Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT02739542
• Date of registration: 16/03/2016
• Prospective Registration: Yes
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) ARISE
• Scientific title: Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)
• Date of first enrolment: March 19, 2016
• Target sample size: 87
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02739542
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Darin T Okuda, MD
• Affiliation: UT Southwestern Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis (MS)

Intervention(s)

Drug: Tecfidera

Drug: Placebo

Primary Outcome(s)

The time from randomization to the first demyelinating event (acute or development of an initial symptom resulting in a progressive clinical course) [Time Frame: three years]

Secondary ID(s)

102014-019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen