Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
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
Verified date | March 2023 |
Source | Hikma Pharmaceuticals LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 160 |
Est. completion date | July 20, 2023 |
Est. primary completion date | July 20, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Algeria | CHU Frantz FANON | Blida | |
Algeria | Nedir Mohamed Hospital | Tizi Ouzou | |
Egypt | New University Hospital | Alexandria | |
Egypt | Demerdash hospital (Ain Shams University) | Cairo | |
Egypt | Private Clinic | Cairo | |
Jordan | King Abdullah University Hospital (KAUH) | Ar Ramtha |
Lead Sponsor | Collaborator |
---|---|
Hikma Pharmaceuticals LLC |
Algeria, Egypt, Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities) | up to 12 months from Initiation of Hikma DMF | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Time to First Relapse | up to 12 months from Initiation of Hikma DMF | ||
Secondary | 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 | |
Secondary | 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 |
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