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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Serono Middle East FZ LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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