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

NCT01706107 | Terminated

• 1 other identifier: CAN-TYS-12-10333
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 11

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Months 12 and 24

Secondary Outcomes (6)

• Change from Baseline in Annualized Relapse Rate

  Baseline, Months 12 and 24

• Change from Baseline in Expanded Disability Status Scale (EDSS)

  Baseline, Months 12 and 24

• Change from Baseline in Work Productivity and Activity Impairment

  Baseline, Months 12 and 24

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

  Baseline, Months 12 and 24

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

  Baseline, Months 12 and 24

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (11)

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dalhousie MS Research Unit

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Cape Breton Regional Hospital

Sydney, Nova Scotia, B1P 1P3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

Location

Neuro Rive-Sud

Greenfield Park, Quebec, J4V 2J2, Canada

Location

CHUM - Hopital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - MNI

Montreal, Quebec, H3A 2B4, Canada

Location

CHUS - Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: November 7, 2012
• Primary Completion: October 2, 2015
• Study Completion: October 2, 2015
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

CA (11)