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

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Trial Conditions
  • Multiple Sclerosis, Relapsing-Remitting
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Both

Eligibility

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).

Gender: Both
Steward Physician(s)
  • Medical Monitor
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • alemtuzumab
  • alemtuzumab
Physician Researcher

Investigator Name:

  • Medical Monitor

Other Information

Sponsor: Genzyme
Phase: Phase 3
Trial ID: NCT00930553
Volunteers:  Not Accepting Healthy Volunteers

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