Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (COSTAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01706107
First received: October 11, 2012
Last updated: February 19, 2015
Last verified: February 2015

October 11, 2012
February 19, 2015
April 2012
October 2017   (final data collection date for primary outcome measure)
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
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.
Multiple Sclerosis Impact Scale-29 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01706107 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Annualized Relapse Rate [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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.
  • Change from Baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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.
  • Change from Baseline in Work Productivity and Activity Impairment [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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.
  • Change from Baseline in EuroQol 5-Dimension (EQ-5D) [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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).
  • Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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.
  • Percentage of participants with Clinical Disease-Free Status [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    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.
  • Annualized Relapse Rate at each analysis timepoint and change from Baseline [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS) change over time [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment at each analysis timepoint and change from Baseline [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • EuroQol 5-Dimension at each analysis timepoint and change from Baseline [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Wellbeing Visual Analog Scale at each analysis timepoint and change from Baseline [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Clinical Disease-Free Status (relapses, EDSS) at each analysis timepoint [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Relapsing-Remitting Multiple Sclerosis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2018
October 2017   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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).
  • 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.

Both
18 Years to 65 Years
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
Canada
 
NCT01706107
CAN-TYS-12-10333
No
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP