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Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rebif®
Copaxone®
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be between 18 and 60 years of age Have definite relapsing multiple sclerosis Have had one or more relapses within the prior 12 months Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1 Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized Be willing and able to comply with the protocol for the duration of the study Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care Exclusion Criteria: Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS) Prior use of any interferon or glatiramer acetate Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI) Have a psychiatric disorder that is unstable or would preclude safe participation in the study. Have significant leukopenia (white blood cell count < 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1. Have elevated liver function tests (alanine aminotransferase [AST], aspartate aminotransferase [ALT], alkaline phosphatase > 2.0 times the upper limit of normal [ULN] of the central laboratory, or total bilirubin > 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced) Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1 Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1 Prior use of cladribine or have received total lymphoid irradiation Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1. Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus [HIV], human T-cell lymphotrophic virus type I [HTLV-1]) Have had plasma exchange in 3 months prior to Study Day 1.

Sites / Locations

  • University of Alabama at Birmingham
  • Barrow Neurology Clinics
  • Northwest NeuroSpecialists
  • University of California, Davis
  • Kaiser Permanente Neurology
  • Advanced Neurology of Colorado, LLC
  • The MS Treatment Center at Griffin Hospital
  • Associated Neurologists of Southern Connecticut, P.C.
  • Neurological Center of South Florida
  • Harbourside Medical Plaza
  • Shepherd Center
  • University Chicago Hospitals
  • Consultants In Neurology, Ltd.
  • Fort Wayne Neurological Center
  • University of Maryland MD Center for MS
  • University Of Michigan
  • Wayne State University
  • Henry Ford Hospital Dept of Neurology
  • The Minneapolis Clinic of Neurology
  • University of Minnesota Medical School, Dept of Neurology
  • Nevada Neurological Consultants
  • Albany Medical College Dept of Neurology MC-70
  • Neurology University of Rochester
  • SUNY At Stony Brook U Hospital - Department of Neurology
  • SUNY Upstate Medical University Dept of Neurology
  • MS Center/CHS
  • Wake Forest Univ. Health Sciences
  • Ohio State University
  • Oak Clinic for Multiple Sclerosis
  • Medford Neurological and Spine Clinic
  • University Of Pennsylvania
  • Thomas Jefferson University Physicians Dept of Neurology
  • Baptist West Hospital
  • University of Texas-Houston
  • Central Texas Neurology
  • Neurology Health Care Service / Fletcher Allen Health Care
  • Neurology Center of Fairfax
  • Blue Ridge Research Center
  • Minor & James Medical, PLLC
  • CAMC Institute
  • Center for Neurological Disorders
  • Servicio de Neurologia
  • Departmento Enfermedades Desmielinizantes
  • Servicio de Neurologia Departmento Enfermedades Desmielinizantes
  • Seccion Neurolgia Instituto INEBA
  • Fundacion Rosarina de Neurorehabilitacion
  • Dept Neurologia Sanatorio Britanico de Rosario
  • OO Landes-Nervenklinik
  • Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
  • Dept of Neurology CHU Timone
  • Hopital Pontchaillou
  • Dept of Neurology Johannes Gutenberg University
  • Dept of Neurology Universitatsklinikum Munster
  • Dept of Neurological and Psychiatric Sciences University of Bari
  • Dept of Neurosciences Oftamology and Genetics Univ of Genoa
  • Dept Neurology Ospedale San Raffaele
  • Dept of Neurological Sciences University La Sapienza Rome
  • Academisch Ziekenhuis Vrije Universiteit
  • MS Center Nijmegen
  • City Clinical Hospital No 83
  • Dept Of Neurology and Neurosurgery, Russian State Med Univ
  • State Instituion Central Clinical Milatary Hospital
  • Scientific Research Center of Neurology Russian MOH
  • Department of Neurology City Hospital #33
  • Institute of Clinical Immunology RAMS
  • Military Medical Academy
  • Dept of Neurology St Petersburg State Medical University
  • Dept of MS Institute for Human Brain of R.A.Sci
  • Dept of Neurology Medical Clinic of Russian MoH
  • Chair of Nuerological Diseases and Medical Genetics
  • Neuroinmunologia Clinica Hospital Vall d'Hebron
  • Servicio de Neurologia Hospital Bellvitge
  • Neurologia Hospital Carlos Haya
  • Unidad de EM Neurologia Hospital Virgen Macarena
  • Dept Of Neurology
  • Department of Neurology
  • Department Of Neurology Royal London Hospital
  • Royal Victoria Infirmary
  • Div of Clinical Neurology B Floor Medical School Univ Hospital
  • Division of Clinical Neurology Medical School Universtity Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rebif®

