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

Phase 1

• Conditions: Relapsing Remitting Multiple Sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-010788-18-NL
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patients must meet ONE of the following criteria to participate in the
Extension Study:
-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
-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
-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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified