Trial record 1 of 1 for:    strive anti-jcv
Previous Study | Return to List | Next Study

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Biogen Idec.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01485003
First received: December 1, 2011
Last updated: September 12, 2013
Last verified: August 2012

December 1, 2011
September 12, 2013
Not Provided
Not Provided
  • Proportion of patients who are overall disease activity-free [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Proportion of patients who are clinical disease activity-free [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01485003 on ClinicalTrials.gov Archive Site
  • Identification of baseline prognostic factors that predict overall disease-free status [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Identification of yearly prognostic factors that predict overall disease-free status [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Clinical disease-free status [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Identification of baseline prognostic factors that predict clinical disease-free status [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Identification of yearly prognostic factors that predict clinical disease-free status [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Sustained EDSS progression [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Sustained EDSS improvement [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T2 measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T1 measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T1 with Gadolinium-enhancing measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI brain atrophy measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Low Contrast Visual Acuity assessment [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Cognitive impairment as measured with the Symbol Digit Modalities Test (SDMT) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Capacity for work as measured by the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Quality of Life as measured by the Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Identification of baseline prognostic factors that predict overall disease-free status [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Identification of yearly prognostic factors that predict overall disease-free status [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Clinical disease-free status [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Identification of baseline prognostic factors that predict clinical disease-free status [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Identification of yearly prognostic factors that predict clinical disease-free status [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Sustained EDSS progression [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Sustained EDSS improvement [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T2 measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T1 measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI T1 with Gadolinium-enhancing measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • MRI brain atrophy measure [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Low Contrast Visual Acuity assessment [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Cognitive impairment as measured with the Symbol Digit Modalities Test (SDMT) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Capacity for work as measured by the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Quality of Life as measured by the Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing -Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients.

The purpose of the study is to find out if there are any assessments that might predict whether or not patients receiving Tysabri will remain free of disease (that is, without relapses, worsened disability, and/or lesions on brain magnetic imaging [MRI] scans) and how effective Tysabri is at keeping patients who are in the early stages of RRMS free of disease.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with relapsing-remitting multiple sclerosis (RRMS) presenting to sponsor selected neurology offices in the US who meet inclusion & exclusion criteria.

Relapsing-remitting Multiple Sclerosis
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
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
  • Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria [Polman et al., 2011]).
  • <3 year disease duration.
  • Must have an EDSS score from 0 to 4.0, inclusive.
  • Anti-JCV antibody negative test at Screening Visit
  • Must satisfy the approved therapeutic indications for Tysabri.
  • Must be treatment-naïve to disease-modifying therapy (DMT) or have been treated with a single DMT (including Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤12 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 prior to the Screening Visit.
  • Contraindications to treatment with Tysabri as described in the US Prescribing Information.
  • 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 45 Years
Not Provided
Contact: Medical Director strivestudy@biogenidec.com
United States
 
NCT01485003
101MS407
Not Provided
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
August 2012

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