Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
NCT00078338
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
- 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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Descriptive Information | ||||
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |