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

Hikma Pharmaceuticals LLC160 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Dimethyl Fumarate (DMF)DRUG

Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who initiate treatment with Hikma Generic DMF at baseline in accordance with the approved Summary of Product Characteristics 2. Age ≥ 18 years 3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are : 1. Newly diagnosed who had no prior DMT, or 2. Switched patients who had ≥1 prior DMTs, other than DMF 4. Patients who agree to participate in the study and provide a written informed consent Exclusion Criteria: 1. Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma), Fumaderm (fumaric acid esters), or compounded fumarates. 2. Patients participating in other clinical studies 3. Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics

Locations (6)

CHU Frantz FANON

Blida, Algeria

Nedir Mohamed Hospital

Tizi Ouzou, Algeria

New University Hospital

Alexandria, Egypt

Demerdash hospital (Ain Shams University)

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 12 Months

Secondary Outcomes

Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)