Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
Public ClinicalTrials.gov record NCT00223301. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00223301
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2004 (Type not available)
- Primary completion
- Mar 2007 (Actual)
- Completion
- Mar 2007 (Actual)
- Last update posted
- Apr 22, 2013
2004 – 2007
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8806 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00223301, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2013 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00223301 live on ClinicalTrials.gov.