NCT00137176

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

August 26, 2005

Last Update Submit

June 22, 2009

Conditions

Multiple Sclerosis

Keywords

Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 PBMCs

    2 years

Secondary Outcomes (1)

  • evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS.

    2 years

Study Arms (1)

Rebif + Lipitor

EXPERIMENTAL
Drug: Rebif

Interventions

RebifDRUG

Rebif 44mcg TIW

Rebif + Lipitor

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • to 60 years of age
  • At least one relapse in previous 12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina-Chapel Hill MS Clinic Within the Neuroscience Hospital

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Silva Markovic-Plese

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2008

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

US(1)