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Mar. 26, 2014 |
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Oct. 10, 2019 |
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jRCT1091220173 |
Effect of MMF on interstitial lung disease associated with collagen vascular diseases (MMF for CVD-ILD) |
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Effect of MMF on interstitial lung disease associated with collagen vascular diseases |
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Mar. 31, 2019 |
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Six males, 11 females, 17 in total, the average age was 57. Ten cases of polymyositis or dermatomyositis (including ADM). Six cases of systemic sclerosis. One patient has dermatomyositis complicated with systemic sclerosis. |
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Because this study was a single-arm open-label, the underlying diseases consisted of PM/DM and SSc, and only 17 cases were registered in total, we could not make a conclusion about safety. |
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Because this study was a single-arm open-label, the underlying diseases consisted of PM/DM and SSc, and only 17 cases were registered in total, we could not make a conclusion about efficacy. |
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This study had various limitations. We found, however, one case in which interstitial lung disease improved after the addition of MMF to the previous treatment. The results suggest that MMF might be one of the most effective treatment options for interstitial lung diseases associated with collagen vascular diseases. |
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https://link.springer.com/article/10.1007%2Fs10067-016-3443-2 https://onlinelibrary.wiley.com/doi/full/10.1002/rcr2.235 |
Toshinori Takada |
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Niigata University Medical and Dental Hospital |
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1-754, Asahimachi-dori, Chuo-ku, Niigata |
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+81-25-227-0378 |
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ttakada@med.niigata-u.ac.jp |
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Toshinori Takada |
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Niigata University Medical and Dental Hospital |
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1-754, Asahimachi-dori, Chuo-ku, Niigata |
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+81-25-227-0378 |
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ttakada@med.niigata-u.ac.jp |
COMPLETED |
Nov. 12, 2011 |
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| 20 | ||
Interventional |
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Nonrandomized trial (quasi-experiment) |
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open(masking not used) |
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No |
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N/A |
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interstitial lung disease associated with collagen vascular diseases resistant to conventional therapy |
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physician's decision |
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| No limit | ||
| No limit | ||
Both |
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interstitial lung disease associated with collagen vascular diseases |
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Intervention type:DRUG Name of intervention:mycophenolate mofetil,mycophenolate mofetil Dose form / Japanese Medical Device Nomenclature:CAPSULE,CAPSULE Route of administration / Site of application:ORAL,ORAL Dose per administration:15,500 20,500 mg/kg,mg Dosing frequency / Frequency of use:BID,BID [BID],[BID] Planned duration of intervention:6 months,6 months Intended dose regimen:Add mycophenolate mofetil to glucocorticoid and cyclosporin,mycophenolate mofetil only or add it to glucocorticoid therapy detailes of teratment arms:rapidly progressive interstitial lung disease associated with collagen vascular diseases,progressive interstitial lung disease associated with systemic sclerosis Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: |
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safety |
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efficacy |
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| Toshinori Takada | |
| Toshiaki Kikuchi |
| Niigata University Medical and Dental Hospital |
| Niigata University Medical School Ethics Committee | |
| Yes | |
Sept. 09, 2009 |
| JMA-IIA00173 | |
| Japan |