NCT04468165

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

September 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

July 8, 2020

Last Update Submit

September 21, 2023

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Dimethyl FumarateGeneric Dimethyl FumarateDelayed-Release Dimethyl FumarateDisease Modifying TreatmentsNervous SystemMultiple SclerosisRelapsing-Remitting Multiple SclerosisCohort StudyObservational StudyEffectivenessSafetyHealth Related Quality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Secondary Outcomes (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

  • 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

  • +1 more secondary outcomes

Interventions

Dimethyl Fumarate (DMF)DRUG

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

Also known as: Sclera ®, Hikma, Marovarex ®, Hikma

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Frantz FANON

Blida, Algeria

Location

Nedir Mohamed Hospital

Tizi Ouzou, Algeria

Location

New University Hospital

Alexandria, Egypt

Location

Demerdash hospital (Ain Shams University)

Cairo, Egypt

Location

Private Clinic

Cairo, Egypt

Location

King Abdullah University Hospital (KAUH)

Ar Ramtha, Jordan

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingNeurologic ManifestationsMultiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

February 23, 2021

Primary Completion

July 20, 2023

Study Completion

July 20, 2023

Last Updated

September 22, 2023

Record last verified: 2023-03

Locations

EG(3)JO(1)AL(2)