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Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) (ARISE)

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. Identifier: NCT02739542
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other than for the evaluation of MS (multiple sclerosis).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Drug: Tecfidera Drug: Placebo Phase 4

Detailed Description:

This is a multi-center, randomized, double-blinded study in which approximately 210 RIS (radiologically isolated syndrome) subjects will be treated with either Tecfidera or placebo for 2 years (1:1 randomization). Study participants, along with the treating and examining physicians, will be blinded to treatment assignment. Central Clinical and Imaging Units will screen all potential study subjects for inclusion/exclusion criteria. We expect to enroll all RIS subjects within the U.S.

Following informed consent and verification of entry criteria by the core units, study participants will be randomized 1:1 to either Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily) or placebo. Clinical follow-up by the treating physician will occur at weeks 0, 48, 96, 144 and/or End of Study and during or immediately following clinical exacerbations. During clinical visits, comprehensive medical history data will be obtained by the treating physician. All reported acute or progressive clinical events will be adjudicated by the Central Clinical Unit. Clinical visits due to suspected exacerbations associated with CNS (central nervous system) demyelination, and associated diagnostic studies and treatments, will be covered under the medical standard of care by third party payers. A recommendation to re-evaluate the patient within 3 months following the clinical event to assess for extent of recovery will be made. In addition to the face-to-face visits described above, study participants will be contacted over the telephone at weeks 4, 8, 36, 60, 84, 108, and 132 to assess for medical or treatment difficulties and for study medication compliance. Standardized MRI studies of the brain will be performed at weeks 0, 96, 144 or End of Study. Clinical imaging studies of the brain and/or spinal cord performed during or immediately following the onset of a clinical exacerbation will be performed at the discretion of the site PI with scan costs covered under the medical standard of care. An end of study clinical MRI of the cervical spinal cord with and without contrast will be recommended to study participants at week 96 as medical standard of care.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)
Actual Study Start Date : March 19, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Tecfidera
Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)
Drug: Tecfidera
Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.
Other Name: Dimethyl fumarate

Placebo Comparator: Placebo
Placebo by mouth twice daily.
Drug: Placebo
Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.

Primary Outcome Measures :
  1. The time from randomization to the first demyelinating event (acute or development of an initial symptom resulting in a progressive clinical course) [ Time Frame: Two years ]
    The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination from randomization into the trial.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Males and females meeting 2009 RIS criteria
  2. Identified RIS cases with the initial MRI demonstrating anomalies suggestive of demyelinating disease dated > 2009
  3. Incidental anomalies identified on MRI of the brain or spinal cord with the primary reason for the acquired MRI resulting from an evaluation of a process other than MS
  4. CNS white matter anomalies meeting the following MRI criteria:

    • Ovoid, well-circumscribed, and homogeneous foci with or without involvement of the corpus callosum
    • T2-hyperintensities measuring > 3mm2 and fulfilling 3 of 4 Barkhof-Tintoré criteria for dissemination in space
    • CNS anomalies not consistent with a vascular pattern
    • Qualitative determination that CNS anomalies have a characteristic appearance of demyelinating lesions
  5. MRI anomalies do not account for clinically apparent neurological impairments in patients

Exclusion criteria

  1. Women who are pregnant or nursing
  2. Incomplete medical history or radiological data
  3. History of remitting clinical symptoms consistent with multiple sclerosis lasting > 24 hours prior to CNS imaging revealing anomalies suggestive of MS
  4. History of paroxysmal symptoms associated with MS (i.e. Lhermitte's or Uhthoff's phenomena)
  5. CNS MRI anomalies are better accounted for by another disease process
  6. The subject is unwilling or unable to comply with the requirements of the study protocol
  7. Exposure to a disease modifying therapy for MS/RIS within the past 3 months
  8. Exposure to high-dose glucocorticosteroid treatment within the past 30 days
  9. Participation in other clinical trials involving treatment with a disease-modifying agent

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 identifier (NCT number): NCT02739542

Contact: Cindy Daniel, CCRP 214-645-9165
Contact: Jose Santoyo, BS 214-645-0567

United States, California
Keck School of Medicine - USC - Department of Neurology Recruiting
Los Angeles, California, United States, 90089
Contact: Rama Kishan Koppula    323-442-6021   
Principal Investigator: Lilyana Amezcua, MD         
United States, Colorado
University of Colorado - Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Brianna Blume    303-724-6386    BRIANNA.BLUME@UCDENVER.EDU   
Principal Investigator: Timothy Vollmer, MD         
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Angela Aungst    813-974-6378   
Principal Investigator: Derrick Robertson, MD         
United States, Maryland
Johns Hopkins University - Neurology Recruiting
Baltimore, Maryland, United States, 21287
Contact: Madiha Qutab    410-614-9201   
Principal Investigator: Ellen Mowry, MD         
United States, Minnesota
Mayo Clinic Department of Neurology Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sandra Looney    507-538-4107   
Principal Investigator: Orhun Kantarci, MD         
United States, Missouri
Washington University Department of Neurology Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Courtney Dula    314-362-3402   
Principal Investigator: Robert Naismith, MD         
United States, Nevada
Cleveland Clinic - Lou Ruvo Center for Brain Health Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Miranda Staples    702-701-7669   
Principal Investigator: Le Hua, MD         
United States, New York
MS Clinical Care and Research Center, Dept of Neurology, Columbia University Recruiting
New York, New York, United States, 10032
Contact: Eva Gelernt    212-342-4649   
Principal Investigator: Wendy Vargas, MD         
United States, Ohio
Ohio Health Neurology Recruiting
Columbus, Ohio, United States, 43214
Contact: Susan Foster    614-566-1268   
Principal Investigator: Aaron Boster, MD         
United States, Oklahoma
Oklahoma Medical Research Foundation, MS Center of Excellence Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Micki Moore    405-271-6241   
Principal Investigator: Gabriel Pardo, MD         
United States, Texas
MS Treatment Center of Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Victoria Stokes    214-818-2539   
Principal Investigator: Annette Okai, MD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8806
Contact: Cindy Daniel, CCRP    214-645-9165   
Contact: Jose Santoyo, BS    214-645-0567   
Principal Investigator: Darin T Okuda, MD         
Neurology Center of San Antonio Recruiting
San Antonio, Texas, United States, 78258
Contact: Tina Clements    210-490-0016 ext 23   
Principal Investigator: Ann Bass, MD         
United States, Vermont
University of Vermont Medical Center - MS Research Division - Department of Neurology Recruiting
Burlington, Vermont, United States, 05401
Contact: Jane Low    802-847-0983   
Principal Investigator: Andrew Solomon, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Caryl Tongco    206-215-3565   
Principal Investigator: Pavle Repovic, MD         
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Jarrod Monroe    253-403-7449   
Principal Investigator: Stacy Donlon, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Darin T Okuda, MD UT Southwestern Medical Center

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT02739542     History of Changes
Other Study ID Numbers: 102014-019
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Texas Southwestern Medical Center:
Radiologically Isolated Syndrome (RIS)

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs