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

HIK-DMF-2020-01

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

2021-02-23

2023-07-20

2023-07-20

Completed

160

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}

2023-09-22