Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

Merck KGaA, Darmstadt, Germany594 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

594

Conditions

Relapsing Multiple Sclerosis (RMS)

Interventions

Rebif (Interferon beta-1a)DRUG

Rebif will be administered at a dose of 44 mcg, sc, tiw.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects aged more than or equal to (\>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction * Subjects diagnosed with RMS according to the revised McDonald criteria (2010) * Treatment naïve or subjects on other DMDs who will switch to Rebif. * Subjects will receive 1st Rebif 44 mcg dose after signing informed consent * Subjects willing and able to provide signed informed consent. Exclusion Criteria: * Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information * Subjects participating in other clinical studies/trials * Any female subject of childbearing potential who is not on contraceptives * Subjects refusal to participate in the study.

Locations (41)

Outcomes

Primary Outcomes

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.

Time frame: Month 24

Secondary Outcomes

Percentage of subjects on Rebif who discontinued the treatment

Time frame: up to 24 months

Time to treatment discontinuation

Time frame: up to 24 months

Reason for treatment discontinuation

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

Time frame: up to 24 months

Percentage of relapse-free subjects

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research site

Algiers, Algeria

Research site

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

...and 31 more locations