Multiple SclerosisTOP MSNCT00819000
Therapy Optimization in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by Teva Neuroscience, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
- Type of treatment
- Injection or infusion
- How many people
- 2,878 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
Who may be able to join
- Male or female, 18 years of age or older, with a diagnosis of MS.
- Being treated with Glatiramer Acetate (GA) or (IFN)-β
- Receiving therapy from a participating Specialty Pharmacy
Who cannot join
- Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study
- Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP)
- Unlikely to be able to participate for the full two years of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Teva Investigational Site
Carnegie, Pennsylvania
Teva Investigational Site
Columbus, Ohio
Teva Investigational Site
Swartz Creek, Michigan
About this study
Official title: TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies
The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.
- Conditions
- Multiple Sclerosis
- Being tested
- Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
- Keywords
- Specialty Pharmacy, Therapy Management, Medication Compliance, Medication Adherence, Medication Persistence, Health Outcomes
- Medical subject headings
- Multiple Sclerosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1bDrug
Also called Copaxone®, Avonex®, Rebif®, Betaseron®
MS therapies (listed above) used according to prescribers' instructions.
| Study group | Role | What they receive |
|---|---|---|
| Treated MS Subjects | Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies Receives: Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes
Measured: 12 months and 24 months
Secondary outcomes (1)
Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MerriKay Oleen-Burkey, PhD, Study chair, Teva Neuroscience, Inc.Howard Zwibel, MD, Study director, Neurologic Center of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819000
- Sponsor's protocol ID
- PM032
- Acronym
- TOP MS
- Status last verified
- Jan 2013
- First submitted
- 7 Jan 2009
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H. Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse. Mult Scler Relat Disord. 2015 Jan;4(1):75-82. doi: 10.1016/j.msard.2014.09.214. Epub 2014 Oct 7.
PubMed 25787057Coyle PK, Cohen BA, Leist T, Markowitz C, Oleen-Burkey M, Schwartz M, Tullman MJ, Zwibel H. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes. BMC Neurol. 2014 Mar 13;14:49. doi: 10.1186/1471-2377-14-49.
PubMed 24624979
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies
- ClinicalTrials.gov ID
- NCT00819000
- Acronym / sponsor ID
- TOP MS / PM032
- Conditions
- Multiple Sclerosis
- Keywords
- Specialty Pharmacy, Therapy Management, Medication Compliance, Medication Adherence, Medication Persistence, Health Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jan 2009 (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 purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated MS Subjects | – | Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1bSubjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
Key inclusion criteria (3 listed)
- Male or female, 18 years of age or older, with a diagnosis of MS.
- Being treated with Glatiramer Acetate (GA) or (IFN)-β
- Receiving therapy from a participating Specialty Pharmacy
Key exclusion criteria (3 listed)
- Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study
- Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP)
- Unlikely to be able to participate for the full two years of 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 |
|---|---|---|
| Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1bAlso: Copaxone®, Avonex®, Rebif®, Betaseron®MS therapies (listed above) used according to prescribers' instructions. | Drug | Treated MS Subjects |
Primary outcome
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes
Time frame: 12 months and 24 months
1 secondary outcome
Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes
Time frame: 12 months and 24 months
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 29 Jan 2013.
- Derived from this study: PubMed 25787057Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H. Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse. Mult Scler Relat Disord. 2015 Jan;4(1):75-82. doi: 10.1016/j.msard.2014.09.214. Epub 2014 Oct 7.
- Derived from this study: PubMed 24624979Coyle PK, Cohen BA, Leist T, Markowitz C, Oleen-Burkey M, Schwartz M, Tullman MJ, Zwibel H. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes. BMC Neurol. 2014 Mar 13;14:49. doi: 10.1186/1471-2377-14-49.
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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.
MerriKay Oleen-Burkey, PhD study chair
Teva Neuroscience, Inc.
Howard Zwibel, MD study director
Neurologic Center of South Florida
3 sites 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, run by Teva Neuroscience, Inc. at 3 sites in United States.
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 3 inclusion and 3 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes (time frame: 12 months and 24 months). 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 NCT00819000, which also lists 2 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 29 Jan 2013.