Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl Fumarate (DMF) | Drug | Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate |
|
| 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 |
| 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 |
Not provided
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 :
Patients who agree to participate in the study and provide a written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Frantz FANON | Blida | Algeria | ||||
| Nedir Mohamed Hospital |
Not provided
Not provided
Not provided
Not provided
| 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 |
| Tizi Ouzou |
| Algeria |
| New University Hospital | Alexandria | Egypt |
| Demerdash hospital (Ain Shams University) | Cairo | Egypt |
| Private Clinic | Cairo | Egypt |
| King Abdullah University Hospital (KAUH) | Ar Ramtha | Jordan |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009461 | Neurologic Manifestations |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided