Status:
COMPLETED
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
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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 clinic...
Detailed Description
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 routin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04468165
Start Date
February 23 2021
End Date
July 20 2023
Last Update
September 22 2023
Active Locations (6)
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1
CHU Frantz FANON
Blida, Algeria
2
Nedir Mohamed Hospital
Tizi Ouzou, Algeria
3
New University Hospital
Alexandria, Egypt
4
Demerdash hospital (Ain Shams University)
Cairo, Egypt