CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Tecfidera +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02739542
NCT02739542Phase 4Completed
CompareCT.gov

Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)

University of Texas Southwestern Medical Center·interventional·Posted Apr 15, 2016·Updated May 11, 2022

In Brief

A Phase 4 clinical trial evaluating Tecfidera and Placebo for Multiple Sclerosis (MS). Completed, enrolled 87 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis (MS)
CountriesUnited States
CollaboratorsBiogen

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 15, 2016
Enrollment StartMar 19, 2016
Primary CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.2 years ago

Interventions

Tecfideradrug

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.

Placebodrug

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.