Multiple Sclerosis, Relapsing-RemittingCOMPASSNCT00675883
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in Canada.
Trial summary
A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients… 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
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in the MS AllianceTM program
Who may be able to join
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, London Health Sciences Centre
London, Ontario
About this study
A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients enrolled in this program prior to October 2007.
Read the detailed description
Study Design
Five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive AVONEX. Patients will join the study by signing the attached Informed Consent Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. Once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject.
In the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the MS Alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period.
Study Objectives
Primary Objectives:
- To assess patients' compliance (as defined above) with AVONEX therapy in the prospective arm using self-reported patients questionnaire, as well as to compare patients' persistence on therapy (as defined above) between prospective and retrospective arms.
Secondary Objective:
- Evaluate patients' satisfaction with new MSA program.
Patients and Methods
Only patients enrolled in the MSA program will be included in this study. There will be no interventions above the current standard of care with the MSA program. Two distinct patient arms will exist for this study: the prospective arm and the retrospective (chart review) arm.
Inclusion Criteria
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | 500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study. | |
| Retrospective | 500 patient chart reviews will be completed for patients who were enrolled in the MS Alliance program between two (2) to three (3) years ago. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with therapy in the prospective arm
Measured: Week 7-10 and Week 80-83
Persistence on therapy between prospective and retrospective arms
Measured: 22 months
Secondary outcomes (1)
Patients' satisfaction with new MSA program
Measured: Week 7-10 and Week 80-83
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675883
- Sponsor's protocol ID
- AVX-CAN-0703
- Acronym
- COMPASS
- Status last verified
- Jan 2012
- First submitted
- 8 May 2008
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
- ClinicalTrials.gov ID
- NCT00675883
- Acronym / sponsor ID
- COMPASS / AVX-CAN-0703
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 May 2008 (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.
A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients enrolled in this program prior to October 2007.
Detailed description
Study Design
Five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive AVONEX. Patients will join the study by signing the attached Informed Consent Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. Once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject.
In the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the MS Alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period.
Study Objectives
Primary Objectives:
- To assess patients' compliance (as defined above) with AVONEX therapy in the prospective arm using self-reported patients questionnaire, as well as to compare patients' persistence on therapy (as defined above) between prospective and retrospective arms.
Secondary Objective:
- Evaluate patients' satisfaction with new MSA program.
Patients and Methods
Only patients enrolled in the MSA program will be included in this study. There will be no interventions above the current standard of care with the MSA program. Two distinct patient arms will exist for this study: the prospective arm and the retrospective (chart review) arm.
Inclusion Criteria
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | –500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study. |
| Retrospective | – | –500 patient chart reviews will be completed for patients who were enrolled in the MS Alliance program between two (2) to three (3) years ago. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in the MS AllianceTM program
Key inclusion criteria (3 listed)
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
Key exclusion criteria (0 listed)
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
Compliance with therapy in the prospective arm
Time frame: Week 7-10 and Week 80-83
Persistence on therapy between prospective and retrospective arms
Time frame: 22 months
1 secondary outcome
Patients' satisfaction with new MSA program
Time frame: Week 7-10 and Week 80-83
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 30 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biogen at 1 site in Canada.
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 0 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 30 Jan 2012. 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 Canada. 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?
Compliance with therapy in the prospective arm (time frame: Week 7-10 and Week 80-83). The study lists 2 primary outcomes in all. 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 30 Jan 2012.