Relapsing Multiple Sclerosis (RMS)NCT02921035
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
An observational study of Relapsing Multiple Sclerosis (RMS), run by Merck KGaA, Darmstadt, Germany at 41 sites in 13 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis (RMS)
- What is being tested?
- Rebif (Interferon beta-1a)
- How many people
- 594 participants
- Where
- 41 sitesin 13 countries
- Study dates
- 30 Jun 2016to 27 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 13 countries.
41 sites in 13 countries
Algeria6 sites
Research site
Algiers
Research site
Annaba
Research site
Blida
Research site
Oran
Research site
Sétif
Research site
Tizi Ouzou
Morocco6 sites
Research site
Casablanca
Research site
Fés
Research site
Marrakesh
Research site 1
Rabat
Research site 2
Rabat
Research site 3
Rabat
Poland6 sites
Research site
Gdansk
Research site
Katowice
Research site
Lodz
Research site
Lublin
Research site
Rybnik
Research site
Warsaw
Egypt4 sites
Research site
Al Mansurah
Research site
Alexandria
Research site 1
Cairo
Research site 2
Cairo
Hungary4 sites
Research site 1
Budapest
Research site 2
Budapest
Research site 3
Budapest
Research site
Esztergom
Saudi Arabia4 sites
Research site
Dammam
Research site
Jeddah
Research site
Khober
Research site
Riyadh
Argentina3 sites
Research site
Mendoza
Research site
Rosario
Research site
San Miguel de Tucumán
About this study
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)
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.
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Being tested
- Rebif (Interferon beta-1a)
- Keywords
- Relapsing Multiple Sclerosis, Interferon beta-1a, Rebif®, Morisky Green Levine Medication Adherence Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif (Interferon beta-1a)Drug
Rebif will be administered at a dose of 44 mcg, sc, tiw.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Multiple Sclerosis (RMS) group | Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a) Receives: Drug: Rebif (Interferon beta-1a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 24
Secondary outcomes (7)
Percentage of subjects on Rebif who discontinued the treatment
Measured: up to 24 months
Time to treatment discontinuation
Measured: up to 24 months
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
Measured: up to 24 months
Percentage of relapse-free subjects
Measured: Month 24
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.
Measured: 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
Measured: Up to 24 months
Percentage of relapse-free subjects based on MGLS Score
Measured: Up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start30 Jun 2016
- Primary completion27 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Multiple Sclerosis (RMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Middle East FZ LLC
- Responsible party
- Sponsor
- Investigators
- Merck Serono Middle East FZ-LLC, Study director, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921035
- Sponsor's protocol ID
- MS200136_0035
- Status last verified
- Mar 2022
- First submitted
- 29 Sep 2016
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Roughani R, Zakaria M, Cupler EJ, Taha K. Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. eCollection 2023.
PubMed 38090266
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02921035
- Acronym / sponsor ID
- MS200136_0035
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Keywords
- Relapsing Multiple Sclerosis, Interferon beta-1a, Rebif®, Morisky Green Levine Medication Adherence Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Middle East FZ LLC
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Multiple Sclerosis (RMS) group | – | Drug: Rebif (Interferon beta-1a)Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebif (Interferon beta-1a)Rebif will be administered at a dose of 44 mcg, sc, tiw. | Drug | Relapsing Multiple Sclerosis (RMS) group |
Primary outcome
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.
7 secondary outcomes
Percentage of subjects on Rebif who discontinued the treatment
Time frame: up to 24 months
Time to treatment discontinuation
Time frame: up to 24 months
Reason for treatment discontinuation
Time frame: up to 24 months
Percentage of relapse-free subjects
Time frame: Month 24
Percentage of subjects with expanded disability status scale (EDSS) progression
Time frame: 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
Percentage of relapse-free subjects based on MGLS Score
Time frame: Up to 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 38090266Al-Roughani R, Zakaria M, Cupler EJ, Taha K. Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. eCollection 2023.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merck Serono Middle East FZ-LLC study director
an affiliate of Merck KGaA, Darmstadt, Germany
41 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis (RMS), run by Merck KGaA, Darmstadt, Germany at 41 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Algeria, Morocco, Poland, Egypt, Hungary and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.