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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468165
• Other study ID #: HIK-DMF-2020-01
• Status: Completed
• Start date: February 23, 2021
• Est. completion date: July 20, 2023

Study information

• Verified date: March 2023
• Source: Hikma Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Dimethyl Fumarate (DMF)
Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hikma Pharmaceuticals LLC

Countries where clinical trial is conducted

Algeria,  Egypt,  Jordan, 

Outcome

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