Status:
COMPLETED
Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Brief Summary
The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis population than in general population. These MS patients category response unfavorably to the Interferon. The ...
Detailed Description
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than 400,000 individuals in the United States, and 2.5 million worldwide (www.nationalmssociety.org). The main pat...
Eligibility Criteria
Inclusion
- Clinically definite multiple sclerosis defined by McDonald Criteria.
- Between 18-60 years of age.
- Subject must able to understand and sign the IRB- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol.
- Subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
- Subjects must have officially diagnosed and documented co-morbid, other than MS, autoimmune condition (psoriasis, vasculitis, thyroiditis or rheumatoid arthritis).
- At the time of enrollment patients were on beta IFN (Avonex, Betaseron or Rebif) treatment for at least 3 months.
Exclusion
- Women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years postmenopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
- Any clinically significant general health conditions that may interfere with the trial participation.
- Subject has a history of drug or alcohol abuse within the past year.
- Subject had corticosteroid treatment within last 90 days.
- Subject started new medication within last 30 days.
- Subject is a participant in another research project.
- Subject has contraindications for GA treatment.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01456416
Start Date
September 1 2011
End Date
April 1 2013
Last Update
April 4 2013
Active Locations (1)
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1
USC MS Comprehensive Care Center & Research Group
Los Angeles, California, United States, 90033