Clinical Trials Logo

Clinical Trial Summary

This study will observe participants with relapsing remitting multiple sclerosis who are switching therapies from natalizumab to dimethyl fumarate to determine disease stability.


Clinical Trial Description

This is an investigator initiated, single site, open-label, single arm observational study examining the initial efficacy and tolerability of dimethyl fumarate in a real world clinical setting for patients with a relapsing form of Multiple Sclerosis (MS) when crossed over from natalizumab therapy.

The decision to cross over from natalizumab to DMF will be made by the patient and the prescribing physician and must precede enrollment in the study.

MS disease status and history will be gathered from the patient's medical records. Patients will be followed for the first 24 weeks of their transition from natalizumab. Assessments will be performed at Baseline and every 4 weeks thereafter for 24 weeks. These assessments may include:

- Expanded Disability Status Scale (EDSS)

- Relapse Assessment

- Patient Reported Outcomes (PRO) including quality of life, fatigue, and cognition outcome measures

- Magnetic Resonance Imaging (MRI)

- Laboratory testing

Study drop outs due to DMF intolerability or other etiologies will be encouraged to complete the trial even if placed on alternative therapies. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing Remitting Multiple Sclerosis

NCT number NCT01945359
Study type Observational
Source Rocky Mountain MS Research Group, LLC
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date June 2015

See also
  Status Clinical Trial Phase
Completed NCT01450124 - Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) Phase 2
Completed NCT01456416 - Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities Phase 4
Recruiting NCT05277740 - Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Completed NCT03718247 - Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
Active, not recruiting NCT03471338 - Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme N/A
Recruiting NCT03004079 - Clinical Importance of Glucose Regulation in Relapsing MS
Terminated NCT02266121 - Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis N/A
Completed NCT01963611 - Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) Phase 2
Active, not recruiting NCT01464905 - Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Phase 3
Completed NCT01225289 - Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients Phase 4
Recruiting NCT00242268 - A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis Phase 3
Completed NCT00203086 - A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis Phase 4
Completed NCT00616187 - Atorvastatin in Relapsing-Remitting Multiple Sclerosis Phase 2
Recruiting NCT06083753 - Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis Phase 2
Active, not recruiting NCT04602390 - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis Phase 1
Recruiting NCT06159712 - Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis N/A
Recruiting NCT04604041 - Investigation of Subclinical Markers of Multiple Sclerosis
Terminated NCT03536559 - Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis Phase 2
Completed NCT02490982 - Teriflunomide Observational Effectiveness Study
Withdrawn NCT00939549 - High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis Phase 2