Multiple Sclerosis, Relapsing-RemittingNCT01112345
An Observational Study for the Assessment of Compliance and Persistence to Rebif® Therapy of Patients With Relapsing-remitting Multiple Sclerosis (MS) and Evaluation of Potential Factors Influencing These Parameters
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
Trial summary
The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 133 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2009to Sep 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with documented diagnosis of RRMS according to the McDonald criteria (2005)
Who may be able to join
- Subjects with documented diagnosis of RRMS according to the Mc Donald criteria (2005)
- Subjects who have already been administered therapy with IFN b-1a (Rebif) according to the approved product's Summary of Product Characteristics (SPC), at least two weeks and not longer than six weeks prior to their enrolment into the study
- Subjects of both genders, aged between 18 - 65 years (inclusive)
- Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at baseline (before Rebif therapy initiation)
- Subjects who are able to read and understand the Patient Information Leaflet
- Subjects who have signed the Informed Consent Form
- Subjects who are willing and capable to comply will all study requirements and procedures.
Who cannot join
- Subjects that meet any of the contraindications to the administration of the study drug according to the approved SPC
- Subjects with primary progressive or secondary progressive form of MS
- Subjects who have been treated with Rebif for less than two weeks and more than six weeks before their enrollment into the study
- Subjects who had been receiving any therapy for MS (other disease modifying drugs, immunomodulatory and/or immunosuppressive agents) within three months before Rebif therapy commencement
- History of any chronic pain syndrome
- Current or past (during the preceding two years) history of alcohol or drug abuse
- Women who are pregnant or breastfeeding or of childbearing potential that do not use any medically accepted method of contraception
- Subjects who are currently participating or had participated in another clinical trial during the last three months prior to their enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Non Interventional, Non Randomized, Observational Study for the Assessment of Compliance and Persistence With Rebif® Therapy of Patients With Relapsing-Remitting Multiple Sclerosis as Well as for the Evaluation of Potential Factors Influencing These Parameters, in Real Life Clinical Practice
The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions.
Read the detailed description
In the relapsing-remitting type of the disease the objective of the therapy is the reduction of relapse rate, duration and severity, as well as the delay of transition to the progressive form of the disease. Subjects' adherence to long-term therapy of MS plays a pivotal role in the optimization of therapeutic outcome and maximization of the derived clinical benefit for the treated subjects. Rebif current formulation has been developed by assessing and refining the physicochemical characteristics of existing formulations aiming at further improving product's tolerability profile. Studies performed for the assessment of Rebif have demonstrated a 3-fold reduction in injection site reactions as well as improved overall tolerability and safety profile.
This is a multicentre, prospective, non interventional, non randomized, open label study for the assessment of the adherence to therapy with Rebif of subjects with RRMS. The participating subjects shall be already on treatment with (Rebif) prior to their enrolment into the study, according to the approved Summary of Product Characteristics (SPC) and the clinical, imaging and laboratory findings of the disease, as evaluated by their treating physician, in real life clinical practice. Data will be collected retrospectively from a sample of 150 subjects' medical files and through questions that will be posed to the subjects, and prospectively during the course of the study. The total duration of the study is estimated to be 18 months.
OBJECTIVES
Primary objective:
- To assess the compliance and persistence with Rebif therapy in MS subjects, after six months of therapy, in "real life" clinical settings in Greece
Secondary objective:
- To investigate the potential factors influencing compliance and persistence to Rebif therapy.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Interferon-beta
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment
Evaluation of the actual number of injections administered during the preceding 2 weeks prior to subjects' enrolment into the study
Measured: Preceding 2 weeks prior to subjects enrolment into the study
Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment after 6 months of therapy
Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study
Measured: From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study
Assessment of subjects' persistence to therapy
Assessment will include recording of the number of days under treatment since subjects' enrolment into the study and until the performance of the study final visit, at Month 6.
Measured: Since subjects' enrolment until final study visit (Month 6)
Secondary outcomes (1)
Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy
Subject's training regarding proper administration of the study drug and proper use of auto-injector of the study drug (Rebiject II); implementation by subject of the recommendations for treatment administration and instructions on the proper use of device (via prefilled syringe or auto-injector); prophylactic use of non steroidal anti-inflammatory drugs (NSAIDs); reasons for missed injections; EDSS score at baseline; relapse history prior to Rebif therapy initiation; MS treatments received by the subject during the preceding year before Rebif therapy commencement
Measured: Subjects' enrollment to final study visit (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck A.E., Greece
- Responsible party
- Sponsor
- Investigators
- Michalis Arvanitis, MD, Study director, Merck A.E., Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112345
- Sponsor's protocol ID
- EMR 701068-513
- Status last verified
- Jul 2014
- First submitted
- 26 Apr 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
Publications
Manfredonia F, Pasquali L, Dardano A, Iudice A, Murri L, Monzani F. Review of the clinical evidence for interferon beta 1a (Rebif) in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2008 Apr;4(2):321-36. doi: 10.2147/ndt.s476.
PubMed 18728744Murdoch D, Lyseng-Williamson KA. Subcutaneous recombinant interferon-beta-1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs. 2005;65(9):1295-312. doi: 10.2165/00003495-200565090-00010.
