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Sponsors and Collaborators: |
Tokyo Medical and Dental University Japan Medical Association Astellas Pharma Inc |
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Information provided by: | Tokyo Medical and Dental University |
ClinicalTrials.gov Identifier: | NCT00504348 |
The purpose of the study is to evaluate the efficacy and safety of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis with comparison against corticosteroid-treated historical controls.
Condition | Intervention | Phase |
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Interstitial Pneumonitis Polymyositis Dermatomyositis |
Drug: Tacrolimus |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-Treated Historical Controls |
Ages Eligible for Study: | 16 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Experimental treatment group
Meet two or more of the following criteria (must include 1) 1. Serum KL-6 above the upper normal limit 2. Presence of dyspnea on exertion (grade 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index 3. PaO2 of less than 80 mmHg while breathing ambient air at rest, not accompanied by abnormal increase of PaCO2 4. Vital capacity < 80% predicted, or diffusing capacity for carbon monoxide < 65% predicted 5. Meet at least one of the following condition over the 12-week period (84 days) prior to the initiation of the study drug
Historical control group
Meet two or more of the following criteria (must include 1) 1. Serum KL-6 above the upper normal limit 2. Presence of dyspnea on exertion (grade 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index 3. PaO2 of less than 80 mmHg while breathing ambient air at rest, not accompanied by abnormal increase of PaCO2 4. Vital capacity < 80% predicted, or diffusing capacity for carbon monoxide < 65% predicted 5. Meet at least one of the following condition over the 12-week period (84 days) prior to the initiation of the study drug
Exclusion Criteria:
Experimental treatment group
Historical control group
Contact: Kazuki Takada, MD | +81-3-5803-4818 | imppact.rheu@tmd.ac.jp |
Japan | |
Chiba University Hospital | Recruiting |
Chiba, Japan, 260-8677 | |
Contact: Norihiko Watanabe, MD, PhD +81-43-226-2093 nwatanabe@faculty.chiba-u.jp | |
Principal Investigator: Norihiko Watanabe, MD, PhD | |
Sub-Investigator: Koichi Hirose, MD, PhD | |
Sub-Investigator: Kei Ikeda, MD, PhD | |
Sub-Investigator: Hideki Hanaoka, MD, PhD | |
Nagasaki University Hospital of Medicine and Dentistry | Recruiting |
Nagasaki, Japan, 852-8501 | |
Contact: Atsushi Kawakami, MD, PhD +81-95-849-7266 atsushik@net.nagasaki-u.ac.jp | |
Principal Investigator: Atsushi Kawakami, MD, PhD | |
Sub-Investigator: Tomoki Origuchi, MD, PhD | |
Sub-Investigator: Hiroaki Ida, MD, PhD | |
Sub-Investigator: Hideki Nakamura, MD, PhD | |
Sub-Investigator: Keita Fujikawa, MD | |
Sub-Investigator: Katsumi Eguchi, MD, PhD | |
Tokushima University Hospital | Recruiting |
Tokushima, Japan, 770-8503 | |
Contact: Jun Kishi, MD, PhD +81-88-633-7127 kishijun@clin.med.tokushima-u.ac.jp | |
Principal Investigator: Jun Kishi, MD, PhD | |
Sub-Investigator: Saburo Sone, MD, PhD | |
Sub-Investigator: Kenji Tani, MD, PhD | |
Sub-Investigator: Yasuhiko Nishioka, MD, PhD | |
Sub-Investigator: Kenya Sumitomo, MD, PhD | |
Sub-Investigator: Yoshinori Aono, MD, PhD | |
Sub-Investigator: Momoyo Azuma, MD, PhD | |
Sub-Investigator: Katsuhiro Kinoshita, MD | |
Sub-Investigator: Hideki Makino, MD | |
Japan, Hokkaido | |
Hokkaido University Hospital | Recruiting |
Sapporo, Hokkaido, Japan, 060-8648 | |
Contact: Tatsuya Atsumi, MD, PhD +81-11-716-1161 at3tat@med.hokudai.ac.jp | |
Principal Investigator: Tatsuya Atsumi, MD, PhD | |
Sub-Investigator: Tetsuya Horita, MD, PhD | |
Sub-Investigator: Shinsuke Yasuda, MD, PhD | |
Sub-Investigator: Hiroshi Kataoka, MD, PhD | |
Sub-Investigator: Toshiyuki Bougaki, MD, PhD | |
Japan, Ibaraki | |
Tsukuba University Hospital | Recruiting |
Tsukuba, Ibaraki, Japan, 305-8576 | |
Contact: Satoshi Ito, MD, PhD +81-29-853-3900 s-ito@md.tsukuba.ac.jp | |
Principal Investigator: Satoshi Ito, MD, PhD | |
Sub-Investigator: Takayuki Sumita, MD, PhD | |
Sub-Investigator: Akito Tsutsumi, MD, PhD | |
Sub-Investigator: Isao Matsumoto, MD, PhD | |
Sub-Investigator: Daisuke Goto, MD, PhD | |
Japan, Osaka | |
Osaka Minami Medical Center | Recruiting |
Kawachinagano, Osaka, Japan, 586-8521 | |
Contact: Yoshinori Katada, MD, PhD +81-721-53-5761 kataday@omh.hosp.go.jp | |
Principal Investigator: Yoshinori Katada, MD, PhD | |
Sub-Investigator: Yoshinori Harada, MD, MPharm | |
Sub-Investigator: Takao Yamanaka, MD | |
Sub-Investigator: Yukihiko Saeki, MD, PhD | |
Sub-Investigator: Shiro Oshima, MD, PhD | |
Sub-Investigator: Masato Matsushita, MD, PhD | |
Sub-Investigator: Eriko Tanaka, MD | |
Japan, Tokyo | |
Tokyo Medical and Dental University Hospital | Recruiting |
Bunkyo-ku, Tokyo, Japan, 113-8519 | |
Contact: Kazuki Takada, MD +81-3-5803-4818 imppact.rheu@tmd.ac.jp | |
Principal Investigator: Nobuyuki Miyasaka, MD, PhD | |
Sub-Investigator: Kazuki Takada, MD | |
Sub-Investigator: Hitoshi Kohsaka, MD, PhD | |
Sub-Investigator: Tetsuro Kubota, MD, PhD | |
Sub-Investigator: Masayoshi Harigai, MD, PhD | |
Sub-Investigator: Ryuji Koike, MD, PhD | |
Sub-Investigator: Toshihiro Nanki, MD, PhD | |
Sub-Investigator: Yoshinori Nonomura, MD, PhD | |
Sub-Investigator: Yukiko Komano, MD, PhD | |
Sub-Investigator: Michi Tanaka, MD, PhD | |
Keio University Hospital | Recruiting |
Shinjuku-ku, Tokyo, Japan, 160-8582 | |
Contact: Michito Hirakata, MD, PhD +81-3-5363-3786 mhirakat@sc.itc.keio.ac.jp | |
Principal Investigator: Michito Hirakata, MD, PhD | |
Sub-Investigator: Masataka Kuwana, MD, PhD | |
Sub-Investigator: Shinji Sato, MD, PhD | |
Sub-Investigator: Yuko Kaneko, MD | |
International Medical Center of Japan | Recruiting |
Shinjuku-ku, Tokyo, Japan, 162-8655 | |
Contact: Kenji Itoh, MD, PhD +81-3-3202-7181 kenito@imcj.hosp.go.jp | |
Principal Investigator: Kenji Itoh, MD, PhD | |
Sub-Investigator: Akio Mimori, MD, PhD | |
Sub-Investigator: Akitake Suzuki, MD, PhD | |
Sub-Investigator: Hiroyuki Yamashita, MD | |
Sub-Investigator: Yuko Takahashi, MD | |
Juntendo University Hospital | Recruiting |
Bunkyo-ku, Tokyo, Japan, 113-8431 | |
Contact: Yoshinari Takasaki, MD +81-3-3813-3111 tyoshi@med.juntendo.ac.jp | |
Principal Investigator: Yoshinari Takasaki, MD, PhD | |
Sub-Investigator: Naoto Tamura, MD, PhD | |
Sub-Investigator: Ken Yamaji, MD, PhD | |
Sub-Investigator: Shinji Morimoto, MD, PhD | |
Sub-Investigator: Hirohumi Amano, MD, PhD | |
Sub-Investigator: Makoto Ikeda, MD | |
Sub-Investigator: Hitoshi Ogasawara, MD, PhD | |
Sub-Investigator: Michihiro Ogasawara, MD, PhD | |
Sub-Investigator: Masakazu Matsushita, MD, PhD | |
Sub-Investigator: Ran Matsudaira, MD, PhD | |
Sub-Investigator: Kurisu Tada, MD, PhD | |
Sub-Investigator: Shoseki Ri, MD | |
The University of Tokyo Hospital | Recruiting |
Bunkyo-ku, Tokyo, Japan, 113-8655 | |
Contact: Kimito Kawahata, MD, PhD +81-3-3815-5411 ext 37267 kawabata-phy@h.u-tokyo.ac.jp | |
Principal Investigator: Kimito Kawahata, MD, PhD | |
Sub-Investigator: Noboru Hagino, MD | |
Sub-Investigator: Tetsuji Sawada, MD, PhD | |
Sub-Investigator: Ryoichi Tanaka, MD | |
Sub-Investigator: Keishi Fujio, MD, PhD |
Principal Investigator: | Nobuyuki Miyasaka, MD, PhD | Tokyo Medical and Dental University |
Study ID Numbers: | IICT-FK506-01 |
Study First Received: | July 19, 2007 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00504348 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Interstitial pneumonitis Polymyositis Dermatomyositis |
Tacrolimus Corticosteroids Interstitial pneumonitis associated with polymyositis or dermatomyositis |
Idiopathic Myopathy Lung Diseases, Interstitial Immunologic Factors Skin Diseases Methylprednisolone Methylprednisolone acetate Prednisolone acetate Tacrolimus Immunosuppressive Agents Myositis Dermatomyositis |
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Prednisolone Polymyositis Connective Tissue Diseases Pneumonia Methylprednisolone Hemisuccinate |
Lung Diseases, Interstitial Immunologic Factors Skin Diseases Physiological Effects of Drugs Nervous System Diseases Tacrolimus Immunosuppressive Agents Pharmacologic Actions Myositis Dermatomyositis |
Muscular Diseases Respiratory Tract Infections Musculoskeletal Diseases Neuromuscular Diseases Respiratory Tract Diseases Lung Diseases Polymyositis Connective Tissue Diseases Pneumonia |