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

Hikma

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Dimethyl Fumarate (DMF)

Study type: Observational

Funder types: Industry

Identifiers

NCT04468165

HIK-DMF-2020-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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