Copaxone®

Arm Description

Outcomes

Primary Outcome Measures

Time to First Relapse
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2004
Last Updated
September 15, 2017
Sponsor
EMD Serono
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00078338
Brief Title
Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Official Title
Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 16, 2004 (Actual)
Primary Completion Date
November 28, 2006 (Actual)
Study Completion Date
November 28, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
764 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rebif®
Arm Type
Experimental
Arm Title
Copaxone®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rebif®
Other Intervention Name(s)
Recombinant interferon beta-1a
Intervention Description
Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
Intervention Type
Drug
Intervention Name(s)
Copaxone®
Other Intervention Name(s)
Glatiramer acetate
Intervention Description
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Primary Outcome Measure Information:
Title
Time to First Relapse
Description
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.
Time Frame
Baseline up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between 18 and 60 years of age Have definite relapsing multiple sclerosis Have had one or more relapses within the prior 12 months Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1 Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized Be willing and able to comply with the protocol for the duration of the study Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care Exclusion Criteria: Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS) Prior use of any interferon or glatiramer acetate Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI) Have a psychiatric disorder that is unstable or would preclude safe participation in the study. Have significant leukopenia (white blood cell count < 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1. Have elevated liver function tests (alanine aminotransferase [AST], aspartate aminotransferase [ALT], alkaline phosphatase > 2.0 times the upper limit of normal [ULN] of the central laboratory, or total bilirubin > 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced) Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1 Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1 Prior use of cladribine or have received total lymphoid irradiation Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1. Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus [HIV], human T-cell lymphotrophic virus type I [HTLV-1]) Have had plasma exchange in 3 months prior to Study Day 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Barrow Neurology Clinics
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Northwest NeuroSpecialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Neurology
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Advanced Neurology of Colorado, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
The MS Treatment Center at Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Neurological Center of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Harbourside Medical Plaza
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
Consultants In Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
University of Maryland MD Center for MS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital Dept of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
The Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
University of Minnesota Medical School, Dept of Neurology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Nevada Neurological Consultants
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Albany Medical College Dept of Neurology MC-70
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Neurology University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY At Stony Brook U Hospital - Department of Neurology
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University Dept of Neurology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
MS Center/CHS
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Forest Univ. Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oak Clinic for Multiple Sclerosis
City
Uniontown
State/Province
Ohio
ZIP/Postal Code
44685
Country
United States
Facility Name
Medford Neurological and Spine Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Physicians Dept of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baptist West Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
University of Texas-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Neurology Health Care Service / Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Neurology Center of Fairfax
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Blue Ridge Research Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Minor & James Medical, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
CAMC Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Servicio de Neurologia
City
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Departmento Enfermedades Desmielinizantes
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Servicio de Neurologia Departmento Enfermedades Desmielinizantes
City
Buenos Aires
ZIP/Postal Code
C118ACH
Country
Argentina
Facility Name
Seccion Neurolgia Instituto INEBA
City
Buenos Aires
ZIP/Postal Code
C1192AAW
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
ZIP/Postal Code
CP 2000
Country
Argentina
Facility Name
Dept Neurologia Sanatorio Britanico de Rosario
City
Rosario
Country
Argentina
Facility Name
OO Landes-Nervenklinik
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
City
Riberao Preto-SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Dept of Neurology CHU Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Dept of Neurology Johannes Gutenberg University
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Dept of Neurology Universitatsklinikum Munster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Dept of Neurological and Psychiatric Sciences University of Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Dept of Neurosciences Oftamology and Genetics Univ of Genoa
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Dept Neurology Ospedale San Raffaele
City
Milan
Country
Italy
Facility Name
Dept of Neurological Sciences University La Sapienza Rome
City
Rome
ZIP/Postal Code
00185
Country
Italy
Facility Name
Academisch Ziekenhuis Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Facility Name
MS Center Nijmegen
City
Nijmegen
ZIP/Postal Code
6533 PA
Country
Netherlands
Facility Name
City Clinical Hospital No 83
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
Dept Of Neurology and Neurosurgery, Russian State Med Univ
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
State Instituion Central Clinical Milatary Hospital
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Scientific Research Center of Neurology Russian MOH
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Department of Neurology City Hospital #33
City
Nizhniy Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Institute of Clinical Immunology RAMS
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Military Medical Academy
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Dept of Neurology St Petersburg State Medical University
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Dept of MS Institute for Human Brain of R.A.Sci
City
St Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Dept of Neurology Medical Clinic of Russian MoH
City
St Petersburg
Country
Russian Federation
Facility Name
Chair of Nuerological Diseases and Medical Genetics
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Neuroinmunologia Clinica Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Servicio de Neurologia Hospital Bellvitge
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Neurologia Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Unidad de EM Neurologia Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Dept Of Neurology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Department of Neurology
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Department Of Neurology Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Div of Clinical Neurology B Floor Medical School Univ Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Division of Clinical Neurology Medical School Universtity Hopsital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18789766
Citation
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.
Results Reference
result

Learn more about this trial

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

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