Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)
1 other identifier
observational
594
13 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Longer than P75 for all trials
41 active sites
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
Study Start
First participant enrolled
June 30, 2016
CompletedFirst Submitted
Initial submission to the registry
September 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2020
CompletedApril 4, 2022
March 1, 2022
4.1 years
September 29, 2016
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
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
up to 24 months
Percentage of relapse-free subjects
Month 24
Percentage of subjects with expanded disability status scale (EDSS) progression
Month 24
- +2 more secondary outcomes
Study Arms (1)
Relapsing Multiple Sclerosis (RMS) group
Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)
Interventions
Rebif will be administered at a dose of 44 mcg, sc, tiw.
Eligibility Criteria
Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck KGaA, Darmstadt, Germanylead
- Merck Serono Middle East FZ LLCcollaborator
Study Sites (41)
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
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
Related Publications (1)
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.
PMID: 38090266DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Merck Serono Middle East FZ-LLC
an affiliate of Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2016
First Posted
September 30, 2016
Study Start
June 30, 2016
Primary Completion
July 27, 2020
Study Completion
July 27, 2020
Last Updated
April 4, 2022
Record last verified: 2022-03