Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS

Sponsor

Providence Multiple Sclerosis Center (Other)

Overall Status

Completed

CT.gov ID

NCT00232193

Collaborator

Biogen (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis Clinically Isolated Syndrome

Detailed Description

Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex, as well as reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such as short courses of corticosteroids.

This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
IFNβ+DS group IFNβ+DS group received lyophilized Avonex 30mcg IM weekly plus dexamethasone 160 mg IV every 4 weeks for 52 weeks and was treated with Avonex 30mcg IM weekly from week 53 to 104
IFNβ group IFNβ group received lyophilized Avonex 30mcg IM weekly for 104 weeks

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

male and female patients between the ages of 18-55 years inclusive
have provided informed consent to be screened for the study
have been diagnoses as having MS
meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
have an EDSS score of 0.0-3.5
have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments

Exclusion Criteria:

type I of type II diabetes
uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
history of suicidal ideation
history of psychosis
history of alcoholism or other substance abuse
clinically significant coronary artery disease
history of hepatic failure and chronic renal failure
history of cancer other than basal or squamous cell carcinoma of the skin
pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
nursing mothers
history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
history of peptic ulcer disease
history of intolerance to corticosteroids or allergy to albumin
history of osteoporosis
history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
unwillingness or inability to comply with all the requirements of the protocol
known diagnosis of osteoporosis