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

Relapsing Multiple Sclerosis (RMS) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921035
• Other study ID #: MS200136_0035
• Status: Completed
• Start date: June 30, 2016
• Est. completion date: July 27, 2020

Study information

• Verified date: March 2022
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis (RMS)
• Sclerosis

Intervention

Drug:
• Rebif (Interferon beta-1a)
Rebif will be administered at a dose of 44 mcg, sc, tiw.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Merck Serono Middle East FZ LLC

Countries where clinical trial is conducted

Algeria,  Argentina,  Bahrain,  Bulgaria,  Egypt,  Hungary,  Iran, Islamic Republic of,  Korea, Republic of,  Kuwait,  Lebanon,  Morocco,  Poland,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score	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	Percentage of subjects on Rebif who discontinued the treatment		up to 24 months
Secondary	Time to treatment discontinuation		up to 24 months
Secondary	Reason for treatment discontinuation	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
Secondary	Percentage of relapse-free subjects		Month 24
Secondary	Percentage of subjects with expanded disability status scale (EDSS) progression	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
Secondary	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
Secondary	Percentage of relapse-free subjects based on MGLS Score		Up to 24 month

External Links

•   Trial Awareness and Transparency website