Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
This study has been completed.
Information provided by:
First received: February 23, 2004
Last updated: August 5, 2014
Last verified: April 2011
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.
Relapsing-remitting Multiple Sclerosis
Drug: Human interferon beta-1a and glatiramer acetate
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years to 60 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- 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.
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
||Bruno Musch, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 23, 2004
||August 5, 2014
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs