Clinical trial NCT02921035: Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis (RMS)
Keywords: Relapsing Multiple Sclerosis
Interferon beta-1a
Rebif®
Morisky Green Levine Medication Adherence Scale
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Middle East FZ LLC
First posted: 2016-09-30
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
timeFrame: Month 24
Secondary outcomes:
measure: Percentage of subjects on Rebif who discontinued the treatment
timeFrame: up to 24 months
measure: Time to treatment discontinuation
timeFrame: up to 24 months
measure: Reason for treatment discontinuation
timeFrame: up to 24 months
measure: Percentage of relapse-free subjects
timeFrame: Month 24
measure: Percentage of subjects with expanded disability status scale (EDSS) progression
timeFrame: Month 24
measure: Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study
timeFrame: Up to 24 months
measure: Percentage of relapse-free subjects based on MGLS Score
timeFrame: Up to 24 month
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Research site
city: Annaba
country: Algeria
facility: Research site
city: Blida
country: Algeria
facility: Research site
city: Oran
country: Algeria
facility: Research site
city: Setif
country: Algeria
facility: Research site
city: Tizi Ouzou
country: Algeria
facility: Research site
city: Mendoza
country: Argentina
facility: Research site
city: Rosario
country: Argentina
facility: Research site
city: Tucuman
country: Argentina
facility: Research site
city: Manamah
country: Bahrain
facility: Research site
city: Sofia
country: Bulgaria
facility: Research site
city: Alexandria
country: Egypt
facility: Research site
city: Cairo
country: Egypt
facility: Research site 1
city: Cairo
country: Egypt
facility: Research site 2
city: Mansoura
country: Egypt
facility: Research site
city: Budapest
country: Hungary
facility: Research site 1
city: Budapest
country: Hungary
facility: Research site 2
city: Budapest
country: Hungary
facility: Research site 3
city: Esztergom
country: Hungary
facility: Research site
city: Isfahan
country: Iran, Islamic Republic of
facility: Research site
city: Tehran
country: Iran, Islamic Republic of
facility: Research site
city: Seoul
country: Korea, Republic of
facility: Research site 2
city: Kuwait
country: Kuwait
facility: Research site
city: Beirut
country: Lebanon
facility: Research site 1
city: Beirut
country: Lebanon
facility: Research site 2
city: Casablanca
country: Morocco
facility: Research site
city: Fés
country: Morocco
facility: Research site
city: Marrakech
country: Morocco
facility: Research site
city: Rabat
country: Morocco
facility: Research site 1
city: Rabat
country: Morocco
facility: Research site 2
city: Rabat
country: Morocco
facility: Research site 3
city: Gdańsk
country: Poland
facility: Research site
city: Katowice
country: Poland
facility: Research site
city: Lublin
country: Poland
facility: Research site
city: Rybnik
country: Poland
facility: Research site
city: Warszawa
country: Poland
facility: Research site
city: Łódź
country: Poland
facility: Research site
city: Dammam
country: Saudi Arabia
facility: Research site
city: Jeddah
country: Saudi Arabia
facility: Research site
city: Khober
country: Saudi Arabia
facility: Research site
city: Riyadh
country: Saudi Arabia
facility: Research site
Study officials:
affiliation: an affiliate of Merck KGaA, Darmstadt, Germany
name: Merck Serono Middle East FZ-LLC
role: STUDY_DIRECTOR
References: