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
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| ClinicalTrials.gov Identifier: NCT01112345 |
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Recruitment Status :
Completed
First Posted : April 28, 2010
Last Update Posted : July 16, 2014
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| Condition or disease |
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| Multiple Sclerosis, Relapsing-Remitting |
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 Type : | Observational |
| Actual Enrollment : | 133 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2012 |
- 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.
- 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) ]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
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112345
| Greece | |
| Henry Dunant Hospital - IRB | |
| Athens, Greece, 11526 | |
| Study Director: | Michalis Arvanitis, MD | Merck A.E., Greece |
Publications:
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01112345 History of Changes |
| Other Study ID Numbers: |
EMR 701068-513 |
| First Posted: | April 28, 2010 Key Record Dates |
| Last Update Posted: | July 16, 2014 |
| Last Verified: | July 2014 |
Keywords provided by Merck KGaA:
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Multiple Sclerosis, Relapsing-Remitting Interferon-beta |
Additional relevant MeSH terms:
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Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |