Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities

Completed

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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 investigators suggest that autoimmune co morbidity can serve as a biological marker predicting good response to GA.

Key facts

Study ID

NCT01456416

Run by

University of Southern California

People needed

10

Starts

2011-09-01

Expected to finish

2013-04-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC MS Comprehensive Care Center & Research Group — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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