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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT02921035

Collaborator

Merck Serono Middle East FZ LLC (Industry)

594

Enrollment

Locations

48.9

Actual Duration (Months)

14.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Multiple Sclerosis (RMS)	Drug: Rebif (Interferon beta-1a)

Study Design

Study Type:

Observational

Actual Enrollment :

594 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jun 30, 2016

Actual Primary Completion Date :

Jul 27, 2020

Actual Study Completion Date :

Jul 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Relapsing Multiple Sclerosis (RMS) group Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)	Drug: Rebif (Interferon beta-1a) Rebif will be administered at a dose of 44 mcg, sc, tiw.

Arm

Intervention/Treatment

Relapsing Multiple Sclerosis (RMS) group

Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)

Drug: Rebif (Interferon beta-1a)

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

Outcome Measures

Primary Outcome Measures

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

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]
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 relapse-free subjects [Month 24]
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Research site	Alger	Algeria
2	Research site	Annaba	Algeria
3	Research site	Blida	Algeria
4	Research site	Oran	Algeria
5	Research site	Setif	Algeria
6	Research site	Tizi Ouzou	Algeria
7	Research site	Mendoza	Argentina
8	Research site	Rosario	Argentina
9	Research site	Tucuman	Argentina
10	Research site	Manamah	Bahrain
11	Research site	Sofia	Bulgaria
12	Research site	Alexandria	Egypt
13	Research site 1	Cairo	Egypt
14	Research site 2	Cairo	Egypt
15	Research site	Mansoura	Egypt
16	Research site 1	Budapest	Hungary
17	Research site 2	Budapest	Hungary
18	Research site 3	Budapest	Hungary
19	Research site	Esztergom	Hungary
20	Research site	Isfahan	Iran, Islamic Republic of
21	Research site	Tehran	Iran, Islamic Republic of
22	Research site 2	Seoul	Korea, Republic of
23	Research site	Kuwait	Kuwait
24	Research site 1	Beirut	Lebanon
25	Research site 2	Beirut	Lebanon
26	Research site	Casablanca	Morocco
27	Research site	Fés	Morocco
28	Research site	Marrakech	Morocco
29	Research site 1	Rabat	Morocco
30	Research site 2	Rabat	Morocco
31	Research site 3	Rabat	Morocco
32	Research site	Gdańsk	Poland
33	Research site	Katowice	Poland
34	Research site	Lublin	Poland
35	Research site	Rybnik	Poland
36	Research site	Warszawa	Poland
37	Research site	Łódź	Poland
38	Research site	Dammam	Saudi Arabia
39	Research site	Jeddah	Saudi Arabia
40	Research site	Khober	Saudi Arabia
41	Research site	Riyadh	Saudi Arabia