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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00324506
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by (Responsible Party):
Elliot Frohman, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE May 9, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE May 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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 [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • Secondary Objectives: [ Time Frame: one year ]
  • Changes in exacerbation frequency, incidence of exacerbations in the treated groups, changes in level of sustained disability [ Time Frame: one year ]
  • , changes in quality of life measures, assessment of fatigue [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis
Official Title  ICMJE 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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Mycophenolate Mofetil (CellCept)
Study Arms  ICMJE Active Comparator: Cellcept and Avonex
Intervention: Drug: Mycophenolate Mofetil (CellCept)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
43
Original Enrollment  ICMJE
 (submitted: May 9, 2006)
60
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324506
Other Study ID Numbers  ICMJE IIT 355349
IRB #012006-028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elliot Frohman, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Aspreva Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Elliot M Frohman, MD/PhD University of Texas, Southwestern Medical Center at Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP