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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

This open-label, rater-blinded extension study enrolled participants who had 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 were: 1. To examine the long term safety and efficacy of alemtuzumab treatment in participants 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 participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Key facts

Study ID

NCT00930553

Run by

Genzyme, a Sanofi Company

People needed

1314

Starts

2009-08-01

Expected to finish

2016-02-01

Last updated by the study team

2017-05-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had 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 had 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 meant that participants 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 were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.

You may not qualify if…

• Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
• Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had 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 participants only).

Where it is running

• HOPE Research Institute — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute — Phoenix, Arizona, United States
• Mayo Clinic Arizona (Scottsdale) — Scottsdale, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation — Berkeley, California, United States
• Neurology Center North Orange County — La Habra, California, United States
• University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center — Los Angeles, California, United States
• Neuro-Therapeutics, Inc. — Pasadena, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Health Science Center - Aurora — Aurora, Colorado, United States
• Advanced Neurology of Colorado — Fort Collins, Colorado, United States
• Yale MS Research Center — New Haven, Connecticut, United States
• The George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida Neuroscience Institute — Jacksonville, Florida, United States
• Neurology Associates, P.A. — Maitland, Florida, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Negroski, Stein, Sutherland and Hanes Neurology — Sarasota, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Emory University Department of Neurology — Atlanta, Georgia, United States
• Shepherd Center Multiple Sclerosis Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Consultants in Neurology, LTD — Northbrook, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• North Central Neurology Associates, P.C. — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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