DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 24

Proportion 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 status

Identification 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017