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

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT04468165
• Lead Sponsor: Hikma Pharmaceuticals LLC

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.

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2021-02-23
• Status Verified: 2023-03
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-20
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (6)

New University Hospital; 🇪🇬 Alexandria, Egypt

King Abdullah University Hospital (KAUH); 🇯🇴 Ar Ramtha, Jordan

Demerdash hospital (Ain Shams University); 🇪🇬 Cairo, Egypt

CHU Frantz FANON; 🇩🇿 Blida, Algeria

Nedir Mohamed Hospital; 🇩🇿 Tizi Ouzou, Algeria

Private Clinic; 🇪🇬 Cairo, Egypt