An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:August 2009
End Date:February 2016

Use our guide to learn which trials are right for you!

This open-label, rater-blinded extension study will enroll patients who have
relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior
Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348)
also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes
of this study are:

1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who
received alemtuzumab as their study treatment in one of the prior studies.

2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for
patients who received Rebif® (interferon beta-1a) as their study treatment in one of
the prior studies.

3. To determine if and when further alemtuzumab treatment is needed, and the safety and
efficacy of this "as needed" treatment. This applies both to patients who received
alemtuzumab for the first time in one of the prior studies or for the first time in
this extension study.

Alemtuzumab treatment will either be on a fixed schedule of two treatment cycles a year
apart for patients who received Rebif® in one of the prior Genzyme-sponsored studies of
alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed MS
activity) for patients who have already completed a fixed schedule of treatment with
alemtuzumab in one of the prior Genzyme-sponsored studies. There is no comparison treatment
in this study. All patients will be required to return to their study site every 3 months
for neurologic and other assessments. In addition, safety-related laboratory tests and
surveys will be performed at least monthly. Participation in the extension study will last
48 months from enrollment. Study duration may be extended per protocol amendments to allow
patients to remain in the study through the time of drug approval or until a long term
follow up study is available in each respective country.

Inclusion Criteria:

- 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period,
and have not subsequently received disease modifying treatments (other than
glatiramer acetate or interferon beta); or

- 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and
have not subsequently received alternative disease modifying treatments (other than
glatiramer acetate or another interferon beta); or

- 3.Participated in CAMMS223.

- NOTE: Criteria 1 and 2 above mean that patients who enrolled in CAMMS323 or CAMMS324
but did not complete the 2-year study period or went on to receive non-study drug
DMTs after randomization are not eligible for inclusion in the Extension Study.
Patients who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria
1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

- Any alemtuzumab patient from CAMMS223, CAMMS323, or CAMMS324 who has received
alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or
is participating in any other investigational study, unless approved by Genzyme. In
addition, these patients must be screened for disqualifying safety concerns before
receiving alemtuzumab retreatment.

- Any Rebif® patient from CAMMS223, CAMMS323, or CAMMS324 who meets any of the
following criteria. In addition, these patients must be screened for disqualifying
safety concerns before receiving alemtuzumab treatment. a)Does not wish to receive
alemtuzumab; b) Ongoing participation in any other investigational study, unless
approved by Genzyme; c)Has received alemtuzumab off-label (ie, outside of one of the
prior Genzyme-sponsored studies); d)Known bleeding disorder or therapeutic
anticoagulation; e)Diagnosis of idiopathic thrombocytopenia purpura or other
autoimmune hematologic abnormality; f)History of malignancy, except basal cell skin
carcinoma; g)Intolerance of pulsed corticosteroids, especially a history of steroid
psychosis h)Significant Autoimmune disorder (other than MS); i)Major psychiatric
disorder or epileptic seizures not adequately controlled by treatment; j)Active
infection or high risk for infection k)Unwilling to use a reliable and acceptable
contraceptive method during and for at least 6 months following each alemtuzumab
treatment cycle (fertile patients only).
We found this trial at
70
sites
Knoxville, Tennessee 37916
777
mi
from
Knoxville, TN
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
1038
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
8550 Marshall Dr.
Lenexa, Kansas 66214
913-894-1500
188
mi
from
Lenexa, KS
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
618
mi
from
Nashville, TN
Click here to add this to my saved trials
Pompano Beach, Florida 33060
1303
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
564
mi
from
San Antonio, TX
Click here to add this to my saved trials
2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
1116
mi
from
Tampa, FL
Click here to add this to my saved trials
1111
mi
from
Tampa, FL
Click here to add this to my saved trials
5860 N. La Cholla Blvd.
Tucson, Arizona 85704
520-742-1833
834
mi
from
Tucson, AZ
Click here to add this to my saved trials
524
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1208
mi
from
Allentown, PA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
401
mi
from
Aurora, CO
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1330
mi
from
Berkeley, CA
Click here to add this to my saved trials
Boston, Massachusetts
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Buenos Aires,
5602
mi
from
Buenos Aires,
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
609
mi
from
Chicago, IL
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
898
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton Twp, Michigan
?
mi
from
Clinton Twp, MI
Click here to add this to my saved trials
Cordova, Tennessee 38018
481
mi
from
Cordova, TN
Click here to add this to my saved trials
664
mi
from
Cullman, AL
Click here to add this to my saved trials
Des Moines, Iowa
347
mi
from
Des Moines, IA
Click here to add this to my saved trials
347
mi
from
Des Moines, IA
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
714
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Franklin, Tennessee 37064
617
mi
from
Franklin, TN
Click here to add this to my saved trials
Ft. Collins, Colorado
435
mi
from
Ft. Collins, CO
Click here to add this to my saved trials
733
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1055
mi
from
Jacksonville, FL
Click here to add this to my saved trials
196
mi
from
Kansas City, KS
Click here to add this to my saved trials
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
1154
mi
from
La Habra, CA
Click here to add this to my saved trials
Latham, New York 12110
1309
mi
from
Latham, NY
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
1393
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Kentucky 40513
721
mi
from
Lexington, KY
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
657
mi
from
Louisville, KY
Click here to add this to my saved trials
Maitland, Florida 32751
1138
mi
from
Maitland, FL
Click here to add this to my saved trials
1305
mi
from
Mineola, NY
Click here to add this to my saved trials
New Haven, Connecticut
1344
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York
1225
mi
from
New York, NY
Click here to add this to my saved trials
1225
mi
from
New York, NY
Click here to add this to my saved trials
Northbrook, Illinois 60062
608
mi
from
Northbrook, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Pasadena, California 91105
1162
mi
from
Pasadena, CA
Click here to add this to my saved trials
Patchogue, New York 11772
1338
mi
from
Patchogue, NY
Click here to add this to my saved trials
Phoenix, Arizona 85050
842
mi
from
Phoenix, AZ
Click here to add this to my saved trials
852
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
1185
mi
from
Reno, NV
Click here to add this to my saved trials
1122
mi
from
Rochester, NY
Click here to add this to my saved trials
499
mi
from
Round Rock, TX
Click here to add this to my saved trials
San Antonio, Texas 78258
576
mi
from
San Antonio, TX
Click here to add this to my saved trials
1142
mi
from
Sarasota, FL
Click here to add this to my saved trials
Scottsdale, Arizona 85259
834
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington
1410
mi
from
Seattle, WA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
1329
mi
from
Stanford, CA
Click here to add this to my saved trials
1194
mi
from
Syracuse, NY
Click here to add this to my saved trials
Teaneck, New Jersey
1286
mi
from
Teaneck, NJ
Click here to add this to my saved trials
Traverse City, Michigan 49684
793
mi
from
Traverse City, MI
Click here to add this to my saved trials
Uniontown, Ohio 44685
903
mi
from
Uniontown, OH
Click here to add this to my saved trials
Vienna, Virginia 22182
1114
mi
from
Vienna, VA
Click here to add this to my saved trials
Washington, District of Columbia 20037
1127
mi
from
Washington,
Click here to add this to my saved trials
976
mi
from
Winston Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01605
1406
mi
from
Worcester, MA
Click here to add this to my saved trials