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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Drug: Copaxone®

Drug: Rebif®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00078338

24735

Details and patient eligibility

About

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.

Enrollment

764 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care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-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.