Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy Save

Date Added
December 10th, 2015
PRO Number
Pro00048449
Researcher
Jagannadha Avasarala
Keywords
Multiple Sclerosis
Summary

The main purpose of this study in people with MS, either newly prescribed GILENYA or receiving another approved medication, is to evaluate long-term safety of Gilenya and to further explore the incidence of selected safety outcomes.
Patients eligible for participation in this study will, as part of their routine medical care, receive either fingolimod (fingolimod-cohort) or another approved disease-modifying therapy (parallel cohort). All patients will have 3 or 4 mandatory visits (Baseline, Month 3, change in MS therapy (if applicable) and end of study); beyond those, visits will be according to routine practice. Protocol recommended visits are aligned with patterns of care that most patients will receive in routine clinical practice.
The prescription of fingolimod or any other DMT is at the sole discretion of the prescribing physicians, is not part of the study plan and will not be provided by the study sponsor

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM) Save

Date Added
September 10th, 2015
PRO Number
Pro00044761
Researcher
Jagannadha Avasarala
Keywords
Multiple Sclerosis
Summary

The purpose of this study is to better characterize the long-term benefit-risk profile of DMF in patients with multiple sclerosis (MS) who are prescribed DMF under routine clinical care.
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events, including but not limited to serious infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events leading to treatment discontinuation, in patients with MS treated with DMF. Secondary study objectives are to (1) determine DMF prescription and utilization patterns in routine clinical practice in patients with MS; (2) assess the effectiveness of DMF on MS disease activity and disability progression; and (3) assess the effect of DMF on health-related quality of life, healthcare resource consumption, and work productivity.

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

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