DrugLib.com — Drug Information Portal

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



Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: natalizumab (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Overall contact:
Biogen, Email: clinicaltrials@biogen.com

Summary

The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the proportion of participants with no evidence of disease activity (NEDA) at Year 1. The secondary objectives in this study population are: Change in total T1 hypointense and total T2 hyperintense lesion volume; Proportion of participants with NEDA at Year 2; Evaluation of the impact of natalizumab on annualized relapse rate (ARR); and Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical impact score.

Clinical Details

Official title: A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenyaź to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The proportion of participants who have NEDA as measured by the number of participants that do not experience Expanded Disability Status Scale (EDSS) progression for a sustained period of 12 weeks.

The proportion of participants who have NEDA as measured by the number of participants that do not experience a relapse

The proportion of participants who have NEDA as measured by the number of participants that do not experience gadolinium enhancing (Gd+) positive lesions

The proportion of participants who have NEDA as measured by the number of participants that do not experience new T2 hyperintense lesions.

The proportion of participants who have NEDA as measured by the number of participants that do not experience new or enlarging T2 hyperintense lesions.

Secondary outcome:

Change in total T1 hypointense and total T2 hyperintense lesion volume

Change in total T1 hypointense and total T2 hyperintense lesion volume from Reset baseline (week 8) to week 56

The proportion of participants who have NEDA as measured by the number of participants that do not experience EDSS progression for a sustained period of 12 weeks.

The proportion of participants who have NEDA as measured by the number of participants that do not experience a relapse

The proportion of participants who have NEDA as measured by the number of participants that do not experience Gd+ positive lesions

The proportion of participants who have NEDA as measured by the number of participants that do not experience new T2 hyperintense lesions.

The proportion of participants who have NEDA as measured by the number of participants that do not experience newly enlarging T2 hyperintense lesions.

Annualized Relapse Rate

Change in MSIS-29 physical impact

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Subjects of childbearing potential must practice effective contraception from Day -1

and be willing and able to continue contraception for duration of the study.

- Must have documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011])

at Screening.

- Must have been treated with Gilenya or BRACET for at least the 6 months prior to

Screening with no interruption of treatment. Prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the Screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.

- Must have had disease activity in the 12 months prior to Screening while on Gilenya

or BRACET (as defined by at least 1 Gd+ lesion OR at least 2 new T2 lesions (compared with an MRI done within 12 months of screening) OR clinical relapse, or EDSS progression of 1 point)

- Must have an EDSS score from 0 to 5. 5 inclusive at Screening.

- Must have lymphocyte count that is documented as at or above the lower limit of

normal (LLN) by the day before the first Tysabri infusion. If lymphocytes have not returned to LLN or above the day before the first Tysabri infusion (day 0), the subject has screen failed. The subject who screen fails is eligible to undergo Rescreening once; if additional Rescreening is considered, please contact the study medical monitor. Key Exclusion Criteria:

- History or positive test result at Screening for human immunodeficiency virus (HIV).

- History or positive test result at Screening for hepatitis C virus antibody (HCV Ab)

or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis core antibody [HBcAb]).

- Prior treatment with natalizumab (either commercially or through a clinical study)

within 1 year of Day - 1.

- Contraindications to treatment with natalizumab as described in the Prescribing

Information for each of the participating countries.

- Known allergy to natalizumab or any of its ingredients, or known to be

anti-natalizumab antibody positive.

- Diagnosis of primary progressive MS, secondary progressive MS, and/or

progressive-relapsing MS.

- An MS relapse that has occurred within the 30 days prior to Day -1 and/or the subject

has not stabilized from a previous relapse prior to Day - 1.

- Known active malignancies (subjects with cutaneous basal cell carcinoma that has been

completely excised prior to study entry remain eligible).

- History of severe opportunistic infections (including PML) or any clinically

significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator

- Clinically severe active infection within 1 month prior to Screening.

- Females breastfeeding, pregnant, or planning to become pregnant; women who are not

post-menopausal or surgically sterile who are unwilling to practice contraception;

women who have a positive pregnancy test result at Day - 1.

- Prior history of immunosuppressant use (e. g., mitoxantrone, azathioprine,

methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to Screening. Prior history of alemtuzumab use at any point in the past. NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Biogen, Email: clinicaltrials@biogen.com

Research Site, Cullman, Alabama 35058, United States; Recruiting

Research Site, Tuebingen, Baden Wuerttemberg 72076, Germany; Not yet recruiting

Research Site, Fullerton, California 92835, United States; Recruiting

Research Site, Aurora, Colorado 80045, United States; Recruiting

Research Site, Fort Collins, Colorado 80528, United States; Recruiting

Research Site, Atlanta, Georgia 30327, United States; Recruiting

Research Site, Chicago, Illinois 60637, United States; Not yet recruiting

Research Site, Peoria, Illinois 61606, United States; Recruiting

Research Site, Des Moines, Iowa 50314, United States; Recruiting

Research Site, Kansas City, Kansas 66160, United States; Not yet recruiting

Research Site, Boston, Massachusetts 02114, United States; Not yet recruiting

Research Site, St. Louis, Missouri 63110, United States; Recruiting

Research Site, Buffalo, New York 14203, United States; Not yet recruiting

Research Site, Plainview, New York 11803, United States; Recruiting

Research Site, Stony Brook, New York 11794, United States; Not yet recruiting

Research Site, Muenster, Nordrhein Westfalen 48149, Germany; Not yet recruiting

Research Site, Raleigh, North Carolina 27607-6010, United States; Recruiting

Research Site, Akron, Ohio 44320, United States; Recruiting

Research Site, Cleveland, Ohio 44195, United States; Recruiting

Research Site, Dresden, Sachsen 1307, Germany; Not yet recruiting

Research Site, Knoxville, Tennessee 37922, United States; Recruiting

Research Site, Nashville, Tennessee 37232-8805, United States; Not yet recruiting

Research Site, Round Rock, Texas 78681, United States; Recruiting

Research Site, Charlottesville, Virginia 22908, United States; Recruiting

Research Site, Seattle, Washington 98122-4470, United States; Recruiting

Research Site, Tacoma, Washington 98405, United States; Recruiting

Research Site, Franklin, Wisconsin 53132, United States; Recruiting

Additional Information

Starting date: September 2014
Last updated: August 20, 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