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Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis

NCT00223301 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-04-22

No results posted yet for this study

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

Conditions

Interventions

DRUG

Mycophenolate Mofetil (cellcept)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Biogen

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Elliot Frohman, MD/PhD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00223301 on ClinicalTrials.gov