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

Completed

• Conditions: Relapsing Multiple Sclerosis (RMS)
• Interventions: Drug: Rebif (Interferon beta-1a)

• Registration Number: NCT02921035
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-30
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2020-07-27
• Study Completion: 2020-07-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsing Multiple Sclerosis (RMS) group	Rebif (Interferon beta-1a)	Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)

Primary Outcome Measures

Name	Time	Method
Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score	Month 24	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of relapse-free subjects	Month 24
Percentage of relapse-free subjects based on MGLS Score	Up to 24 month
Percentage of subjects on Rebif who discontinued the treatment	up to 24 months
Time to treatment discontinuation	up to 24 months
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
Reason for treatment discontinuation	up to 24 months	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
Percentage of subjects with expanded disability status scale (EDSS) progression	Month 24	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.

Trial Locations

Locations (4)

Research site; 🇸🇦 Riyadh, Saudi Arabia

Research site 2; 🇲🇦 Rabat, Morocco

Research site 3; 🇲🇦 Rabat, Morocco

Research site 1; 🇲🇦 Rabat, Morocco