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Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Orhun Kantarci, M.D.

Closed for enrollment

More information

Publications

  • The aim of this study was to determine the prevalence of cerebrospinal fluid (CSF) and visual evoked potentials (VEP) abnormalities, and ANA titers in patients with either clinically or radiologically isolated syndrome (CIS and RIS). We gathered records from 330 hospitalized patients diagnosed with CIS/RIS within a 3-year period. Symptoms, CSF findings, VEP and ANA titers were analyzed. Incomplete transverse myelitis was the presenting symptom in 32.7 %, optic neuritis in 22.7 %, brainstem/cerebellar symptoms in 19.4 %, hemispheral symptoms in 2.7 % and multifocal symptoms in 15.2 % of patients in the CIS cohort. We identified 24 (7.3 %) patients with atypical or no symptoms-RIS cohort. Positive oligoclonal bands (OCB) were found in 75.5 % patients. When we divided the patients into CIS and RIS groups, the presence of OCB was 82.4 and 44 %, respectively. VEP were performed in 87.3 % patients and prolonged latencies were found in 39.6 % of them (43.8 and 14.3 % in the CIS and RIS cohort, respectively). ANA were positive in 15.2 % (14.7 and 16 % in the CIS and RIS cohort, respectively) of patients. RIS patients had statistically significant lower percentages of positive OCB and positive VEP (P = 0.002 and 0.001, respectively). Detection of OCB and VEP still has an important role for satisfying the "no better explanation for the clinical presentation" criteria when presented with a patient with a first "radiological" demyelinating episode. Read More on PubMed
  • In multiple sclerosis (MS), the relapse rate declines during pregnancy and increases during the first three months post-partum before returning to the pre-pregnancy rate. It is unknown whether pregnancy impacts the risk of clinical conversion in those within the presymptomatic period. Read More on PubMed
  • To assess the presence of cortical lesions (CLs) as detected by MRI in subjects with radiologically isolated syndrome (RIS). Read More on PubMed
  • To improve the characterization of asymptomatic subjects with brain magnetic resonance imaging (MRI) abnormalities highly suggestive of multiple sclerosis (MS), a condition named as "radiologically isolated syndrome" (RIS). Read More on PubMed
  • New evidence and consensus has led to further revision of the McDonald Criteria for diagnosis of multiple sclerosis. The use of imaging for demonstration of dissemination of central nervous system lesions in space and time has been simplified, and in some circumstances dissemination in space and time can be established by a single scan. These revisions simplify the Criteria, preserve their diagnostic sensitivity and specificity, address their applicability across populations, and may allow earlier diagnosis and more uniform and widespread use. Read More on PubMed
  • Technological advancements in neuroimaging and the increased use of these diagnostic modalities are responsible for the discovery of incidentally identified anomalies within the CNS. In addition to the identification of unanticipated brain MRI abnormalities suggestive of demyelinating disease in patients undergoing neuroimaging for a medical reason other than evaluation for multiple sclerosis (MS), asymptomatic spinal cord lesions are periodically identified. Read More on PubMed
  • Radiologically isolated syndrome (RIS) is characterized by patients with asymptomatic T2 hypersignals detected by brain MRI fulfilling dissemination in space criteria and is suggestive of subclinical multiple sclerosis (MS). In previous studies, it was demonstrated that visual evoked potential and cerebrospinal fluid help to identify pejorative markers in converting to MS. Read More on PubMed
  • Natural history of patients with incidentally discovered lesions that fulfill magnetic resonance imaging (MRI) criteria for multiple sclerosis (MS) in the absence of objective clinical symptoms suggestive of central nervous system (CNS) inflammatory-demyelinating disease is not well defined. Read More on PubMed
  • The concept of preclinical multiple sclerosis is now well recognised, and a diagnosis of silent brain T2 lesions is frequent because of the ease of performing MRI. Nevertheless, patients with incidental brain MRI fulfilling Barkhof- Tintoré criteria are more rare. We report a descriptive retrospective study of clinical and 5 year MRI follow-up in patients with subclinical demyelinating lesions fulfilling MRI Barkhof-Tintoré criteria with a normal neurological examination. 30 patients were identified and the first brain MRI was performed for various medical events: headaches (n = 14), migraine with (n = 2) or without (n = 4) aura, craniocerebral trauma (n = 3), depression (n = 3), dysmenorrhoea (n = 2), epilepsy (n = 1) and cognitive changes (n = 1). Mean time for the second brain MRI was 6 months (range 3-30). 23 patients had temporospatial dissemination (eight with gadolinium enhancement). 11 patients had clinical conversion: optic neuritis (n = 5), brainstem (n = 3), sensitive symptoms (n = 2) and cognitive deterioration (n = 1). Eight (72%) already had criteria of dissemination to space and time before the clinical event. Mean time between the first brain MRI and clinically isolated syndrome (CIS) was 2.3 years. To our knowledge, this is the first cohort of CIS with preclinical follow-up. Early treatment should be discussed in view of the predictive value on conversion of the MRI burden of the disease. Read More on PubMed
  • New diagnostic criteria for multiple sclerosis integrating magnetic resonance image assessment with clinical and other paraclinical methods were introduced in 2001. The "McDonald Criteria" have been extensively assessed and used since 2001. New evidence and consensus now strengthen the role of these criteria in the multiple sclerosis diagnostic workup to demonstrate dissemination of lesions in time, to clarify the use of spinal cord lesions, and to simplify diagnosis of primary progressive disease. The 2005 Revisions to the McDonald Diagnostic Criteria for MS should simplify and speed diagnosis, whereas maintaining adequate sensitivity and specificity. Read More on PubMed

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