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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mycophenolate Mofetil (CellCept)
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Michigan Institute for Neurological Disorders (M.I.N.D.)
  • Buffalo Neuroimaging Analysis Center (BNAC)
  • University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Cellcept and Avonex

Arm Description

Outcomes

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

Full Information

First Posted
May 9, 2006
Last Updated
June 17, 2013
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Aspreva Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00324506
Brief Title
Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Aspreva Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cellcept and Avonex
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil (CellCept)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary Objectives:
Time Frame
one year
Title
Changes in exacerbation frequency, incidence of exacerbations in the treated groups, changes in level of sustained disability
Time Frame
one year
Title
, changes in quality of life measures, assessment of fatigue
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot M Frohman, MD/PhD
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Institute for Neurological Disorders (M.I.N.D.)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Buffalo Neuroimaging Analysis Center (BNAC)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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