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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00078338
First received: February 23, 2004
Last updated: August 5, 2014
Last verified: April 2011
  Purpose

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: 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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078338

  Show 80 Study Locations
Sponsors and Collaborators
EMD Serono
Pfizer
Investigators
Study Director: Bruno Musch, MD EMD Serono
  More Information

No publications provided by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00078338     History of Changes
Other Study ID Numbers: 24735
Study First Received: February 23, 2004
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Copolymer 1
Interferon beta 1a
Interferon-beta
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014