Recruiting October 2003 – February 2004
RAPIDS-2
A RAndomized, double-blind, Placebo-controlled, multi-center study to assess the effect of bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis.
Sponsor: Actelion Pharmaceuticals Ltd
Principal Investigators: (J. Korn, Boston University and J. Seibold, UMDNJ)
Study drug: Bosentan 125 mg b.i.d.
Design: Multicenter, randomized, double-blind, placebo-controlled, phase III study.
Outcome Measures:
Primary – Time to healing of the cardinal ulcer
– Number of new digital ulcers during the treatment period.
Secondary – Hand functionality indices.
– Hand pain
Patient Selection Criteria:
Inclusion Criteria (main):
Cardinal ulcers are ulcers that are > 1 week and < 3 months old, on the fingertip or ventral finger surface. Eligibility will be determined at study site.
Exclusion Criteria (main):
Centers involved (site participation depends on IRB/ regulatory approval):
USA
University of Colorado Hospital, Denver, CO, Dr. Collier, 1 720-848-1940 dcollier@dhha.org
Froedtert / Medical College, Milwaukee, WI, Dr. Csuka, 1 414 456 7024 mecsuka@mcw.edu
Tulane University Health Sciences Center, New Orleans, LA, Dr. Doyle, 1 504 588 5578 mdoyle1@tulane.edu
University of Chicago Hospitals, Chicago, IL, Dr. Ellman, 1 773 702 1226 mellman@medicine.bsd.uchicago.edu
University of Alabama at Birmingham, Birmingham, AL, Dr. Fessler, 1 205 934 2813 Barri.Fessler@ccc.uab.edu
UCLA School of Medicine, Los Angeles, CA, Dr. Furst, 1 310-206-5366 defurst@mednet.ucla.edu
North Shore University Hospital, Manhasset, NY, Dr. Goldberg, 1 516 562 4392 augoldbe@lij.edu
University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, Dr. Hsu, 1 732 235 8934 hsuvm@umdnj.edu
Thomas Jefferson University, Philadelphia, PA, Dr. Jimenez, 1 215 503 5042 sergio.jimenez@mail.tju.edu
Ruppert Health Center, Toledo, OH, Dr. Kahaleh, 1 419 383 4271 bkahaleh@mco.edu
Spokane Rheumatology Group, Spokane, WA, Dr. Kenney, 1 509 838 6500 hkenney@arthritisnw.com
Boston University Medical Center, Boston, MA, Dr. Korn, 1 617 638 4486 jkorn@bu.edu
Michigan State University, Grand Rapids, MI, Dr. Martin, 1 616 459 8088 martinr3@msu.edu
University of Texas, Houston, TX, Dr. Mayes, 1 713 500 6900 maureen.d.mayes@uth.tmc.edu
University of Pittsburgh, Pittsburgh, PA, Dr. Medsger, 1 412 383 8765 medsger@msx.dept-med.pitt.edu
Virginia Mason Research Center, Seattle, WA, Dr. Molitor, 1 206 223 6836 rhejam@vmmc.org
Mayo Clinic, Rochester, MN, Dr. Osborn, 1 507 284 8450 osborn.thomas@mayo.edu
University of Connecticut Health Center, Farmington, CT, Dr. Rothfield, 1 860 679 3604 rothfield@nso.uchc.edu
The Center for Rheumatology, Albany, NY, Dr. Shapiro, 1 518 489 4471 lshapiro@joint-docs.com
Medical University of South Carolina, Charleston, SC, Dr. Smith, 1 843 792 3484 smithed@musc.edu
John Hopkins University School of Medicine, Baltimore, MD, Dr. Wigley, 1 410 955 3375 fwig@jhmi.edu or fwigley1@jhmi.edu
Canada
SMBD-Jewish General Hospital, Montreal, Quebec, Dr. Baron, 1 514 340 8234 mbaron@rhu.jgh.mcgill.ca
Mount Sinai Hospital, Toronto, Ontario, Dr. Lee, 1 416 586 7747 Plee@mtsinai.on.ca
St Joseph's Health Care London, London, Ontario, Dr. Pope, 1 591 646 6332 janet.pope@sjhc.london.on.ca
Hôpital Notre-Dame, Montreal, Quebec, Dr. Rich, 1 514 890 8000 eric.rich@sympatico.ca
The Ottawa Hospital, Ottawa, Ontario, Dr. Smith, 1 613 737 8176 DSMITH@ogh.on.ca
Europe
Time Line:
To date, one clinical trial, RAPIDS-1, has been performed in the same indication
including scleroderma patients with or without digital ulcers at baseline. The
RAPIDS-1 study showed that bosentan reduces significantly the number of new
digital ulcers versus placebo. The safety profile of bosentan observed in the
RAPIDS-1 study was similar to that observed in pulmonary hypertension, an
indication currently approved in the countries where the RAPIDS-2 study is
performed.