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 |
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.
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.
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
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Grand Rapids, Michigan
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Los Angeles, California
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Phoenix, Arizona
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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