Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects

NCT00101959 | Withdrawn Phase 4

• 1 other identifier: 25277
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized to either continue on their current therapy or receive Rebif therapy. The subjects will be followed for 2 years. The primary objective is to compare the time to worsening to a medium level of concern as defined by the Canadian Multiple Sclerosis Working Group (CMSWG) treatment optimization recommendations.

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

Rebif DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent (and HIPAA authorization for USA subjects) before any study-related procedure, not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to future medical care
• Age between 18 and 60 years (inclusive)
• Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis based on Poser or McDonald criteria
• Results of an MRI scan acquired within 2 years of screening, consistent with MS.
• Duration of MS ≤ 7 years from onset of symptoms
• Receiving consistent therapy with Avonex®, or Copaxone® for ≥ 2 years (Subjects that have converted from one therapy to another or who have used other disease-modifying therapies (DMTs) within two years of Screening will be excluded).
• Expanded Disability Status Score (EDSS) of 0 to ≤ 5.5, inclusive
• Exhibiting low or medium level of concern based on number and severity of relapses within 12 months prior to screening (subjects who have reached a high level of concern at any time within the past 12 months will be excluded); \*Low Level of Concern: a) 1 mild relapse (Mild severity - corticosteroids not required, minimal effect on Activities of Daily Living (ADL), only 1 Kurtzke Functional Systems (KFS) functional domain affected, no or mild motor/cerebellar involvement, no need for treatment or hospitalization and prompt recovery); \*Medium Level of Concern: a) 2 mild relapses or 1 moderate relapse (Moderate severity - corticosteroids may be required, at most moderate effect on ADL, \>1 KFS functional domain may be affected, moderate motor/cerebellar involvement, may require treatment but not hospitalization and incomplete recovery at 3 months but complete recovery by 6 months)
• Clinical stability or improving neurological state during the eight weeks before Study Day 1
• Willingness and ability to comply with the protocol for the duration of the study
• If female, she must either:
• be post-menopausal or surgically sterilized; or
• use a hormonal contraceptive, intrauterine 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 30 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is required for all females that are of childbearing potential.

You may not qualify if:

• Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
• Progressive forms of MS (Primary progressive, Secondary progressive)
• Exhibiting a high level of concern based on number and severity of relapses at any time in the 12 months prior to screening; \*High Level of Concern a) 3 mild, 2 moderate or 1 severe relapse (Severe Severity- Corticosteroids and hospitalization required, severe effect on ADL, \>1 KFS functional domain may be affected, severe motor/cerebellar involvement, impact on ADL and incomplete recovery at 6 months)
• Subjects who have been on DMTs other than Avonex® or Copaxone® in the two years prior to screening.
• Subjects with history of intolerance to Interferon Beta
• History of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the Rebif® formulation including mannitol
• History of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the Rebif® formulation including mannitol
• Participation in any other studies involving investigational or marketed products, concomitantly or within 3 months prior to Study Day 1
• Treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 or ongoing chronic treatment with systemic corticosteroids.
• Treatment with immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, Campath) within the 12 months prior to Study Day 1
• Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
• Prior use of cladribine or have received total lymphoid irradiation
• Prior use of Antegren® (natalizumab)
• Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 3 months prior to Study Day 1
• Psychiatric disorder that is unstable or would preclude safe participation in the study

Sponsors & Collaborators

• EMD Serono: lead

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2005
• First Posted: January 19, 2005
• Study Start: November 1, 2004
• Last Updated: August 6, 2013

Record last verified: 2013-08