Multiple SclerosisNCT00238654
A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
An observational study of Multiple Sclerosis, run by Teva Neuroscience, Inc..
Trial summary
This study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jul 2008
- 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: RRMS patient with treatment-naïve or treatment-experienced
Who may be able to join
- Male or Female, 18 years of age or older, with diagnosis of RRMS
- Naive to treatment or previously treated with an IFN.
Who cannot join
- Not eligible for treatment based on clinical criteria and current indication.
- Unable to respond to surveys or provide informed consent.
About this study
Official title: A Multicenter, Open-Label, Two-Arm Prospective Study to Evaluate the Impact of Patient Readiness to Self-Inject on Outcomes When Using the Copaxone® Prefilled Syringes [The "READY" Trial]
This study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence of self-injection assessed by self-report at each follow-up visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startMay 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MerriKay Oleen-Burkey, Ph.D., Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238654
- Sponsor's protocol ID
- PM08
- Status last verified
- Apr 2011
- First submitted
- 12 Oct 2005
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Two-Arm Prospective Study to Evaluate the Impact of Patient Readiness to Self-Inject on Outcomes When Using the Copaxone® Prefilled Syringes [The "READY" Trial]
- ClinicalTrials.gov ID
- NCT00238654
- Acronym / sponsor ID
- PM08
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Oct 2005 (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 study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RRMS patient with treatment-naïve or treatment-experienced
Key inclusion criteria (2 listed)
- Male or Female, 18 years of age or older, with diagnosis of RRMS
- Naive to treatment or previously treated with an IFN.
Key exclusion criteria (2 listed)
- Not eligible for treatment based on clinical criteria and current indication.
- Unable to respond to surveys or provide informed consent.
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
Adherence of self-injection assessed by self-report at each follow-up visit
Time frame: 12 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 12 Apr 2011.
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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, Ph.D. study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Teva Neuroscience, Inc..
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 2 inclusion and 2 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 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Adherence of self-injection assessed by self-report at each follow-up visit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2011.