Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
STRIVE
A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
1 other identifier
observational
231
1 country
44
Brief Summary
The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale \[EDSS\]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test \[SDMT\]), capacity for work (Work Productivity and Activity Impairment Questionnaire \[WPAI\]), quality of life (QoL) (Multiple Sclerosis Impact Scale \[MSIS-29\])
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 5, 2011
CompletedStudy Start
First participant enrolled
February 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2018
CompletedFebruary 12, 2019
February 1, 2019
6.8 years
December 1, 2011
February 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of Participants who are overall disease activity-free at Months 12 and 24
Overall disease activity-free is defined as no relapses, no disability progression (RRMS), and absence of MRI disease activity (no gadolinium \[gd\])+ lesions, no new or enlarging T2-hyperintense lesions). A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Sustained disability progression defined by at least a 1.0-point increase on the EDSS from a Baseline EDSS ≥1.0 that is sustained for 12 or 24 weeks, or at least a 1.5-point increase on the EDSS from a Baseline EDSS \<1.0 that is sustained for 12 or 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
Baseline and Months 12 and 24
Proportion of participants who are clinical disease activity-free at Months 36 and 48
Clinical disease activity-free is defined as no sustained EDSS progression and no relapses at Month 36 and 48.
Baseline and Months 36 and 48
Secondary Outcomes (19)
Identification of baseline prognostic factors that predict overall disease-free status
Baseline and Month 12
Identification of yearly overall disease-free response factors that predict overall disease-free status
Month 12 and Month 24
Number of Participants with Clinical Disease-Free Status Measured by Relapses
Months 12, 24, 36, and 48
Identification of baseline prognostic factors that predict clinical disease-free status
Month 12
Identification of yearly clinical disease-free response factors that predict clinical disease-free status
Months 24, 36 and 48
- +14 more secondary outcomes
Interventions
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
Eligibility Criteria
Study participants will be recruited by participating neurologists from among their MS patients who opt to begin treatment with Tysabri.
You may qualify if:
- Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria ).
- \<3 year disease duration.
- Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
- Anti-JCV antibody negative test within 6 months of Screening Visit.
- Must satisfy the approved therapeutic indications for Tysabri.
- Must be treatment-naĂ¯ve to disease-modifying therapy (DMT) or have been treated with DMT (including but not limited to Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤36 months 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.
- 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 progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
- History of diagnosis of Primary Progressive Multiple Sclerosis (PPM) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (44)
Research Site
Homewood, Alabama, 35209, United States
Research Site
Sun City, Arizona, 85351, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Los Angeles, California, 90032, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Fort Collins, Colorado, 80528, United States
Research Site
Newark, Delaware, 19713, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Jacksonville, Florida, 32209, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Lake Barrington, Illinois, 60010, United States
Research Site
Peoria, Illinois, 61603, United States
Research Site
Indianapolis, Indiana, 46256, United States
Research Site
Indianapolis, Indiana, 46260, United States
Research Site
Overland Park, Kansas, 66212, United States
Research Site
Louisville, Kentucky, 40207, United States
Research Site
New Orleans, Louisiana, 70121, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Lexington, Massachusetts, 02421, United States
Research Site
Wellesley Hills, Massachusetts, 02481, United States
Research Site
Worcester, Massachusetts, 01655, United States
Research Site
East Lansing, Michigan, 48824, United States
Research Site
Lincoln, Nebraska, 68521, United States
Research Site
Freehold, New Jersey, 07728, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10021, United States
Research Site
Patchogue, New York, 11772, United States
Research Site
Plainview, New York, 11803, United States
Research Site
Staten Island, New York, 10306, United States
Research Site
Stony Brook, New York, 11794, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Gahanna, Ohio, 43230, United States
Research Site
Uniontown, Ohio, 44685, United States
Research Site
Portland, Oregon, 97225, United States
Research Site
Dallas, Texas, 75235, United States
Research Site
Round Rock, Texas, 78681, United States
Research Site
Salt Lake City, Utah, 84103, United States
Research Site
Newport News, Virginia, 23601, United States
Research Site
Norfolk, Virginia, 23502, United States
Research Site
Seattle, Washington, 98101, United States
Research Site
Tacoma, Washington, 98405, United States
Related Publications (5)
Perumal J, Balabanov R, Balcer L, Galetta S, Sun Z, Li H, Rutledge D, Avila RL, Fox RJ. Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE Data Analysis. Neurol Ther. 2023 Jun;12(3):833-848. doi: 10.1007/s40120-023-00461-0. Epub 2023 Mar 26.
PMID: 36966440DERIVEDPerumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Correction to: Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2023 Mar;37(3):275-289. doi: 10.1007/s40263-022-00982-6.
PMID: 36780107DERIVEDPerumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2022 Sep;36(9):977-993. doi: 10.1007/s40263-022-00950-0. Epub 2022 Sep 5.
PMID: 36064841DERIVEDPerumal J, Balabanov R, Su R, Chang R, Balcer L, Galetta S, Campagnolo DI, Avila R, Lee L, Rutledge D, Fox RJ. Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study. Adv Ther. 2021 Jul;38(7):3724-3742. doi: 10.1007/s12325-021-01722-w. Epub 2021 May 20.
PMID: 34014549DERIVEDPerumal J, Fox RJ, Balabanov R, Balcer LJ, Galetta S, Makh S, Santra S, Hotermans C, Lee L. Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE. BMC Neurol. 2019 Jun 8;19(1):116. doi: 10.1186/s12883-019-1337-z.
PMID: 31176355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 5, 2011
Study Start
February 7, 2012
Primary Completion
November 26, 2018
Study Completion
November 26, 2018
Last Updated
February 12, 2019
Record last verified: 2019-02