Real-world Outcomes on Tecfidera® (BG00012, Dimethyl Fumarate) Post-Tysabri® (BG00002, Natalizumab)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | July 2014 |
| End Date: | December 2014 |
| Contact: | Biogen Idec |
| Email: | clinicaltrials@biogenidec.com |
A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)
The primary objective of the study is to evaluate relapse activity, as measured by the
proportion of participants relapsed at 12 months, in participants with relapsing-remitting
multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in
the real-world setting. The secondary objective is to further evaluate relapse activity,
defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid
use, during the first year of Tecfidera treatment following transition from Tysabri
treatment.
proportion of participants relapsed at 12 months, in participants with relapsing-remitting
multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in
the real-world setting. The secondary objective is to further evaluate relapse activity,
defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid
use, during the first year of Tecfidera treatment following transition from Tysabri
treatment.
The study period will consist of a single time point retrospective medical chart abstraction
with no required study visits or procedures. Data collection for this study is expected to
last up to approximately five months.
with no required study visits or procedures. Data collection for this study is expected to
last up to approximately five months.
Key Inclusion Criteria:
- Diagnosis of RRMS per McDonald criteria
- Received at least 12 months of continuous treatment with Tysabri monotherapy prior to
initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as
treatment uninterrupted by other disease-modifying treatment.
- Initiated treatment with Tecfidera at least 12 months prior to enrollment into the
study
- Patient has sufficient available medical records for data abstraction to meet the
objectives of the study
Key Exclusion Criteria:
- Diagnosed with a progressive form of MS (progressive-relapsing, primary progressive,
secondary progressive)
- Received treatment with any of the following after discontinuation of Tysabri and
before initiation of treatment with Tecfidera (i.e., during washout period):
interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab,
alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
- Received BG-12, or other formulations of dimethyl fumarate, or Fumaderm® or
compounded fumarates at any time prior to initiation of treatment with Tecfidera
- History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or
within 6 months of discontinuing treatment with Tysabri
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
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