Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis



Status:Terminated
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:November 2007
End Date:December 2008

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An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the
treatment of relapsing forms of multiple sclerosis.

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous
TERMS study will immediately be eligible for Tovaxin production and treatment in this open
label extension study. The MRTC negative subjects will be monitored quarterly for safety,
MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during
the monitoring phase will then be eligible for Tovaxin production and treatment in this
study.

Inclusion Criteria:

- Subjects who completed the TERMS study and received at least 1 study treatment
injection

- Signed and dated statement of informed consent

Exclusion Criteria:

- Pregnancy or breastfeeding

- Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin
in the TERMS study.

- Withdrew from TERMS study and did not continue participating in the remaining 52-week
core TERMS study assessments.

- Non-compliant with TERMS study.

- Diagnosis of progressive-relapsing, secondary progressive or primary progressive
Multiple Sclerosis (MS) while enrolled in the TERMS study.

- Medical, psychiatric or other conditions that compromise the subject's ability to
give informed consent, to understand the patient information, to comply with the
study protocol, or to complete the study.

- Any significant change in the subject's medical condition after enrollment in the
TERMS study which would have lead to his/her exclusion from participation in that
study.
We found this trial at
27
sites
Northbrook, Illinois 60062
1716
mi
from 98109
Northbrook, IL
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8550 Marshall Dr.
Lenexa, Kansas 66214
913-894-1500
1501
mi
from 98109
Lenexa, KS
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Pompano Beach, Florida 33060
2712
mi
from 98109
Pompano Beach, FL
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
1775
mi
from 98109
San Antonio, TX
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2039
mi
from 98109
Akron, OH
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Albany, New York 12205
2348
mi
from 98109
Albany, NY
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2300
mi
from 98109
Augusta, GA
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675
mi
from 98109
Berkeley, CA
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Bradenton, Florida 34205
2543
mi
from 98109
Bradenton, FL
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Charlotte, North Carolina 28204
2282
mi
from 98109
Charlotte, NC
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Colorado Springs, Colorado 80919
1060
mi
from 98109
Colorado Springs, CO
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Columbus, Ohio 43221
2008
mi
from 98109
Columbus, OH
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2051
mi
from 98109
Cullman, AL
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Dayton, Ohio
1959
mi
from 98109
Dayton, OH
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Fort Wayne, Indiana 46805
1873
mi
from 98109
Fort Wayne, IN
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1890
mi
from 98109
Houston, TX
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Kirkland, Washington 98034
8
mi
from 98109
Kirkland, WA
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Lebanon, New Hampshire 03766
2393
mi
from 98109
Lebanon, NH
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Lexington, Kentucky 40513
2005
mi
from 98109
Lexington, KY
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2417
mi
from 98109
Mineola, NY
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
2371
mi
from 98109
Philadelphia, PA
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1116
mi
from 98109
Phoenix, AZ
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Phoenix, Arizona 85050
1103
mi
from 98109
Phoenix, AZ
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147
mi
from 98109
Portland, OR
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Raleigh, North Carolina 27607
2358
mi
from 98109
Raleigh, NC
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Round Rock, Texas 78681
1760
mi
from 98109
Round Rock, TX
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1858
mi
from 98109
Saginaw, MI
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