PubMed 15916455Gold R, Rieckmann P, Chang P, Abdalla J; PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005 Aug;12(8):649-56. doi: 10.1111/j.1468-1331.2005.01083.x.
PubMed 16053475Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand. 2006 Mar;113(3):156-62. doi: 10.1111/j.1600-0404.2005.00568.x.
PubMed 16441244
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Non Interventional, Non Randomized, Observational Study for the Assessment of Compliance and Persistence With Rebif® Therapy of Patients With Relapsing-Remitting Multiple Sclerosis as Well as for the Evaluation of Potential Factors Influencing These Parameters, in Real Life Clinical Practice
- ClinicalTrials.gov ID
- NCT01112345
- Acronym / sponsor ID
- EMR 701068-513
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Interferon-beta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck A.E., Greece
- Study start
- Dec 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Apr 2010 (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.
The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions.
Detailed description
In the relapsing-remitting type of the disease the objective of the therapy is the reduction of relapse rate, duration and severity, as well as the delay of transition to the progressive form of the disease. Subjects' adherence to long-term therapy of MS plays a pivotal role in the optimization of therapeutic outcome and maximization of the derived clinical benefit for the treated subjects. Rebif current formulation has been developed by assessing and refining the physicochemical characteristics of existing formulations aiming at further improving product's tolerability profile. Studies performed for the assessment of Rebif have demonstrated a 3-fold reduction in injection site reactions as well as improved overall tolerability and safety profile.
This is a multicentre, prospective, non interventional, non randomized, open label study for the assessment of the adherence to therapy with Rebif of subjects with RRMS. The participating subjects shall be already on treatment with (Rebif) prior to their enrolment into the study, according to the approved Summary of Product Characteristics (SPC) and the clinical, imaging and laboratory findings of the disease, as evaluated by their treating physician, in real life clinical practice. Data will be collected retrospectively from a sample of 150 subjects' medical files and through questions that will be posed to the subjects, and prospectively during the course of the study. The total duration of the study is estimated to be 18 months.
OBJECTIVES
Primary objective:
- To assess the compliance and persistence with Rebif therapy in MS subjects, after six months of therapy, in "real life" clinical settings in Greece
Secondary objective:
- To investigate the potential factors influencing compliance and persistence to Rebif therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with documented diagnosis of RRMS according to the McDonald criteria (2005)
Key inclusion criteria (7 listed)
- Subjects with documented diagnosis of RRMS according to the Mc Donald criteria (2005)
- Subjects who have already been administered therapy with IFN b-1a (Rebif) according to the approved product's Summary of Product Characteristics (SPC), at least two weeks and not longer than six weeks prior to their enrolment into the study
- Subjects of both genders, aged between 18 - 65 years (inclusive)
- Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at baseline (before Rebif therapy initiation)
- Subjects who are able to read and understand the Patient Information Leaflet
Key exclusion criteria (8 listed)
- Subjects that meet any of the contraindications to the administration of the study drug according to the approved SPC
- Subjects with primary progressive or secondary progressive form of MS
- Subjects who have been treated with Rebif for less than two weeks and more than six weeks before their enrollment into the study
- Subjects who had been receiving any therapy for MS (other disease modifying drugs, immunomodulatory and/or immunosuppressive agents) within three months before Rebif therapy commencement
- History of any chronic pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment
Time frame: Preceding 2 weeks prior to subjects enrolment into the study
Evaluation of the actual number of injections administered during the preceding 2 weeks prior to subjects' enrolment into the study
Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment after 6 months of therapy
Time frame: From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study
Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study
Assessment of subjects' persistence to therapy
Time frame: Since subjects' enrolment until final study visit (Month 6)
Assessment will include recording of the number of days under treatment since subjects' enrolment into the study and until the performance of the study final visit, at Month 6.
1 secondary outcome
Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy
Time frame: Subjects' enrollment to final study visit (Month 6)
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 16 Jul 2014.
- Background: PubMed 18728744Manfredonia F, Pasquali L, Dardano A, Iudice A, Murri L, Monzani F. Review of the clinical evidence for interferon beta 1a (Rebif) in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2008 Apr;4(2):321-36. doi: 10.2147/ndt.s476.
- Background: PubMed 15916455Murdoch D, Lyseng-Williamson KA. Subcutaneous recombinant interferon-beta-1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs. 2005;65(9):1295-312. doi: 10.2165/00003495-200565090-00010.
- Background: PubMed 16053475Gold R, Rieckmann P, Chang P, Abdalla J; PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005 Aug;12(8):649-56. doi: 10.1111/j.1468-1331.2005.01083.x.
- Background: PubMed 16441244Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand. 2006 Mar;113(3):156-62. doi: 10.1111/j.1600-0404.2005.00568.x.
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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.
Michalis Arvanitis, MD study director
Merck A.E., Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
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 7 inclusion and 8 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment (time frame: Preceding 2 weeks prior to subjects enrolment into the study). The study lists 3 primary outcomes in all. 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 NCT01112345, which also lists 4 linked publications.
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 16 Jul 2014.