Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region

Study Overview
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Brief Summary
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The purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA Region

Detailed Description
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This is an observational, multi-center, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. In the study sites, patients undergoing routine clinical care for RRMS and initiated treatment with Generic DMF (Sclera® or Marovarex ®, Hikma) in accordance with the approved SPC will be followed up and assessed for a total of 12 months.

Official Title
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Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Dimethyl Fumarate (DMF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who initiate treatment with Hikma Generic DMF at baseline in accordance with the approved Summary of Product Characteristics Age ≥ 18 years Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are : Newly diagnosed who had no prior DMT, or Switched patients who had ≥1 prior DMTs, other than DMF Patients who agree to participate in the study and provide a written informed consent Exclusion Criteria: Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma), Fumaderm (fumaric acid esters), or compounded fumarates. Patients participating in other clinical studies Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dimethyl Fumarate (DMF)|Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month. | Relapses will be identified and recorded by Site investigators. A relapse is defined as any new or historical neurological symptom, not associated with fever or infection, lasting for at least 24 h and accompanied by new neurological signs. New or recurrent neurologic symptoms that occurred <30 days after the onset of a relapse as defined earlier were considered part of the same relapse. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities) |  | up to 12 months from Initiation of Hikma DMF | 
| Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed |  | up to 12 months from Initiation of Hikma DMF | 
| Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF |  | up to 12 months from Initiation of Hikma DMF | 
| Time to First Relapse |  | up to 12 months from Initiation of Hikma DMF | 
| Proportion of patients with disability progression as measured by the EDSS over time | Disability worsening is defined as 1.5-point increase (if baseline EDSS score was 0), 1.0-point increase (if baseline EDSS score was < 5.5) or 0.5- point increase (if baseline EDSS score was ≥ 5.5) confirmed at least 6 months apart | up to 12 months from Initiation of Hikma DMF | 
| Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time | The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. | up to 12 months from Initiation of Hikma DMF | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dimethyl Fumarate, Generic Dimethyl Fumarate, Delayed-Release Dimethyl Fumarate, Disease Modifying Treatments, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness, Safety, Health Related Quality of life