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

This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, April 2007

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
Phase III

MedlinePlus related topics:   Multiple Sclerosis   

ChemIDplus related topics:   Mycophenolate Mofetil    Mycophenolate mofetil hydrochloride    Interferon alfa-2b    Interferons    Interferon beta    Interferon-beta    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

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   60
Study Start Date:   May 2006
Estimated Study Completion Date:   May 2008

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® with added placebo therapy for the first 6 months of the study. Those patients will have a fifty-fifty chance of receiving either combination of therapy: active Avonex with Cellcept placebo OR Avonex placebo with active Cellcept. Baseline data will be collected before treatment begins including a MRI, chest x-ray, EKG, and standard labwork, along with a blood test for HIV and Hepatitis B. Once enrolled, study visits include an MRI scan every month for the first six months, a neurological exam by the examining neurologist every three months, frequent bloodwork, questionnaires, and eye-testing at month zero and six. 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 at months 9, 10 and 12.

  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

Contacts
Contact: Gina M Remington, RN/BSN     214-645-0560     Gina.Remington@utsouthwestern.edu    
Contact: Elliot Frohman, MD/PhD     214-645-0557     Elliot.Frohman@utsouthwestern.edu    

Locations
United States, Michigan
Michigan Institute for Neurological Disorders (M.I.N.D.)     Recruiting
      Farmington Hills, Michigan, United States, 48334
      Contact: Sonda Lawson, MA, LLPC     248-553-0010     Sondall@aol.com    
      Contact: Howard Rossman, MD     248-553-0010     hsrossman@aol.com    
      Sub-Investigator: Howard Rossman, MD            
United States, New York
Buffalo Neuroimaging Analysis Center (BNAC)     Recruiting
      Buffalo, New York, United States, 14203
      Contact: Kara Patrick, MS, CCRC         KPatrick@KaleidaHealth.Org    
      Contact: Bianca Weinstock-Guttman, MD         BWeinstock-Guttman@KaleidaHealth.Org    
      Sub-Investigator: Robert Zivadinov, MD            
      Sub-Investigator: Bianca Weinstock-Guttman, MD            
United States, Texas
University of Texas Southwestern Medical Center at Dallas     Recruiting
      Dallas, Texas, United States, 75390
      Contact: Gina M Remington, RN/BSN     214-645-0560     Gina.Remington@utsouthwestern.edu    
      Principal Investigator: Elliot Frohman, MD/PhD            
      Sub-Investigator: Anjali Shah, MD            
      Sub-Investigator: Olaf Stuve, MD, PhD            

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


Study ID Numbers:   IIT 355349, IRB #012006-028
First Received:   May 9, 2006
Last Updated:   April 19, 2007
ClinicalTrials.gov Identifier:   NCT00324506
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Autoimmune Diseases
Demyelinating Diseases
Interferons
Mycophenolic Acid
Interferon-beta
Sclerosis
Demyelinating diseases
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Interferon beta 1a
Mycophenolate mofetil
Demyelinating Autoimmune Diseases, CNS
Interferon Alfa-2b
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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