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

NCT00324506 | Completed Phase 2 DMC

• 2 other identifiers: IIT 355349IRB #012006-028
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• Secondary Objectives:

  one year

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

  one year

• , changes in quality of life measures, assessment of fatigue

  one year

Study Arms (1)

Cellcept and Avonex

ACTIVE COMPARATOR

Drug: Mycophenolate Mofetil (CellCept)

Interventions

Mycophenolate Mofetil (CellCept) DRUG

Cellcept and Avonex

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Aspreva Pharmaceuticals: collaborator

Study Sites (3)

Michigan Institute for Neurological Disorders (M.I.N.D.)

Farmington Hills, Michigan, 48334, United States

Location

Buffalo Neuroimaging Analysis Center (BNAC)

Buffalo, New York, 14203, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Elliot M Frohman, MD/PhD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (3)