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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00101959
• Date of registration: 18/01/2005
• Prospective Registration: No
• Primary sponsor: EMD Serono
• Public title: Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects
• Scientific title: An Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy
• Date of first enrolment: November 2004
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00101959
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

1. be post-menopausal or surgically sterilized; or

2. use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or
condom with spermicide, for the duration of the study; and

3. be neither pregnant nor breast-feeding.

4. 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.

- The small minority of subjects for whom Rebif therapy is not reimbursed by their
insurance carrier may be considered for the study if otherwise eligible, but will
require prior approval from the sponsor for coverage of the cost of their Rebif
therapy

Exclusion Criteria:

- 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

- Cognitive impairment which impairs ability to understand or comply with the protocol
procedures

- Any laboratory value reaching Grade 2 toxicity or greater within 30 days of Study Day
1 based on Common Terminology Criteria for Adverse Events (CTACE) criteria

- Specific systemic diseases, (including insulin-dependent diabetes, Lyme disease,
clinically significant cardiac disease, HIV, HTLV-1, and Hepatitis B or C), or other
uncontrolled major medical conditions (depression, seizure disorder) that would
interfere with the participant's safety, compliance or evaluation

- Unable and/or unlikely to follow the protocol for any reason

- Alcohol and/or any other drug abuse

- Likelihood of requiring treatment during the study period with drugs not permitted by
the study protocol

- Abnormal baseline clinical findings considered by the investigator to be indicative
of conditions that might affect study results



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: Rebif

Secondary ID(s)

25277

Source(s) of Monetary Support

Please refer to primary and secondary sponsors