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

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

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Dimethyl Fumarate (DMF)

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

• Study Contact: Name: Hikma Pharmaceuticals; Phone Number: 11663 009625805430; Email: rjaber@hikma.com

Study Locations

• Algeria
  • Blida, Algeria
    • CHU Frantz FANON
  • Tizi Ouzou, Algeria
    • Nedir Mohamed Hospital
• Egypt
  • Alexandria, Egypt
    • New University Hospital
  • Cairo, Egypt
    • Demerdash hospital (Ain Shams University)
  • Cairo, Egypt
    • Private Clinic
• Jordan
  • Ar Ramtha, Jordan
    • King Abdullah University Hospital (KAUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Hikma Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Safety; Relapsing-Remitting Multiple Sclerosis; Observational Study; Effectiveness; Cohort Study; Nervous System; Dimethyl Fumarate; Generic Dimethyl Fumarate; Delayed-Release Dimethyl Fumarate; Disease Modifying Treatments; Health Related Quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: HIK-DMF-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No