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Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Mycophenolate Mofetil (CellCept) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Elliot M Frohman, MD/PhD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas

Summary

The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in size and number of lesions on MRI scans.

Clinical Details

Official title: A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in MRI

Secondary outcome:

Secondary Objectives:

Changes in exacerbation frequency, incidence of exacerbations in the treated groups, changes in level of sustained disability

, changes in quality of life measures, assessment of fatigue

Detailed description: Sixty patients (20 patients at each recruiting center) with RR MS who satisfy both inclusion and exclusion criteria will be treated with CellCept® or Avonex® for the first 6 months of the study. Those patients will have a fifty-fifty chance of receiving either Avonex or Cellcept. Baseline data will be collected before treatment begins including MRIs, chest x-ray, EKG, and standard labwork, along with a blood test for HIV and Hepatitis B. Once enrolled, study visits include periodic MRI scans, a neurological exam by the examining neurologist every three months, frequent bloodwork, questionnaires, and eye-testing at month zero, six, and twelve months. Eye testing takes about one hour and requires dilation of pupils. All assessments are standard of care for ophthalmology with the exception of optical coherence tomography (OCT)-- a non-invasive procedural device that records graphical and numerical measurements of the optic nerve and macula. All patients will begin active combination therapy on both CellCept® and Avonex® during the second 6 months of the study. During this second phase, MRI and clinical examinations will be performed.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient diagnosed with clinically definite MS according to McDonald criteria #1-#4

- Age 18-55

- Have a RR disease course

- Have EDSS scores less than or equal to 5. 0

- Have a disease duration of one day to 20 years

- Have at least one medically documented clinical relapse within the 12 months prior to

randomization (for eligibility, a pre-study relapse will be defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute MS relapse; the relapse does not need to have been treated to qualify) and/or have progression of ≥1. 0 points in EDSS in the previous year

- Have ≥1 Gd-enhancing brain lesion on a monthly run-in baseline MRI and ≥2 T2 brain

lesions consistent with MS on the screening scan

- Signed informed consent

- None of the exclusion criteria

Exclusion Criteria:

- Previous treatment 3 months prior to study entry with standard disease-modifying

therapy (interferon-beta and glatiramer acetate, IVIG and plasmaphoresis).

- Previous treatment 12 months prior to study entry with immunosuppressant agents,

e. g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies (e. g., azathioprine, methotrexate,, CellCept®, natalizumab, and other immunomodulators/monoclonal agents).

- Patients who received steroid treatment 30 days prior to the MRI scan date

- Women who are pregnant, lactating or of childbearing age who do not consent to

approved contraceptive use during the study.

- Abnormal blood tests, performed during the screening visit (see adverse events

section)

Locations and Contacts

Michigan Institute for Neurological Disorders (M.I.N.D.), Farmington Hills, Michigan 48334, United States

Buffalo Neuroimaging Analysis Center (BNAC), Buffalo, New York 14203, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States

Additional Information

Starting date: May 2006
Last updated: June 17, 2013

Page last updated: August 20, 2015

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