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Completed

NCT Number: NCT02921035

Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (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.

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Key information

Conditions

Relapsing Multiple Sclerosis (RMS)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site, Algiers, Algeria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rebif (Interferon beta-1a)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of subjects on Rebif who discontinued the treatment

    Time frame: up to 24 months

  2. Time to treatment discontinuation

    Time frame: up to 24 months

  3. 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

  4. Percentage of relapse-free subjects

    Time frame: Month 24

  5. 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.

  6. 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

  7. Percentage of relapse-free subjects based on MGLS Score

    Time frame: Up to 24 month

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Middle East FZ LLC

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2016
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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