Relapsing Remitting Multiple SclerosisNCT04468165
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
An observational study of Relapsing Remitting Multiple Sclerosis, run by Hikma Pharmaceuticals LLC at 6 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Dimethyl Fumarate (DMF)
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 23 Feb 2021to 20 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Egypt3 sites
New University Hospital
Alexandria
Demerdash hospital (Ain Shams University)
Cairo
Private Clinic
Cairo
About this study
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
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Dimethyl Fumarate (DMF)
- Keywords
- Dimethyl Fumarate, Generic Dimethyl Fumarate, Delayed-Release Dimethyl Fumarate, Disease Modifying Treatments, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness, Safety, Health Related Quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Neurologic Manifestations, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl Fumarate (DMF)Drug
Also called Sclera ®, Hikma, Marovarex ®, Hikma
Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (6)
Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)
Measured: 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
Measured: 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
Measured: up to 12 months from Initiation of Hikma DMF
Time to First Relapse
Measured: 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
Measured: 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.
Measured: up to 12 months from Initiation of Hikma DMF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start23 Feb 2021
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468165
- Sponsor's protocol ID
- HIK-DMF-2020-01
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04468165
- Acronym / sponsor ID
- HIK-DMF-2020-01
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Dimethyl Fumarate, Generic Dimethyl Fumarate, Delayed-Release Dimethyl Fumarate, Disease Modifying Treatments, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA
Key inclusion criteria (6 listed)
- 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 :
- Patients who agree to participate in the study and provide a written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl Fumarate (DMF)Also: Sclera ®, Hikma, Marovarex ®, HikmaGastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate | Drug | – |
Primary outcome
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.
6 secondary outcomes
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
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
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
Time to First Relapse
Time frame: up to 12 months from Initiation of Hikma DMF
Proportion of patients with disability progression as measured by the EDSS over time
Time frame: up to 12 months from Initiation of Hikma DMF
Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time
Time frame: up to 12 months from Initiation of Hikma DMF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Hikma Pharmaceuticals LLC at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Egypt, Algeria, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.