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

This study is currently recruiting participants.
Verified December 2012 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01485003
First received: December 1, 2011
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Relapsing-remitting Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing -Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485003

Contacts
Contact: Medical Director strivestudy@biogenidec.com

  Show 64 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01485003     History of Changes
Other Study ID Numbers: 101MS407
Study First Received: December 1, 2011
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

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 May 23, 2013