Clinical trial NCT00292266: A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)
Official title: An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing-remitting Multiple Sclerosis
Rebif®
Avonex®
interferon-beta-1a
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono International SA
First posted: 2006-02-15
Enrollment: 677
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55 years
* Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria
* Two or more relapses within the preceding 24 months
* Clinical stability or improving neurological state during the 4 weeks before Study Day 1
* Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive
* Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI
* Willingness and ability to comply with the protocol for the duration of the study
* Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care
* For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized)

Exclusion Criteria:

* Secondary progressive MS, primary progressive MS or progressive relapsing MS
* Prior use of interferon
* Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI
* Psychiatric disorder that is unstable or will preclude safe participation in the study
* Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1
* Elevated liver function tests (Alanine transaminase \[ALT\], Aspartate transaminase \[AST\], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1
* Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1
* Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone
* Previous use of cladribine or total lymphoid irradiation
* Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA)
* Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1
* Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)

Primary outcomes:
measure: Percentage of exacerbation-free subjects
timeFrame: Week 24
measure: Percentage of exacerbation-free subjects
timeFrame: Week 48
measure: Percentage of exacerbation-free subjects
timeFrame: Week 72
Secondary outcomes:
measure: Mean number of combined unique (CU) active lesions per subject per scan
timeFrame: Week 24
measure: Total exacerbation count per subject
timeFrame: Week 24, 48 and 72
measure: Mean Number of Time constant 2 (T2) active lesions per subject per scan
timeFrame: Week 24, 48 and 72
Other outcomes:
Locations:
Study officials:
affiliation: Merck Serono International SA
name: Gordon Francis, M.D.
role: STUDY_DIRECTOR
References: