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

NCT00232193 | Completed

• 1 other identifier: 011-03-AVX
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-remitting Multiple Sclerosis; Clinically Isolated Syndrome

Keywords

Multiple Sclerosis; Interferon Beta 1-a; Pulsed steroids

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naive MS patients with either RRMS or CIS, of either gender, between 18 to 55 years of age inclusive, with baseline EDSS of 0 to 3.5, fulfilling McDonald criteria for MS or CHAMPS criteria for CIS, were randomly assigned to one of two treatment groups.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence Multiple Sclerosis Center: lead
• Biogen: collaborator

Study Sites (1)

Providence MS Center

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stanley L. Cohan, M.D., Ph.D.

  Providence Multiple Sclerosis Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: December 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

US (1)