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Completed

NCT Number: 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

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

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Frantz FANON, Blida, Algeria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who initiate treatment with Hikma Generic DMF at baseline in accordance with the approved Summary of Product Characteristics
  • Age ≥ 18 years
  • Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are :
  • Newly diagnosed who had no prior DMT, or
  • Switched patients who had ≥1 prior DMTs, other than DMF
  • Patients who agree to participate in the study and provide a written informed consent

Exclusion criteria

  • Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma), Fumaderm (fumaric acid esters), or compounded fumarates.
  • Patients participating in other clinical studies
  • Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics

Treatment and study plan

Dimethyl Fumarate (DMF)

Drug

Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate

Other names: Sclera ®, Hikma, Marovarex ®, Hikma

Primary outcomes

  1. The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.

    Time frame: 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 outcomes

  1. Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)

    Time frame: up to 12 months from Initiation of Hikma DMF

  2. Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed

    Time frame: up to 12 months from Initiation of Hikma DMF

  3. Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF

    Time frame: up to 12 months from Initiation of Hikma DMF

  4. Time to First Relapse

    Time frame: up to 12 months from Initiation of Hikma DMF

  5. Proportion of patients with disability progression as measured by the EDSS over time

    Time frame: 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

  6. Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2020
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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