Last updated on February 2018

Low-dose Glucocorticoid Vasculitis Induction Study

Brief description of study

Previous reports suggested conventional immunosuppressants such as cyclophosphamide could not reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because of lower remission rate and higher relapse rate. However those reports didn't include rituximab.

B cell depletion therapy by rituximab is a new strategy for remission induction in ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe relapsing ANCA-associated vasculitis.

Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy between low-dose and high-dose glucocorticoid plus rituximab). Participants will be randomised to the "low-dose glucocorticoid plus rituximab" or the high-dose glucocorticoid plus rituximab" groups. Primary endpoint is proportion of remission at 6 months, then data regarding relapse and long-term safety will be collected until 24 months.

The study has been designed by the principal and coordinating investigators. It will include 140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and Chiba East Hospital.

Detailed Study Description

ANCA (anti-neutrophil cytoplasmic antibody)-associated vasculitis is characterised by small vessel vasculitis and presence of autoantibodies, ANCA. It can be a life-threatening disease with renal/respiratory failure. Current standard therapy in induction remission for ANCA-associated vasculitis is combination of high-dose glucocorticoid and IV-cyclophosphamide. This regimen is effective (remission rate; 80-90%), but often cause various glucocorticoid-related side effects. Especially, infection is related to death. Thus a new regimen reducing glucocorticoid dose is required.

Clinical Study Identifier: NCT02198248

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Shinichiro Kagami, M.D., Ph.D

Asahi General Hospital
Asahi, Japan
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Noboru Hagino, M.D., Ph.D.

Teikyo University Medical Centre
Ichihara, Japan
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Shinsji Motoshima, M.D., Ph.D.

Kameda Medical Centre
Kamogawa, Japan
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Tsuyoshi Umibe, M.D., Ph.D

Matsudo City Hospital
Matsudo, Japan
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Yasushi Nawata, M.D., Ph.D

Saiseikai Narashino Hospital
Narashino, Japan
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Masaki Hiraguri, M.D., Ph.D

Japanese Red Cross Narita Hospital
Narita, Japan
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Iwao Sekikawa, M.D., Ph.D

Juntendo University Urayasu Hospital
Urayasu, Japan
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Yohei Seto, M.D., Ph.D

Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo, Japan
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Takao Sugiyama, M.D., Ph.D

Shimoshizu Hospital
Yotsukaido, Japan
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Yoshiya Tanaka, MD, PhD

University of Occupational and Environmental Health
Kitakyushu, Japan
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Tatsuya Atsumi, MD, PhD

Hokkaido University
Sapporo, Japan
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Taichi Hayashi, M.D., Ph.D

Hitachinaka General Hospital
Hitachinaka, Japan
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Takayuki Sumida, M.D., Ph.D

University of Tsukuba
Tsukuba, Japan
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Hidehiro Yamada, M.D., Ph.D.

St. Marianna University School of Medicine Hospital
Kawasaki, Japan
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Yoshiaki Ishigatsubo, M.D., Ph.D

Yokohama City University
Yokohama, Japan
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Yasuhiko Kita, M.D., Ph.D

Yokohama Rosai Hospital
Yokohama, Japan
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Shuichi Ikeda, M.D., Ph.D.

Shinshu University
Matsumoto, Japan
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Kouichi Amano, M.D., Ph.D

Saitama Medical Center
Kawagoe, Japan
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Kazuhiro Kurasawa, M.D., Ph.D

Dokkyo Medical University
Mibu, Japan
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Hajime Kono, M.D., Ph.D

Teikyo University
Itabashi, Japan
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Tsutomu Takeuchi, MD, PhD

Keio University Hospital
Shinanomachi, Japan
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Akio Mimori, M.D., Ph.D

National Center for Global Health and Medicine
Shinjyuku, Japan
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Atsushi Komatsuda, MD, PhD

Akita University
Akita, Japan
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Hiroshi Nakajima, M.D., Ph.D

Chiba University Hospital
Chiba, Japan
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Yoshihisa Kobayashi, M.D., Ph.D

Chiba Aoba Municipal Hospital
Chiba, Japan
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Ryutaro Matsumura, M.D., Ph.D

Chiba East Hospital
Chiba, Japan
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Hiroshi Watanabe, M.D., Ph.D.

Fukushima Medical University
Fukushima, Japan
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Atsushi Kawakami, MD, PhD

Nagasaki University
Nagasaki, Japan
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Ichiei Narita, M.D., Ph.D.

Niigata University
Niigata, Japan
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Atsushi Kumanogoh, MD, PhD

Osaka University
Osaka, Japan
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Recruitment Status: Open

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