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| Name | Class |
|---|---|
| Merck Serono Middle East FZ LLC | INDUSTRY |
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This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsing Multiple Sclerosis (RMS) group | Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif (Interferon beta-1a) | Drug | Rebif will be administered at a dose of 44 mcg, sc, tiw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score | MGLS is a four item self-reported questionnaire to assess medication adherence. It consists of four questions/items evaluating drug intake habits in subjects on chronic therapies with a scoring scheme of "Yes" = 1 (no adherence) and "No" = 0 (adherence). The items are summed to give an overall score, which ranges from 0 to 4 where high adherence=0, medium adherence=1-2 or low adherence=3-4. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects on Rebif who discontinued the treatment | up to 24 months | |
| Time to treatment discontinuation | up to 24 months | |
| Reason for treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Merck Serono Middle East FZ-LLC | an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Algiers | Algeria | ||||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38090266 | Derived | Al-Roughani R, Zakaria M, Cupler EJ, Taha K. Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. eCollection 2023. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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The reason for treatment discontinuation will includes: adverse event, lost to follow-up, lack of efficacy, protocol noncompliance, progressive disease, withdrew consent, death, frequency, unrealistic expectations, other |
| up to 24 months |
| Percentage of relapse-free subjects | Month 24 |
| Percentage of subjects with expanded disability status scale (EDSS) progression | EDSS is used for multiple sclerosis disability assessment. It is a 10 point scale, where 0 indicates normal motor skills, and 10 indicates patient's death. EDSS progression is defined as one point increase sustained for at least three months. | Month 24 |
| Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study | Up to 24 months |
| Percentage of relapse-free subjects based on MGLS Score | Up to 24 month |
| Annaba |
| Algeria |
| Research site | Blida | Algeria |
| Research site | Oran | Algeria |
| Research site | Sétif | Algeria |
| Research site | Tizi Ouzou | Algeria |
| Research site | Mendoza | Argentina |
| Research site | Rosario | Argentina |
| Research site | San Miguel de Tucumán | Argentina |
| Research site | Manama | Bahrain |
| Research site | Sofia | Bulgaria |
| Research site | Al Mansurah | Egypt |
| Research site | Alexandria | Egypt |
| Research site 1 | Cairo | Egypt |
| Research site 2 | Cairo | Egypt |
| Research site 1 | Budapest | Hungary |
| Research site 2 | Budapest | Hungary |
| Research site 3 | Budapest | Hungary |
| Research site | Esztergom | Hungary |
| Research site | Isfahan | Iran |
| Research site | Tehran | Iran |
| Research site | Kuwait City | Kuwait |
| Research site 1 | Beirut | Lebanon |
| Research site 2 | Beirut | Lebanon |
| Research site | Casablanca | Morocco |
| Research site | Fés | Morocco |
| Research site | Marrakesh | Morocco |
| Research site 1 | Rabat | Morocco |
| Research site 2 | Rabat | Morocco |
| Research site 3 | Rabat | Morocco |
| Research site | Gdansk | Poland |
| Research site | Katowice | Poland |
| Research site | Lodz | Poland |
| Research site | Lublin | Poland |
| Research site | Rybnik | Poland |
| Research site | Warsaw | Poland |
| Research site | Dammam | Saudi Arabia |
| Research site | Jeddah | Saudi Arabia |
| Research site | Khober | Saudi Arabia |
| Research site | Riyadh | Saudi Arabia |
| Research site 2 | Seoul | South Korea |
| Medical Information Location Map - Med Info Contacts | View source |
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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