Trial record 5 of 277 for:    (ARISE)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02739542
First received: March 16, 2016
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Multiple Sclerosis (MS)
Drug: Tecfidera
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, and 96. During clinical visits, comprehensive medical history data will be obtained by the treating physician. Clinical examinations as defined within this protocol will be performed at weeks 0, 48, and 96 and during or immediately following clinical exacerbations. 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, and 84 to assess for medical or treatment difficulties and for study medication compliance. Standardized MRI studies of the brain will be performed at weeks 0 and 96. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02739542

Contacts
Contact: Cindy Daniel, CCRP 214-645-9165 cindy.daniel@utsouthwestern.edu
Contact: Jose Santoyo, BS 214-645-0567 jose.santoyo@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8806
Contact: Cindy Daniel, CCRP    214-645-9165    cindy.daniel@utsouthwestern.edu   
Contact: Jose Santoyo, BS    214-645-0567    jose.santoyo@utsouthwestern.edu   
Principal Investigator: Darin T Okuda, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Biogen
Investigators
Principal Investigator: Darin T Okuda, MD UT Southwestern Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02739542     History of Changes
Other Study ID Numbers: 102014-019 
Study First Received: March 16, 2016
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Syndrome
Multiple Sclerosis
Disease
Pathologic Processes
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

ClinicalTrials.gov processed this record on July 28, 2016