An observational study in Relapsing Remitting Multiple Sclerosis, sponsored by Hikma Pharmaceuticals LLC. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Hikma Pharmaceuticals LLC · Observational
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
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 160 is above the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Hikma Pharmaceuticals LLC is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
Also known as: Sclera ®, Hikma, Marovarex ®, Hikma
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.
Time frame: 12 Months
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
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
Time frame: 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.
Time frame: up to 12 months from Initiation of Hikma DMF
Ran from Feb 2021 to primary completion in Jul 2023, 28 months.
Of 26 industry-sponsored observational studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's 28 months is close to that.
Counting every sponsor, half of 67 studies reached it within 41 months; a quarter within 23 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting →