- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00288990
A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis
Impact of Neutralizing Antibodies on Interferon Responsive Genes Highlights Biomarker Response.
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 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)
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:
- 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.
- 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)
- 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.
- To correlate NAb titer levels with b-IFN induced biomarker response (data taken from baseline and month 6 visits from Group 1).
- 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:
- Patients (male or female) diagnosed with relapsing forms of MS.
- Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive.
- All levels of disability
- Age 18-65 years inclusive
- 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.
- Patients with prior b-IFN NAb test (whether positive or negative).
- 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).
- 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.
- 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)
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama - Birmingham
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Cullman, Alabama, 미국, 35058
- Physicians Resource Network
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Arizona
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Phoenix, Arizona, 미국, 85013
- Barrow Neurological Institute
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California
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Irvine, California, 미국, 92697
- University of California - Irvine
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San Francisco, California, 미국, 94117
- University of California San Francisco - MS Center
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Florida
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Tampa, Florida, 미국, 33609
- Tampa Neurology
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Peoria, Illinois, 미국, 61637
- OSF Saint Francis Medical Center, Illinois Neurological Institute
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Indiana
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Fort Wayne, Indiana, 미국, 46805
- Fort Wayne Neurological Center
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Iowa
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Des Moines, Iowa, 미국, 50314
- Mercy Ruan Neurology Clinic
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Kentucky
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Louisville, Kentucky, 미국, 40202
- Kentucky Neuroscience Research / University Neurologists, P.S.C
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Louisiana
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Shreveport, Louisiana, 미국, 71130
- Louisiana State University Health Sciences Center
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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Missouri
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St. Louis, Missouri, 미국, 63110
- Washington University
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St. Louis, Missouri, 미국, 63110
- BJC Medical Group
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New York
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White Plains, New York, 미국, 10601
- Family Health Center
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Ohio
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Columbus, Ohio, 미국, 43221
- The Multiple Sclerosis Center at the Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02905
- Brown University / Rhode Island Hospital
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Tennessee
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Knoxville, Tennessee, 미국, 37922
- The Baptist Hospital of East Tennessee
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Nashville, Tennessee, 미국, 37212
- Vanderbilt University
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Nashville, Tennessee, 미국, 37205
- The Advanced Neurosciences Institute
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine - The Methodist College Multiple Sclerosis Center
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Houston, Texas, 미국, 77030
- The University of Texas Houston
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Virginia
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Fairfax, Virginia, 미국, 22031
- Neurology Center of Fairfax, Ltd.
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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Tacoma, Washington, 미국, 95405
- Neurology Associates of Tacoma
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients (male or female) diagnosed with relapsing forms of MS.
- Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive.
- All levels of disability
- Age 18-65 years inclusive
- Subjects must be willing to be followed for the 6-month study period.
Exclusion Criteria:
- Patients with prior b-IFN NAb test (whether positive or negative).
- 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).
- 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.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
1
subjects who are NAb positive
|
2
Subjects who are antibody negative
|
3
subjects who are BAb positive
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Thorsten Eickenhorst, MD, Biogen
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 008-05-AVX
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다발성 경화증에 대한 임상 시험
-
University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스