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

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ClinicalTrials.gov Identifier: NCT00078338
Recruitment Status : Completed
First Posted : February 26, 2004
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
EMD Serono

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.

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Rebif® Drug: Copaxone® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2004
Actual Primary Completion Date : November 28, 2006
Actual Study Completion Date : November 28, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rebif® Drug: Rebif®
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).
Other Name: Recombinant interferon beta-1a

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




Primary Outcome Measures :
  1. Time to First Relapse [ Time Frame: Baseline up to 96 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078338


  Show 80 Study Locations
Sponsors and Collaborators
EMD Serono
Pfizer
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

Publications of Results:
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Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00078338     History of Changes
Other Study ID Numbers: 24735
First Posted: February 26, 2004    Key Record Dates
Results First Posted: June 27, 2018
Last Update Posted: June 27, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
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Glatiramer Acetate
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
(T,G)-A-L
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents