Clinical trial NCT01706107: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Official title: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Quality of life
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: Baseline, Months 12 and 24
Secondary outcomes:
measure: Change from Baseline in Annualized Relapse Rate
timeFrame: Baseline, Months 12 and 24
measure: Change from Baseline in Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, Months 12 and 24
measure: Change from Baseline in Work Productivity and Activity Impairment
timeFrame: Baseline, Months 12 and 24
measure: Change from Baseline in EuroQol 5-Dimension (EQ-5D)
timeFrame: Baseline, Months 12 and 24
measure: Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale
timeFrame: Baseline, Months 12 and 24
measure: Percentage of participants with Clinical Disease-Free Status
timeFrame: Baseline, Months 12 and 24
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Dalhousie MS Research Unit
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Regional Hospital
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: Neuro Rive-Sud
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University - MNI
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont
state: Quebec
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: