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

March 22, 2022 updated by: Merck KGaA, Darmstadt, Germany

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

594

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Alger, Algeria
        • Research Site
      • Annaba, Algeria
        • Research Site
      • Blida, Algeria
        • Research Site
      • Oran, Algeria
        • Research Site
      • Setif, Algeria
        • Research Site
      • Tizi Ouzou, Algeria
        • Research Site
  • Argentina
      • Mendoza, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Tucuman, Argentina
        • Research Site
  • Bahrain
      • Manamah, Bahrain
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria
        • Research Site
  • Egypt
      • Alexandria, Egypt
        • Research Site
      • Cairo, Egypt
        • Research Site 1
      • Cairo, Egypt
        • Research Site 2
      • Mansoura, Egypt
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site 1
      • Budapest, Hungary
        • Research Site 2
      • Budapest, Hungary
        • Research Site 3
      • Esztergom, Hungary
        • Research Site
  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of
        • Research Site
      • Tehran, Iran, Islamic Republic of
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site 2
  • Kuwait
      • Kuwait, Kuwait
        • Research Site
  • Lebanon
      • Beirut, Lebanon
        • Research Site 1
      • Beirut, Lebanon
        • Research Site 2
  • Morocco
      • Casablanca, Morocco
        • Research Site
      • Fés, Morocco
        • Research Site
      • Marrakech, Morocco
        • Research Site
      • Rabat, Morocco
        • Research Site 1
      • Rabat, Morocco
        • Research Site 2
      • Rabat, Morocco
        • Research Site 3
  • Poland
      • Gdańsk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Rybnik, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • Saudi Arabia
      • Dammam, Saudi Arabia
        • Research Site
      • Jeddah, Saudi Arabia
        • Research Site
      • Khober, Saudi Arabia
        • Research Site
      • Riyadh, Saudi Arabia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
Time Frame: 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.
Month 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Middle East FZ LLC

Investigators

  • Study Director: Merck Serono Middle East FZ-LLC, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

July 27, 2020

Study Completion (Actual)

July 27, 2020

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS200136_0035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Multiple Sclerosis (RMS)

Clinical Trials on Rebif (Interferon beta-1a)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe