Relapsing-Remitting Multiple SclerosisCOSTANNCT01706107
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 11 sites in Canada.
Trial summary
The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- How many people
- 73 participants
- Where
- 11 sitesCanada
- Study dates
- 7 Nov 2012to 2 Oct 2015
- 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 who choose to participate in the study will receive a thorough description of the study protocol and an informed consent document describing the study and the risks and benefits of participating. Recruitment will continue until approximately 150 patients have been enrolled in the study at approximately 15 sites across Canada.
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
- Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
- Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
- Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
- Decision to treat with Tysabri must precede enrollment.
Who cannot join
- Any prior treatment with Tysabri.
- Contraindications to treatment with Tysabri as described in the Product Monograph.
- History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
- History of diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS].
- Receiving immunomodulatory or immunosuppressive therapy.
- Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
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- Immunocompromised at the time of enrollment.
- Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
- Inability to comply with study requirements.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Clinique Neuro-Outaouais
Gatineau, Quebec, J9J 0A5
Neuro Rive-Sud
Greenfield Park, Quebec, J4V 2J2
Dalhousie MS Research Unit
Halifax, Nova Scotia, B3H 4K4
London Health Sciences Centre
London, Ontario, N6A 5A5
CHUM - Hopital Notre Dame
Montreal, Quebec, H2L 4M1
McGill University - MNI
Montreal, Quebec, H3A 2B4
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Cape Breton Regional Hospital
Sydney, Nova Scotia, B1P 1P3
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
About this study
Official title: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients
The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
Measured: Baseline, Months 12 and 24
Secondary outcomes (6)
Change from Baseline in Annualized Relapse Rate
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.
Measured: Baseline, Months 12 and 24
Change from Baseline in Expanded Disability Status Scale (EDSS)
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Measured: Baseline, Months 12 and 24
Change from Baseline in Work Productivity and Activity Impairment
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Baseline, Months 12 and 24
Change from Baseline in EuroQol 5-Dimension (EQ-5D)
The EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), and a visual analog scale that records the respondent's self-rated health from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline, Months 12 and 24
Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale
Patient Global Assessment of Wellbeing measures quality of life on a 100 mm Visual Analog Scale (VAS) where 0 is the worst imaginable health state and 100 is the best imaginable health state.
Measured: Baseline, Months 12 and 24
Percentage of participants with Clinical Disease-Free Status
Freedom from clinical disease activity is defined as the percentage of participants with no relapse and no EDSS progression, defined as a 1-point change from baseline. EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Measured: Baseline, Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start7 Nov 2012
- Primary completion2 Oct 2015
- Study completion2 Oct 2015
Why it stopped: Due to on-going enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706107
- Sponsor's protocol ID
- CAN-TYS-12-10333
- Acronym
- COSTAN
- Status last verified
- May 2024
- First submitted
- 11 Oct 2012
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01706107
- Acronym / sponsor ID
- COSTAN / CAN-TYS-12-10333
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to on-going enrollment challenges
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2012 (actual)
- Primary completion
- 2 Oct 2015 (actual)
- Study completion
- 2 Oct 2015 (actual)
- First posted
- 15 Oct 2012 (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 primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who choose to participate in the study will receive a thorough description of the study protocol and an informed consent document describing the study and the risks and benefits of participating. Recruitment will continue until approximately 150 patients have been enrolled in the study at approximately 15 sites across Canada.
Key inclusion criteria (6 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
- Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
- Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
- Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
Key exclusion criteria (11 listed)
- Any prior treatment with Tysabri.
- Contraindications to treatment with Tysabri as described in the Product Monograph.
- History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
- History of diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS].
- Receiving immunomodulatory or immunosuppressive therapy.
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
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: Baseline, Months 12 and 24
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
6 secondary outcomes
Change from Baseline in Annualized Relapse Rate
Time frame: Baseline, Months 12 and 24
Change from Baseline in Expanded Disability Status Scale (EDSS)
Time frame: Baseline, Months 12 and 24
Change from Baseline in Work Productivity and Activity Impairment
Time frame: Baseline, Months 12 and 24
Change from Baseline in EuroQol 5-Dimension (EQ-5D)
Time frame: Baseline, Months 12 and 24
Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale
Time frame: Baseline, Months 12 and 24
Percentage of participants with Clinical Disease-Free Status
Time frame: Baseline, Months 12 and 24
Results and safety
The study was stopped early (reason given: Due to on-going enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
Medical Director study director
Biogen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 11 sites 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 was stopped early (reason given: Due to on-going enrollment challenges). Results are not available in the source record.
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?
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) (time frame: Baseline, Months 12 and 24). 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 3 Jun 2024.