Trial record 10 of 314 for:    "Multiple Sclerosis, Relapsing-Remitting"

Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients (COSTAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01706107
First received: October 11, 2012
Last updated: September 12, 2013
Last verified: November 2012
  Purpose

Multicenter, observational, longitudinal. The primary objective of the study is to evaluate the impact of early RRMS treatment with Tysabri in anti-JCV antibody negative patients on their quality of life (QoL) measured by MSIS-29 over 2 years.

The secondary objectives of the study are:

  • To evaluate the impact of early RRMS treatment with Tysabri in anti-JCV antibody negative patients over 2 years on the following:

    • annualized relapse rate (ARR)
    • EDSS
    • work productivity
    • QoL by EQ-5D
    • QoL by Subject Global Assessment of Wellbeing VAS
  • To evaluate clinical disease-free status (relapses, EDSS) over 2 years The tertiary objective of the study is to evaluate correlations between the endpoints.

Number of Subjects: 150 Study Population: Anti-JCV antibody negative RRMS patients who either are treatment-naïve with a highly active disease (≥ 2 relapses in the year prior to study entry and ≥ 1 Gd+ lesion on T1-weighted MRI at study entry) or have failed an adequate course of their first-line disease modifying therapy (DMT), and who have been prescribed Tysabri as per the labeling.

Treatment Groups: Single arm. Interim Analysis: An interim analysis will be performed at month 12 of observation.

Visit Schedule: As per routine clinical practice. Efficacy Parameters: Passive collection of ARR and EDSS at the scheduled visits.

Safety Parameters: As per routine pharmacovigilance.


Condition
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Multiple Sclerosis Impact Scale-29 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Multicenter, observational, longitudinal. The primary objective of the study is to evaluate the impact of early RRMS treatment with Tysabri in anti-JCV antibody negative patients on their quality of life (QoL) measured by MSIS-29 over 2 years.

The secondary objectives of the study are:

  • To evaluate the impact of early RRMS treatment with Tysabri in anti-JCV antibody negative patients over 2 years on the following:

    • annualized relapse rate (ARR)
    • EDSS
    • work productivity
    • QoL by EQ-5D
    • QoL by Subject Global Assessment of Wellbeing VAS
  • To evaluate clinical disease-free status (relapses, EDSS) over 2 years The tertiary objective of the study is to evaluate correlations between the endpoints.

Number of Subjects: 150 Study Population: Anti-JCV antibody negative RRMS patients who either are treatment-naïve with a highly active disease (≥ 2 relapses in the year prior to study entry and ≥ 1 Gd+ lesion on T1-weighted MRI at study entry) or have failed an adequate course of their first-line disease modifying therapy (DMT), and who have been prescribed Tysabri as per the labeling.

Treatment Groups: Single arm. Interim Analysis: An interim analysis will be performed at month 12 of observation.

Visit Schedule: As per routine clinical practice. Efficacy Parameters: Passive collection of ARR and EDSS at the scheduled visits.

Safety Parameters: As per routine pharmacovigilance.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. Patients who withdraw and complete the exit interview will not be eligible to re-enroll in the study. The subject will be considered to be enrolled in the study once this identification number has been generated. Patients who convert to anti-JCV antibody positive status during the course of the study will be allowed to continue on Tysabri and in the study at the discretion of the participating neurologi

Criteria

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
  • Age 18 to 65 years old, inclusive, at time of informed consent.
  • Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria [Polman et al., 2011]).
  • Must have an EDSS score from 0 to 3.5, inclusive.
  • Anti-JCV antibody negative test within 3 months of Screening Visit or negative test for anti-JCV antibody at Baseline Visit.
  • Must satisfy the approved therapeutic indications for Tysabri and the existing reimbursement criteria as either 1st line (highly active) or 2nd line therapy in respective provinces.
  • Must either be treatment naïve with highly active disease (≥ 2 relapses in the year prior to study entry and ≥ 1 Gd+ lesion on T1-weighted MRI at study entry) or have been treated with a single DMT (including Avonex, Betaseron, Rebif, Copaxone, or Extavia) for ≥12 months and ≤18 months total prior to date of informed consent.
  • Decision to treat with Tysabri must precede enrollment.

Exclusion Criteria:

  • Any prior treatment with Tysabri.
  • Anti-JCV antibody positive at any timepoint.
  • Contraindications to treatment with Tysabri as described in the Product Monograph.
  • History of 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706107

Contacts
Contact: Vladimir Migounov vladimir.migounov@biogenidec.com

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Vancouver Island Health Authority Not yet recruiting
Victoria, British Columbia, Canada, V8R 1J8
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Dalhousie MS Research Unit Recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Cape Breton Regional Hospital Not yet recruiting
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
South Muskoka Medical Clinic Recruiting
Bracebridge, Ontario, Canada, P1L 2E1
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique Neuro-Outaouais Not yet recruiting
Gatineau, Quebec, Canada, J9J 0A5
Neuro Rive-Sud Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
CHUM - Hopital Notre Dame Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
McGill University - MNI Recruiting
Montreal, Quebec, Canada, H3A 2B4
Hopital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
CHUS - Hopital Fleurimont Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01706107     History of Changes
Other Study ID Numbers: CAN-TYS-12-10333
Study First Received: October 11, 2012
Last Updated: September 12, 2013
Health Authority: Canada: Health Canada

Keywords provided by Biogen Idec:
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014