Multiple Sclerosis, Relapsing RemittingSTARNCT01080027
Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
An observational study of Multiple Sclerosis, Relapsing Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
Trial summary
The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting
- What is being tested?
- Rebif® New Formulation
- Type of treatment
- Injection or infusion
- How many people
- 254 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2008to Jun 2011
- 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 diagnsoed with RRMS from approximately 80 sites across seven countries.
Who may be able to join
- Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)
- 18 to 60 years of age
- Expanded Disability Status Scale (EDSS) < 6
- Naïve subjects or subjects treated with Rebif® New Formulation for no more than 6 weeks prior to enrollment
- Subjects who have given written informed consent to participate in the study
Who cannot join
- Primary progressive or secondary progressive MS
- Subjects previously administered IFN beta-1a (including Rebif®) or IFN beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other MS therapy in the past with the exception of Rebif® New Formulation for no more than 6 weeks prior to enrollment
- Subjects receiving oral or systemic corticosteroids or Adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
- History of any chronic pain syndrome
- Known allergy to IFN or its excipients
- Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
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- Inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
- Inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
- Current or past (within the last 2 years) history of alcohol or drug abuse
- Contra-indications to IFN beta-1a
Trial locations and contacts
1 site in 1 country.
Greece1 site
Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
About this study
Official title: An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings
The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.
Read the detailed description
This international, multicentric, prospective, observational study is being conducted to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings in subjects with relapsing remitting multiple sclerosis (RRMS), as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. Three hundred and fifty subjects from approximately 80 sites across seven countries will be enrolled in the study. Subjects will be treated with IFN beta-1a (Rebif® New Formulation) in real life settings according to the clinical and paraclinical course and laboratory findings as routinely evaluated by the physician. Data related to AEs; subjects' adherence to treatment, reasons for treatment discontinuation; number and reasons of missed injections; and the clinical and paraclinical data on efficacy regarding relapses will be captured. Data will be reported prospectively throughout the duration of the study (12 months) at two visits (at month 6 and month 12) following the initial visit; at baseline, data can be recorded retrospectively from the subjects' medical file. All the data will be evaluated descriptively.
OBJECTIVES
Primary objective
- To assess the local tolerability of Rebif® New Formulation in real life settings with a multinational approach.
Secondary objectives
- To assess the safety profile, subjects' adherence to and efficacy of Rebif® New Formulation
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Being tested
- Rebif® New Formulation
- Keywords
- Multiple sclerosis, Relapsing remitting, Rebif
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif® New FormulationDrug
Also called Interferon beta1-A
The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with injection site reactions (ISRs)
Measured: Baseline, month 6 and month 12
Secondary outcomes (1)
proportion of subjects with AEs and with specific categories of AEs; proportion and reasons of missed injections, annual relapse rate, proportion of relapse-free subjects from baseline, time to first relapse
Measured: Baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
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 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck A.E., Greece, Merck OY, Finland, Merck B.V., Netherlands, Merck A.B., Sweden, Merck, S.A., Portugal
- Responsible party
- Sponsor
- Investigators
- Michalis Arvanitis, MD, MSc, Study director, Merck A.E., Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080027
- Sponsor's protocol ID
- EMR 701068_506
- Acronym
- STAR
- Status last verified
- Jul 2014
- First submitted
- 2 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
Publications
Hupperts R, Ghazi-Visser L, Martins Silva A, Arvanitis M, Kuusisto H, Marhardt K, Vlaikidis N; STAR Study Group. The STAR Study: a real-world, international, observational study of the safety and tolerability of, and adherence to, serum-free subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis. Clin Ther. 2014 Dec 1;36(12):1946-1957. doi: 10.1016/j.clinthera.2014.04.002. Epub 2014 May 5.
PubMed 24811754
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings
- ClinicalTrials.gov ID
- NCT01080027
- Acronym / sponsor ID
- STAR / EMR 701068_506
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Keywords
- Multiple sclerosis, Relapsing remitting, Rebif
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck A.E., Greece, Merck OY, Finland, Merck B.V., Netherlands, Merck A.B., Sweden, Merck, S.A., Portugal
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Mar 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 rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.
Detailed description
This international, multicentric, prospective, observational study is being conducted to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings in subjects with relapsing remitting multiple sclerosis (RRMS), as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. Three hundred and fifty subjects from approximately 80 sites across seven countries will be enrolled in the study. Subjects will be treated with IFN beta-1a (Rebif® New Formulation) in real life settings according to the clinical and paraclinical course and laboratory findings as routinely evaluated by the physician. Data related to AEs; subjects' adherence to treatment, reasons for treatment discontinuation; number and reasons of missed injections; and the clinical and paraclinical data on efficacy regarding relapses will be captured. Data will be reported prospectively throughout the duration of the study (12 months) at two visits (at month 6 and month 12) following the initial visit; at baseline, data can be recorded retrospectively from the subjects' medical file. All the data will be evaluated descriptively.
OBJECTIVES
Primary objective
- To assess the local tolerability of Rebif® New Formulation in real life settings with a multinational approach.
Secondary objectives
- To assess the safety profile, subjects' adherence to and efficacy of Rebif® New Formulation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects diagnsoed with RRMS from approximately 80 sites across seven countries.
Key inclusion criteria (5 listed)
- Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)
- 18 to 60 years of age
- Expanded Disability Status Scale (EDSS) < 6
- Naïve subjects or subjects treated with Rebif® New Formulation for no more than 6 weeks prior to enrollment
- Subjects who have given written informed consent to participate in the study
Key exclusion criteria (10 listed)
- Primary progressive or secondary progressive MS
- Subjects previously administered IFN beta-1a (including Rebif®) or IFN beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other MS therapy in the past with the exception of Rebif® New Formulation for no more than 6 weeks prior to enrollment
- Subjects receiving oral or systemic corticosteroids or Adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
- History of any chronic pain syndrome
- Known allergy to IFN or its excipients
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® New FormulationAlso: Interferon beta1-AThe recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection. | Drug | – |
Primary outcome
Proportion of subjects with injection site reactions (ISRs)
Time frame: Baseline, month 6 and month 12
1 secondary outcome
proportion of subjects with AEs and with specific categories of AEs; proportion and reasons of missed injections, annual relapse rate, proportion of relapse-free subjects from baseline, time to first relapse
Time frame: Baseline, month 6 and month 12
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 31 Jul 2014.
- Derived from this study: PubMed 24811754Hupperts R, Ghazi-Visser L, Martins Silva A, Arvanitis M, Kuusisto H, Marhardt K, Vlaikidis N; STAR Study Group. The STAR Study: a real-world, international, observational study of the safety and tolerability of, and adherence to, serum-free subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis. Clin Ther. 2014 Dec 1;36(12):1946-1957. doi: 10.1016/j.clinthera.2014.04.002. Epub 2014 May 5.
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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, MSc 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 5 inclusion and 10 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 31 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?
Proportion of subjects with injection site reactions (ISRs) (time frame: Baseline, month 6 and month 12). 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 NCT01080027, 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 31 Jul 2014.