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

NCT00078338

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Relapsing-remitting Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Relapsing-remitting Multiple SclerosisRebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
NCT00078338
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Tucson, Arizona
  4. Sacramento, California
  5. San Diego, California
  6. Fort Collins, Colorado
  7. Derby, Connecticut
  8. Fairfield, Connecticut
  9. Miami, Florida
  10. Tampa, Florida
  11. Atlanta, Georgia
  12. Chicago, Illinois
  13. Northbrook, Illinois
  14. Fort Wayne, Indiana
  15. Baltimore, Maryland
  16. Ann Arbor, Michigan
  17. Detroit, Michigan
  18. Detroit, Michigan
  19. Golden Valley, Minnesota
  20. Minneapolis, Minnesota
  21. Henderson, Nevada
  22. Albany, New York
  23. Rochester, New York
  24. Stony Brook, New York
  25. Syracuse, New York
  26. Charlotte, North Carolina
  27. Winston-Salem, North Carolina
  28. Columbus, Ohio
  29. Uniontown, Ohio
  30. Medford, Oregon
  31. Philadelphia, Pennsylvania
  32. Philadelphia, Pennsylvania
  33. Knoxville, Tennessee
  34. Houston, Texas
  35. Round Rock, Texas
  36. Burlington, Vermont
  37. Fairfax, Virginia
  38. Roanoke, Virginia
  39. Seattle, Washington
  40. Charleston, West Virginia
  41. Milwaukee, Wisconsin
  42. Buenos Aires,
  43. Buenos Aires,
  44. Buenos Aires,
  45. Buenos Aires,
  46. Rosario,
  47. Rosario,
  48. Linz,
  49. Riberao Preto-SP,
  50. Marseille,
  51. Rennes cedex,
  52. Mainz,
  53. Munster,
  54. Bari,
  55. Genoa,
  56. Milan,
  57. Rome,
  58. Amsterdam,
  59. Nijmegen,
  60. Moscow,
  61. Moscow,
  62. Moscow,
  63. Moscow,
  64. Nizhniy Novgorod,
  65. Novosibirsk,
  66. Saint-Petersburg,
  67. St Petersburg,
  68. St Petersburg,
  69. St Petersburg,
  70. Yaroslavl,
  71. Barcelona,
  72. Hospitalet de Llobregat,
  73. Malaga,
  74. Sevilla,
  75. Zurich,
  76. Whitechapel, London
  77. London,
  78. Newcastle upon Tyne,
  79. Nottingham,
  80. Nottingham,
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  3. Creteil,
  4. Dijon,
  5. Limoges,
  6. Lomme,
  7. Lyon,
  8. Marseille,
  9. Montpellier,
  10. Nancy,
  11. Nice,
  12. Paris,
  13. Paris,
  14. Paris,
  15. Paris,
  16. Strasbourg,
  17. Toulouse,
  18. Bari,
  19. Firenze,
  20. Gallarate,
  21. Genova,
  22. Milano,
  23. Torino,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-remitting Multiple Sclerosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Rebif®
    Intervention: Drug: Rebif®
  • Active Comparator: Copaxone®
    Intervention: Drug: Copaxone®
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2006)
764
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 28, 2006
Actual Primary Completion Date November 28, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-?, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   France,   Germany,   Italy,   Netherlands,   Russian Federation,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00078338
Other Study ID Numbers  ICMJE 24735
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMD Serono
Study Sponsor  ICMJE EMD Serono
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical ResponsibleMerck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP