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

October 11, 2012
September 12, 2013
April 2012
October 2015   (final data collection date for primary outcome measure)
Multiple Sclerosis Impact Scale-29 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01706107 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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. 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

Multiple Sclerosis, Relapsing-Remitting
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2016
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Vladimir Migounov vladimir.migounov@biogenidec.com
Canada
 
NCT01706107
CAN-TYS-12-10333
No
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
November 2012

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