EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinica
EARLY IFNb-1a (Rebif) and Atorvastatin (Lipitor) Combination Therapy of Isolated Clinical Syndrome Suggestive of 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
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
To determine the effects of IFNb-1a plus atorvastatin versus IFNb-1a plus placebo on the gene expression in peripheral blood mononuclear cells (PBMCs) derived from patients with isolated clinical syndrome suggestive of MS
2 years
Immune responseTo identify markers of therapeutic response and to predict patients' clinical response based on their in vitro response to this combination therapy measured by the gene expression levels in activated PBMCs
2 years
Immune response
Other measures (1)
evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS.
2 years
Safety
Who could take part
Early (CIS/RIS) · 18 to 60 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* Patients with isolated clinical syndrome suggestive of MS * At least three out of four magnetic resonance imaging (MRI) findings on the initial scan: * One Gd-enhancing lesion or nine T2 hyperintense lesions; * At least one infratentorial lesion; * At least one juxtacortical lesion; and * At least three periventricular lesions. * Expanded Disability Status Scale (EDSS) 0-5.5 * 18 to 60 years of age * At least one relapse in previous 12 months
Exclusion criteria
* Patients with a diagnosis of clinically definitive relapsing-remitting (RR) MS, secondary progressive, or primary progressive MS. * Patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (TLI). * Patients treated with IFNb-1a, IFNb-1b, glatiramer acetate, intravenous immunoglobulins (IVIg), plasma exchange, methotrexate, or azathioprine in the previous 3 months. * Patients treated with intravenous or oral steroids within 30 days prior to baseline MRI. * Patients who have been treated with statins in the previous 3 months. * Pregnant or breast-feeding women. * Patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease. * Abnormal baseline blood tests including alanine transaminase (ALT) or aspartate transaminase (AST) greater than twice the upper limit of normal
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif) and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to predict patients' clinical response based on their in vitro response to this combination therapy measured by the gene expression levels in activated peripheral blood mononuclear cells (PBMCs).
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History
Started
Oct 2004
Main results due
Oct 2007
Finished
Oct 2008