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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 26, 2004
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
EMD Serono
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 mcg three times per week compared with Copaxone® 20 mg daily in patients with relapsing Multiple Sclerosis.

Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis Drug: Human interferon beta-1a and glatiramer acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Time to first relapse.

Enrollment: 764
Study Start Date: March 2004
Study Completion Date: September 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.
  • 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 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 MS or primary progressive MS.
  • Prior use of any interferon or glatiramer acetate.
  • Have had treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 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 (AST, 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 DTPA.
  • 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, HIV, HTLV-1).
  • Have had plasma exchange in 3 months prior to Study Day 1.
  Contacts and Locations
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
Study Director: Bruno Musch, MD EMD Serono
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00078338     History of Changes
Other Study ID Numbers: 24735
First Submitted: February 23, 2004
First Posted: February 26, 2004
Last Update Posted: October 12, 2017
Last Verified: April 2011

Additional relevant MeSH terms:
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
Interferon beta-1a
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents