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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Phase: N/A

Status: Recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Overall contact:
Biogen, Email: clinicaltrials@biogen.com

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.

Clinical Details

Official title: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)

Secondary outcome:

Change from Baseline in Annualized Relapse Rate

Change from Baseline in Expanded Disability Status Scale (EDSS)

Change from Baseline in Work Productivity and Activity Impairment

Change from Baseline in EuroQol 5-Dimension (EQ-5D)

Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale

Percentage of participants with Clinical Disease-Free Status

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Biogen, Email: clinicaltrials@biogen.com

Vancouver Island Health Authority, Victoria, British Columbia V8R 1J8, Canada; Recruiting

Saint John Regional Hospital, Saint John, New Brunswick E2L 4L2, Canada; Recruiting

Dalhousie MS Research Unit, Halifax, Nova Scotia B3H 4K4, Canada; Recruiting

Cape Breton Regional Hospital, Sydney, Nova Scotia B1P 1P3, Canada; Recruiting

London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting

The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada; Completed

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting

Clinique Neuro-Outaouais, Gatineau, Quebec J9J 0A5, Canada; Recruiting

Neuro Rive-Sud, Greenfield Park, Quebec J4V 2J2, Canada; Recruiting

CHUM - Hopital Notre Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting

Hopital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada; Recruiting

McGill University - MNI, Montreal, Quebec H3A 2B4, Canada; Recruiting

CHUS - Hopital Fleurimont, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting

Additional Information

Starting date: April 2012
Last updated: July 23, 2015

Page last updated: August 23, 2015

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