Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis
Phase: N/A
Status: Active, not recruiting
Sponsored by: Biogen Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Biogen
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])
Clinical Details
Official title: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Proportion of Participants who are overall disease activity-free at Months 12 and 24Proportion of participants who are clinical disease activity-free at Months 36 and 48
Secondary outcome: Identification of baseline prognostic factors that predict overall disease-free statusIdentification of yearly overall disease-free response factors that predict overall disease-free status Clinical disease-free status Identification of baseline prognostic factors that predict clinical disease-free status Identification of yearly clinical disease-free response factors that predict clinical disease-free status Annualized Relapse Rate Percentage of participants with Sustained EDSS progression Sustained EDSS improvement Change form baseline in number of new or newly enlarging T2 hyperintense lesions as assessed by MRI Change from baseline in number of new T1 hypointense lesions as assessed by MRI Change form baseline in number of T1 lesions with Gd-enhancing lesions as assessed by MRI MRI brain atrophy as assessed by MRI Change from baseline in retinal nerve fiber layer (RNFL) thickness as assessed by OCT Change from baseline in low contrast visual acuity Change from baseline in high contrast visual acuity Cognitive impairment as assessed by change from baseline in SDMT Capacity for work as assessed by change from baseline in WPAI questionnaire Quality of Life as measured by MSIS-29
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Key Inclusion Criteria:
- 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-naïve 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.
Key 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 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations and Contacts
Research Site, Homewood, Alabama 35209, United States
Research Site, Berkeley, California 94705, United States
Research Site, La Jolla, California 92037, United States
Research Site, Los Angeles, California 90089, United States
Research Site, Aurora, Colorado 80045, United States
Research Site, Ft. Collins, Colorado 80528, United States
Research Site, Newark, Delaware 19713, United States
Research Site, Washington, District of Columbia 20007, United States
Research Site, Gainesville, Florida 32610, 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 61637, 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, Boston, Massachusetts 02135, United States
Research Site, Lexington, Massachusetts 02421, 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 10021, United States
Research Site, New York, New York 10016, 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, Cleveland, Ohio 44195, United States
Research Site, Dayton, Ohio 45417, 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
Additional Information
Starting date: January 2012
Last updated: July 10, 2015
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