Clinical trial NCT04468165: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
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
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.
timeFrame: 12 Months
Secondary outcomes:
measure: Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)
timeFrame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed
timeFrame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF
timeFrame: up to 12 months from Initiation of Hikma DMF
measure: Time to First Relapse
timeFrame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients with disability progression as measured by the EDSS over time
timeFrame: up to 12 months from Initiation of Hikma DMF
measure: Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time
timeFrame: up to 12 months from Initiation of Hikma DMF
Other outcomes:
Locations:
city: Blida
country: Algeria
facility: CHU Frantz FANON
city: Tizi Ouzou
country: Algeria
facility: Nedir Mohamed Hospital
city: Alexandria
country: Egypt
facility: New University Hospital
city: Cairo
country: Egypt
facility: Demerdash hospital (Ain Shams University)
city: Cairo
country: Egypt
facility: Private Clinic
city: Ar Ramtha
country: Jordan
facility: King Abdullah University Hospital (KAUH)
Study officials:
References: