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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

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
CompletedRelapsing MSNCT04468165

We could not find results for this trial

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What it found

No result found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

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

    12 Months

    Relapses

Other measures (6)

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

    up to 12 months from Initiation of Hikma DMF

    Safety

  • 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

    Safety

  • 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

    Relapses

  • Time to First Relapse

    up to 12 months from Initiation of Hikma DMF

    Relapses

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

    up to 12 months from Initiation of Hikma DMF

    Disability progression

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

    up to 12 months from Initiation of Hikma DMF

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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Related trials

History

    1. Started

      Feb 2021

    2. Main results due

      Jul 2023

    3. Finished

      Jul 2023

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