Abbott Laboratories Protocol M03-654:
A 24-week, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Safety, Tolerability and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis with a 24- week Double Blind Active Extension Phase
Location: Multiple Centers throughout the US and Canada.
Purpose: The objective of the trial is to study the safety and effectiveness of ABT-874 administered weekly or every other week in patients with relapsing-remitting and secondary progressive multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans done periodically throughout the study.
Eligibility:
• Age between 18 to 55 years
• Diagnosis of active relapsing-remitting or secondary progressive multiple sclerosis
• At least one relapse within 12 months of screening
• Must be able to walk at least 65 feet with or without assistance
• MRI compatible with the diagnosis of MS with at least one Gd enhancing MRI lesions, but no more than 10 new Gd enhancing MRI lesions when compared to the first
• Off Copaxone or interferon therapy for 2 months prior to screening
• Able and willing to learn to self administer weekly injections, or have a designee who will administer study medication
• Female participants must use contraceptives while on study drug.
Procedure: The following procedures will be performed according the study schedule of 17 visits over a 48-week period of time; study drug injections, MRI brain scan, electrocardiogram, chest x-ray, vital signs, blood draws, physician and neurological assessments, urine pregnancy test (if applicable) and tuberculin skin test.
Benefit: May lead to a new treatment for RRMS and SPMS.
For Information:
Melissa Reznar, MPH, Study Coordinator
Wayne State University
8D University Health Center
4201 St. Antoine
Detroit, MI 48201
Phone: 313-966-5068
Fax: 313-966-9271
mreznar@med.wayne.edu
Amy Robillard, Study Coordinator
Alpine Clinical Research
1000 Alpine Avenue, Suite 200
Boulder, CO 80304
Phone: 303-443-7229
Fax: 303-443-7748
brownstone@alpineresearch.com
Priscilla Russo, Study Coordinator
MS Center
Carolinas Medical Center
1350 South Kings Drive
Charlotte, NC 28205
Phone: 704-446-1910
Fax: 704-446-1915
Priscilla.russo@carolinashealthcare.org
Gabriela Verdial, Study Coordinator
Marilyn Martinez, Study Coordinator
University of Miami––MS Center
1501 NW 9th Avenue
Miami, FL 33136
Phone: 305-243-1089
Phone: 305-243-1088
Fax: 305-243-1119
mmartinez13@med.miami.edu
Myra Edmunds, Study Coordinator
Upstate Clinical Research, LLC
3 Atrium Drive, Suite 205
Albany, NY 12205
Phone: 518-533-1500
Fax: 518-458-2293
salterman@upstateneurology.com
Donna Court, Study Coordinator
MS Center of Atlanta
MS Center of Georgia
3200 Down Wood Circle, Suite 550
Atlanta, GA 30327
Phone: 404-351-0205 ext. 104
Fax: 404-351-4556
d.court@mscatl.com
Ismari Clesson, Study Coordinator
Shepherd Center
2020 Peachtree Road, NW
Atlanta, GA 30309
Phone: 404-350-7651
Fax: 404-350-7596
Ismari_clesson@shepherd.org
Lou Dicave, Study Coordinator
Barrow Neurological Clinics, Suite 300
500 W. Thomas Road
Phoenix, AZ 85013
Phone: 602-406-7711
Fax: 602-406-6298
ldicave@chw.edu
1535 Lake Cook Road, Suite 601
Northbrook, IL 60062
Phone: 847-509-0270
Fax: 847-509-0273
e-mail-N/A
Location: Multi-centers throughout the US
Purpose: To compare the efficacy and safety of Betaserson® (interferon beta-1b) with Avonex® (interferon beta-1a) in patients with multiple sclerosis (MS) previously treated
with Avonex
Eligibility:
• Men and women ages 18 to 60
• Diagnosed with relapsing-remitting MS (RRMS)
• Currently treated with Avonex for at least 6 months.
Procedure: Participants will receive an injection of Betaseron every other day or Avonex once weekly.
Benefit: May lead to an improved treatment for RRMS.
For Information: To find out if there is a study center near you, please refer to www.abovestudy.com.