DrugLib.com — Drug Information Portal

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



A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Thorsten Eickenhorst, MD, Study Director, Affiliation: Biogen

Summary

Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker Response in Patients with Multiple Sclerosis Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups: Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer 20NU/ml) Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20 NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer 8U) and NAb- (titer <20 NU/ml) The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients. Secondary objectives are: 1. To compare b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients at the month 6 visit. 2. To compare b-IFN induced biomarker response (viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers < 20NU/ml, BAb-, titers <8U, Group 2) patients (data compared at baseline and month 6 visits) 3. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. BAb+ (titers ³8U)/NAb- (titers <20 NU/ml, Group 3) patients at baseline and month 6 visits. 4. To correlate NAb titer levels with b-IFN induced biomarker response (data taken from baseline and month 6 visits from Group 1). 5. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in BAb-/NAb- patients (Group 2) vs. BAb +/NAb- patients (Group 3) in order to determine if BAbs affect b-IFN induced biomarker response (data compared at baseline and month 6 visits). Tertiary objectives are: 1. To explore patient characteristics that may predict NAb positivity. Design: This is a multi-center, open-label study of approximately 300 (200 NAb+ and 100 NAb- (50 BAb+ and 50 BAb-)) MS patients that will compare b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive vs. antibody negative patients. Study Population: Approximately 300 subjects (200 in Group 1, 50 in Group 2, and 50 in Group 3) will be recruited for the study. Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of randomization: 1. Patients (male or female) diagnosed with relapsing forms of MS. 2. Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive. 3. All levels of disability 4. Age 18-65 years inclusive 5. Subjects must be willing to be followed for the 6-month study period. Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of study initiation. 1. Patients with prior b-IFN NAb test (whether positive or negative). 2. Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy (b-IFN plus any other immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a relapse). 3. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol. 4. Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study. Treatment Groups: This is a multi-center, open-label study of approximately 300 (200 NAb+ patients and 100 NAb- patients (50 BAb+ and 50 BAb-)) relapsing MS patients that will compare b-IFN induced biomarker response following b-IFN injection in neutralizing antibody positive vs. antibody negative patients. Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups: Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml) Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer <8U) and NAb- (titer <20 NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer <20 NU/ml)

Clinical Details

Official title: Impact of Neutralizing Antibodies on Interferon Responsive Genes Highlights Biomarker Response.

Study design: Observational Model: Case Control, Time Perspective: Prospective

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients (male or female) diagnosed with relapsing forms of MS. 2. Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive. 3. All levels of disability 4. Age 18-65 years inclusive 5. Subjects must be willing to be followed for the 6-month study period. Exclusion Criteria: 1. Patients with prior b-IFN NAb test (whether positive or negative). 2. Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy (b-IFN plus any other immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a relapse). 3. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol. 4. Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study.

Locations and Contacts

University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

Physicians Resource Network, Cullman, Alabama 35058, United States

Barrow Neurological Institute, Phoenix, Arizona 85013, United States

University of California - Irvine, Irvine, California 92697, United States

University of California San Francisco - MS Center, San Francisco, California 94117, United States

Tampa Neurology, Tampa, Florida 33609, United States

Northwestern University, Chicago, Illinois 60611, United States

University of Chicago, Chicago, Illinois 60637, United States

OSF Saint Francis Medical Center, Illinois Neurological Institute, Peoria, Illinois 61637, United States

Fort Wayne Neurological Center, Fort Wayne, Indiana 46805, United States

Mercy Ruan Neurology Clinic, Des Moines, Iowa 50314, United States

Kentucky Neuroscience Research / University Neurologists, P.S.C, Louisville, Kentucky 40202, United States

Louisiana State University Health Sciences Center, Shreveport, Louisiana 71130, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

BJC Medical Group, St. Louis, Missouri 63110, United States

Washington University, St. Louis, Missouri 63110, United States

Family Health Center, White Plains, New York 10601, United States

The Multiple Sclerosis Center at the Ohio State University, Columbus, Ohio 43221, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Brown University / Rhode Island Hospital, Providence, Rhode Island 02905, United States

The Baptist Hospital of East Tennessee, Knoxville, Tennessee 37922, United States

The Advanced Neurosciences Institute, Nashville, Tennessee 37205, United States

Vanderbilt University, Nashville, Tennessee 37212, United States

Baylor College of Medicine - The Methodist College Multiple Sclerosis Center, Houston, Texas 77030, United States

The University of Texas Houston, Houston, Texas 77030, United States

Neurology Center of Fairfax, Ltd., Fairfax, Virginia 22031, United States

University of Washington, Seattle, Washington 98195, United States

Neurology Associates of Tacoma, Tacoma, Washington 95405, United States

Additional Information

Starting date: January 2006
Last updated: December 20, 2007

Page last updated: August 20, 2015

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

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