Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

NCT01903291

Relapsing Forms of Multiple Sclerosis

COMPLETED

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

NCT01930708

Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis

COMPLETED PHASE4

Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States

NCT01873417

Relapsing Forms of Multiple Sclerosis

COMPLETED PHASE4

Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS

NCT02675413

Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting

WITHDRAWN PHASE4

Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

NCT04221191

Multiple Sclerosis, Relapsing-Remitting

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis, Relapsing-Remitting Relapsing-Remitting Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

administered according to the local product label (i.e., Canadian Product Monograph).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DMF BG00012 Tecfidera

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have access to the internet and are able to complete online assessments on a computer.
* Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph.
* Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment.

Exclusion Criteria

* Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
* Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
* Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No