Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis - Full Text View

Sponsors and Collaborators:	University of Texas Southwestern Medical Center Aspreva Pharmaceuticals
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00324506

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Mycophenolate Mofetil (CellCept)	Phase II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary Objectives: [ Designated as safety issue: No ]
Changes in exacerbation frequency, incidence of exacerbations in the treated groups, changes in level of sustained disability [ Designated as safety issue: No ]
, changes in quality of life measures, assessment of fatigue [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324506

Locations

United States, Michigan
Michigan Institute for Neurological Disorders (M.I.N.D.)
Farmington Hills, Michigan, United States, 48334
United States, New York
Buffalo Neuroimaging Analysis Center (BNAC)
Buffalo, New York, United States, 14203
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Aspreva Pharmaceuticals

Investigators

Principal Investigator:

Elliot M Frohman, MD/PhD

University of Texas Southwestern Medical Center at Dallas

More Information

No publications provided

Study ID Numbers:	IIT 355349, IRB #012006-028
Study First Received:	May 9, 2006
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00324506 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Interferons
Interferon-beta
Mycophenolic Acid
Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Immunosuppressive Agents
Anti-Bacterial Agents
Multiple Sclerosis
Interferon beta 1a
Mycophenolate mofetil
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Mycophenolic Acid
Enzyme Inhibitors
Sclerosis

Antibiotics, Antineoplastic
Multiple Sclerosis, Relapsing-Remitting
Immunosuppressive Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Mycophenolate mofetil
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009