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Relapsing-remitting Multiple SclerosisPhase 4NCT00078338

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

A Phase 4 study testing Rebif® and Copaxone® in people with Relapsing-remitting Multiple Sclerosis, run by EMD Serono at 80 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Relapsing-remitting Multiple Sclerosis
What is being tested?
Rebif® and Copaxone®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
764 participants
Where
80 sitesin 12 countries
Study dates
16 Feb 2004to 28 Nov 2006
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

80 sites in 12 countries.

80 sites in 12 countries

United States41 sites

  • Albany Medical College Dept of Neurology MC-70

    Albany, New York, 12208

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • Shepherd Center

    Atlanta, Georgia, 30309

  • University of Maryland MD Center for MS

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Neurology Health Care Service / Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • CAMC Institute

    Charleston, West Virginia, 25304

  • MS Center/CHS

    Charlotte, North Carolina, 28207

  • University Chicago Hospitals

    Chicago, Illinois, 60619

  • Ohio State University

    Columbus, Ohio, 43210

  • The MS Treatment Center at Griffin Hospital

    Derby, Connecticut, 06418

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Hospital Dept of Neurology

    Detroit, Michigan, 48202

  • Neurology Center of Fairfax

    Fairfax, Virginia, 22031

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • The Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Nevada Neurological Consultants

    Henderson, Nevada, 89052

  • University of Texas-Houston

    Houston, Texas, 77030

  • Baptist West Hospital

    Knoxville, Tennessee, 37922

  • Medford Neurological and Spine Clinic

    Medford, Oregon, 97504

  • Neurological Center of South Florida

    Miami, Florida, 33176

  • Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215

  • University of Minnesota Medical School, Dept of Neurology

    Minneapolis, Minnesota, 55455

  • Consultants In Neurology, Ltd.

    Northbrook, Illinois, 60062

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Physicians Dept of Neurology

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurology Clinics

    Phoenix, Arizona, 85013

  • Blue Ridge Research Center

    Roanoke, Virginia, 24014

  • Neurology University of Rochester

    Rochester, New York, 14642

  • Central Texas Neurology

    Round Rock, Texas, 78681

  • University of California, Davis

    Sacramento, California, 95817

  • Kaiser Permanente Neurology

    San Diego, California, 92102

  • Minor & James Medical, PLLC

    Seattle, Washington, 98104

  • SUNY At Stony Brook U Hospital - Department of Neurology

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University Dept of Neurology

    Syracuse, New York, 13210

  • Harbourside Medical Plaza

    Tampa, Florida, 33606

  • Northwest NeuroSpecialists

    Tucson, Arizona, 85741

  • Oak Clinic for Multiple Sclerosis

    Uniontown, Ohio, 44685

  • Wake Forest Univ. Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Russia11 sites

  • City Clinical Hospital No 83

    Moscow, 115682

  • Dept Of Neurology and Neurosurgery, Russian State Med Univ

    Moscow, 117049

  • State Instituion Central Clinical Milatary Hospital

    Moscow, 123182

  • Scientific Research Center of Neurology Russian MOH

    Moscow, 125367

  • Department of Neurology City Hospital #33

    Nizhny Novgorod, 603076

  • Institute of Clinical Immunology RAMS

    Novosibirsk, 630099

  • Military Medical Academy

    Saint Petersburg, 194044

  • Dept of Neurology St Petersburg State Medical University

    Saint Petersburg, 197022

  • Dept of MS Institute for Human Brain of R.A.Sci

    Saint Petersburg, 197376

  • Dept of Neurology Medical Clinic of Russian MoH

    Saint Petersburg

  • Chair of Nuerological Diseases and Medical Genetics

    Yaroslavl, 150030

Other trials in Russia

Argentina6 sites

  • Servicio de Neurologia

    Buenos Aires, 1221

  • Departmento Enfermedades Desmielinizantes

    Buenos Aires, 1428

  • Servicio de Neurologia Departmento Enfermedades Desmielinizantes

    Buenos Aires, C118ACH

  • Seccion Neurolgia Instituto INEBA

    Buenos Aires, C1192AAW

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, CP 2000

  • Dept Neurologia Sanatorio Britanico de Rosario

    Rosario

Other trials in Argentina

United Kingdom5 sites

  • Department Of Neurology Royal London Hospital

    London, E1 1BB

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Div of Clinical Neurology B Floor Medical School Univ Hospital

    Nottingham, NG7 2UH

  • Division of Clinical Neurology Medical School Universtity Hopsital

    Nottingham, NG7 2UH

  • Department of Neurology

    Whitechapel, London, E1 1BB

Other trials in United Kingdom

Italy4 sites

  • Dept of Neurological and Psychiatric Sciences University of Bari

    Bari, 70124

  • Dept of Neurosciences Oftamology and Genetics Univ of Genoa

    Genoa, 16132

  • Dept Neurology Ospedale San Raffaele

    Milan

  • Dept of Neurological Sciences University La Sapienza Rome

    Rome, 00185

Other trials in Italy

Spain4 sites

  • Neuroinmunologia Clinica Hospital Vall d'Hebron

    Barcelona, 08035

  • Servicio de Neurologia Hospital Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Neurologia Hospital Carlos Haya

    Málaga, 29010

  • Unidad de EM Neurologia Hospital Virgen Macarena

    Seville, 41009

Other trials in Spain

France2 sites

  • Dept of Neurology CHU Timone

    Marseille, 13385

  • Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Germany2 sites

  • Dept of Neurology Johannes Gutenberg University

    Mainz, 55131

  • Dept of Neurology Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

Netherlands2 sites

  • Academisch Ziekenhuis Vrije Universiteit

    Amsterdam, 1081

  • MS Center Nijmegen

    Nijmegen, 6533 PA

Other trials in Netherlands

Austria1 site

  • OO Landes-Nervenklinik

    Linz, 4020

Other trials in Austria

Brazil1 site

  • Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo

    Riberao Preto-SP, 14048-900

Other trials in Brazil

Switzerland1 site

  • Dept Of Neurology

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Being tested
Rebif®, Copaxone®
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rebif®Drug

    Also called Recombinant interferon beta-1a

    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).

  • Copaxone®Drug

    Also called Glatiramer acetate

    Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).

Study groups in NCT00078338
Study groupRoleWhat they receive
Rebif®ExperimentalNot described
Receives: Drug: Rebif®
Copaxone®Active comparatorNot described
Receives: Drug: Copaxone®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2004 (estimated)
  2. Study start16 Feb 2004
  3. Primary completion28 Nov 2006
  4. Study completion28 Nov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
764 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078338
Sponsor's protocol ID
24735
Status last verified
Sep 2017
First submitted
23 Feb 2004
Last updated
27 Jun 2018

Publications

  • 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.

    PubMed 18789766

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rebif® and Copaxone® in people with Relapsing-remitting Multiple Sclerosis, run by EMD Serono at 80 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Russia, Argentina, United Kingdom, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Relapse (time frame: Baseline up to 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078338, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.

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