rs3648@cumc.columbia.edu   
Principal Investigator: Rebecca Farber         
United States, North Carolina
Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27405
Contact       richard.sater@conehealth.com   
Principal Investigator: Richard Sater         
United States, Ohio
Insight Neuroscience LLC Recruiting
Bellevue, Ohio, United States, 44811
Contact       bbauer@advneuroassoc.com   
Principal Investigator: Brendan W Bauer         
Riverhills Neuroscience Recruiting
Cincinnati, Ohio, United States, 45212
Contact       mbowman@riverhillsneuro.com   
Principal Investigator: Michelle Bowman         
Dayton Center for Neurological Disorders Recruiting
Dayton, Ohio, United States, 45459
Contact       kmankowski@dcndinc.com   
Principal Investigator: Kenneth A Mankowski         
University of Toledo - PARENT Recruiting
Toledo, Ohio, United States, 43614-2598
Contact       talal.derani@utoledo.edu   
Principal Investigator: Talal Derani         
MDH Research, LLC Recruiting
Westerville, Ohio, United States, 43081
Contact       dhuang@mdhresearch.com   
Principal Investigator: Deren Huang         
United States, Oregon
Providence Neurological Specialties Recruiting
Portland, Oregon, United States, 97225
Contact       kyle.smoot@providence.org   
Principal Investigator: Kyle E Smoot         
United States, Texas
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
Contact       ctnc.research@gmail.com   
Principal Investigator: Edward J Fox         
Neurology Center of San Antonio Recruiting
San Antonio, Texas, United States, 78258
Contact       annofb@hotmail.com   
Principal Investigator: Ann D Bass         
United States, Vermont
Fletcher Allen Health Care, Inc. - Hematology/Oncology Unit Recruiting
Burlington, Vermont, United States, 05401
Contact       chantal.roy-hewitson@vtmednet.org   
Principal Investigator: Chantal Roy-Hewitson         
United States, Virginia
Integrated Neurology Services - Dr. Simon Fishman's Office Recruiting
Alexandria, Virginia, United States, 22310
Contact       sfishman@integratedneurologyservices.com   
Principal Investigator: Simon Fishman         
Blacksburg Neurology, PC Recruiting
Christiansburg, Virginia, United States, 24073
Contact       cramerj01@gmail.com   
Principal Investigator: Jill Cramer         
Neurological Associates Recruiting
Richmond, Virginia, United States, 23229
Contact       alan.schulman@hcahealthcare.com   
Principal Investigator: Alan E Schulman         
VCU Medical Center - Pediatric Neurology Recruiting
Richmond, Virginia, United States, 23298-0211
Contact       wlfelton@vcu.edu   
Principal Investigator: Warren L Felton         
Sentara Ambulatory Care Center Recruiting
Virginia Beach, Virginia, United States, 23456
Contact       mbkuczma@sentara.com   
Principal Investigator: Michelle B Kuczma         
United States, Washington
MS Center of Evergreen Recruiting
Kirkland, Washington, United States, 98034
Contact       trbrown@evergreenhealth.com   
Principal Investigator: Theodore R Brown         
United States, Wisconsin
Neuroscience Group of Northeast Wisconsin Recruiting
Neenah, Wisconsin, United States, 54956
Principal Investigator: Susan Hibba, Dr.         
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03933215    
Other Study ID Numbers: MS700568_0078
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: January 17, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Multiple Sclerosis
Cladribine Tablets
Observational
Mavenclad
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs