重症川崎病患者に対する免疫グロブリン超大量+プレドニゾロン初期併用療法の効果を多施設共同無作為化比較試験実施計画書



Kawasaki disease is a vasculitic syndrome of unknown cause that occurs most often during childhood. It was first reported by Dr. Tomisaku Kawasaki in 1967. If untreated, about 25% of patients develop coronary arterial sequelae; however, the development of high-dose immunoglobulin therapy has decreased the incidence of such sequelae. Still, Kawasaki disease remains the most common cause of acquired heart disease in developed countries - over 1000 patients develop coronary arterial lesions each year in Japan alone. Thus, there is an urgent need for new treatments.



In the past, administration of steroids was contraindicated in patients with Kawasaki disease. Recently, however, administration of steroids for the treatment of acute Kawasaki disease is being reevaluated. The RAISE Study is a multicenter, randomized, controlled trial of the efficacy of initial immunoglobulin plus prednisolone combination therapy for patients with severe Kawasaki disease.

RAISE is an acronym for Randomized Controlled Trial to Assess Immunoglobulin Plus Steroid Efficacy for Kawasaki Disease.



Dr. Tsutomu Saji
Department of Pediatrics, Toho University Omori Medical Center
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Phone: +81-3-3762-4151
Fax: +81-3-3298-8217



Dr. Tohru Kobayashi
Department of Pediatrics, Gunma University Graduate School of Medicine
3-39-22 Showa-cho, Maebashi, Gunma Prefecture 371-8511, Japan
Phone: +81-27-220-8205
Fax: +81-27-220-8215



UMIN ID and password are needed to access the researcher-only site.



July 25, 2011: RAISE Study Protocol (E version) was released
June 12, 2010:
The number of registered patients has reached 200.
October 23, 2009:
The number of registered patients has reached 100.
June 18, 2009: The number of registered patients is now 75.
February 28, 2009: The number of registered patients is now 43.
January 22, 2009: The Third RAISE Study Group Meeting and an outcome presentation meeting will be held on 13 February.
December 28, 2008: The current number of registered patients is 19.
The current number of participating institutions is 43.
December 1, 2008: The current number of registered patients is 8.
The current number of participating institutions is 41.
November 20, 2008: Five institutions have newly become research participating institutions.
October 3, 2008: The first patient was registered with the RAISE Study.
September 29, 2008: Registration of patients with the RAISE Study begins.
July 30, 2008: Research-related documents are revised.
March 1, 2008: A site for general users opens.
February 6, 2008: A membership mailing list begins.
February 6, 2008: A researcher-only site opens.
January 12, 2007: Edition 1 of the research plan is drawn up.


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RAISE Study Group
The Ministry of Health, Labour and Welfare (MHLW) general research project to commercialize medical technology
A prospective, randomized, controlled study for examining the efficacy of initial immunoglobulin plus prednisolone combination therapy for severe Kawasaki disease