Safety Study of Combination Therapy With Intramuscular Avonex and Oral
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
What it found
We found no results in the registry or in papers.
This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Mycophenolate mofetil
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
What it measured
Main measures
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
Safety
Other measures (8)
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.
Disability progressionTo document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
Mood and sleepQuality of life (reported by participants)To assess fatigue with the validated fatigue assessment inventory
FatigueNeuroimmunological studies:At baseline, 6 and 12 months after treatment.
Pharmacodynamics.
Genetic Studies.
Who could take part
Relapsing MS · 21 to 45
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
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History
Started
Jul 2004
Main results due
Mar 2007
Finished
Mar 2007