Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
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
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 clinical care for RRMS in MENA Region
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 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.
Interventions
Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
Sponsors
Hikma Pharmaceuticals LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month. | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 disability progression as measured by the EDSS over time | up to 12 months from Initiation of Hikma DMF | 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 |
| Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time | up to 12 months from Initiation of Hikma DMF | 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. |
| Time to First Relapse | up to 12 months from Initiation of Hikma DMF | — |
Countries
Algeria, Egypt, Jordan
Outcome results
None listed