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Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With 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: NCT00223301
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
Roche Pharma AG
Biogen
Information provided by (Responsible Party):
Elliot Frohman, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE September 19, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE July 2004
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2006)
  • To document changes in exacerbation frequency
  • To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
  • To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
  • To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
  • To assess fatigue with the validated fatigue assessment inventory
  • Neuroimmunological studies:At baseline, 6 and 12 months after treatment.
  • Pharmacodynamics.
  • Genetic Studies.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
  • 1. To document changes in exacerbation frequency
  • 2. To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
  • 3. To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
  • 4. To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
  • 5. To assess fatigue with the validated fatigue assessment inventory
  • 6. Neuroimmunological studies:At baseline, 6 and 12 months after treatment.
  • 7. Pharmacodynamics.
  • 8. Genetic Studies.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
Official Title  ICMJE A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis
Brief Summary
  1. To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS.
  2. To document changes in exacerbation frequency,
  3. To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),
  4. To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI),
  5. To document changes in quality of life measures,
  6. To assess fatigue with the validated fatigue assessment inventory,
  7. Neuroimmunological studies:At baseline, 6 and 12 months after treatment
Detailed Description

Design: Uni-center, double-blind, randomized, placebo-controlled study of Avonex + placebo vs Avonex + Cellcept

Rationale: A number of immunopathogenic mechanisms have been hypothesized to figure prominently in the processes that culminate in the characteristic plaque lesion. These include the role of cytokines, chemokines, excitatory amino acids, free radicals, superoxides, and nitric oxide synthetase products. Recognizing that the disease process in MS involves a cascade of biological events, sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens. We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil (MMF), a novel agent with a broad spectrum of anti- inflammatory mechanisms.

  • Study population: MS patients who have been diagnosed with clinically definite, laboratory supported definite, or monosymptomatic MS meeting CHAMPS criteria ref , of either sex, who are between the ages of 21 and 50 inclusive.
  • Treatment Groups: 12 patients in each group, ALL patients on Intramuscular Avonex. Cellcept/Placebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week

Patients also see an examining physician every three months, have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis (done every six months).

  • Efficacy Parameters/Evaluations: EDSS, PSAT, MSFC and MRI, relapse rate and safety measures
  • Safety Parameters/Evaluations: Safety will be assessed by virtue of changes in T2/FLAIR lesions (number and volume) and in gadolinium enhancements (measured at 6 and 12 months after treatment initiation) compared to baseline measurements derived from one pretreatment run- in scan. In addition, a variety of clinical assessments will be performed for the period of 12 months of treatment. We will enroll 12 patients in each group (24 total)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Mycophenolate Mofetil (cellcept)
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: September 19, 2005)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Between the ages of 21-45 inclusive
  2. Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .
  3. At least one exacerbation in the preceding two years
  4. Written informed consent.

Exclusion Criteria:

  1. Primary progressive, secondary progressive or progressive relapsing MS.
  2. Corticosteroids during the 60 days prior to study entry.
  3. Treatment with plasma exchange within 90 days of preenrollment.
  4. No prior exposure to total lymphoid irradiation.
  5. No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs
  6. A clinical relapse within 60 days prior to enrollment.
  7. Pregnant/breastfeeding.
  8. Patients with major medical illnesses.
  9. Cognitive impairment interfering with ability to comply with the protocol.
  10. Patients who need to remain on any contraindicated medication.
  11. Diabetic
  12. Inability to undergo MRI scan
  13. On intravenous immunoglobulin protocol
  14. HIV+ or RPR+
  15. Females of childbearing age who have not undergone a sterilization procedure must be willing to practice effective birth control.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 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 NCT00223301
Other Study ID Numbers  ICMJE 1103-716
Has Data Monitoring Committee No
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
  • Roche Pharma AG
  • Biogen
Investigators  ICMJE
Principal Investigator: Elliot Frohman, MD/PhD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2013

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