Unique ID issued by UMIN | UMIN000010126 |
---|---|
Receipt number | R000011860 |
Scientific Title | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease |
Date of disclosure of the study information | 2013/02/26 |
Last modified on | 2019/03/30 20:49:52 |
Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease
Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD
Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease
Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD
Japan |
Interstitial lung disease related to rheumatoid arthritis
Clinical immunology |
Others
NO
The purpose of this study is to evaluate efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in newly developed or recurrent cases of interstitial lung disease (categorized into either UIP, NSIP or OP pattern based on HRCT findings) related to rheumatoid arthritis
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
For cases with UIP/NSIP pattern ILD, improvement in forced vital capacity (FVC), which is defined as 10% or 200ml increase in FVC at week 24
For cases with OP pattern ILD, improvement of HRCT findings which is defined as 1 or more score improvement of Kazerooni score in affected lobes at week 24
Symptoms related to interstitial lung disease (Borg scale, MRC dyspnoea scale, UCSD shortness of breath questionnaire), improvement of HRCT findings (Kazerooni score), pulmonary function tests (change in FVC, diffusing capacity of the lung for CO), change in a serum marker (KL-6), a relapse rate of interstitial lung disease requiring increase in the dose of corticosteroid, activity of rheumatoid arthritis(SDAI, CDAI), adverse events, infectious events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.
20 | years-old | <= |
Not applicable |
Male and Female
Patients must meet the following criteria to be eligible for this study.
1. Fulfill the 2010 ACR/EULAR classification criteria for RA
2. Aged 20 years or older
3. Have newly developed or recurrent RA-related ILD, which is categorized as either UIP, NSIP or OP pattern based on HRCT findings. A patient who meets either of the following conditions.
1)A patient with newly developed RA-related ILD which is categorized as either UIP or NSIP pattern based on HRCT findings
2)A patient with recurrent ILD (a patient must fulfill both i. and ii.)
i. A patient has a history of RA-related ILD which was categorized as either UIP or NSIP pattern based on previous image findings (HRCT is preferable)
ii. A patient has exacerbation of ILD or ILD is considered to be active based on HRCT findings.
3)A patient with newly developed RA-related ILD which is categorized as an OP pattern based on HRCT findings.
4)A patient with recurrent RA-related ILD which is categorized as an OP pattern based on HRCT findings.
A patient who has any of the following conditions will be excluded from this study.
1. When a patient has acute exacerbation of interstitial lung disease (when a patient has acutely progressive bilateral lung infiltration and is considered to be inappropriate for the study entry by the attending physician)
2. When a patient has pulmonary hemorrhage
3. When a patient is considered to require positive pressure ventilation (positive pressure ventilation via endotracheal intubation or noninvasive positive pressure ventilation)
4. When a patient is diagnosed as having active respiratory infection or drug-induced pneumonia
5. In a case with ILD of UIP or NSIP pattern, when tacrolimus is contraindicated or a patient has ever treated with tacrolimus for ILD before
6. In a case with ILD of OP pattern, both MTX and tacrolimus are contraindicated or a patient has ever treated by either MTX or tacrolimus for ILD
7. When a patient is considered to require prednisolone with the dose of more than 0.5 mg/kg/day
8. When a patient has moderate or severe pulmonary hypertension or heart failure
9. When a patient has collagen vascular disease other than rheumatoid arthritis (Sjogren's syndrome is permissible)
10. When a patient has severe organ involvement other than interstitial lung disease
11. When a patient is considered as ineligible for this study for any reason by the attending physician
34
1st name | |
Middle name | |
Last name | Masaaki Mori |
Tokyo Medical and Dental University
Department of Lifetime Clinical Immunology
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
03-5803-4677
masaaki.mori.mm@gmail.com
1st name | |
Middle name | |
Last name | Fumio Hirano |
Tokyo Medical and Dental University
Department of Lifetime Clinical Immunology
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
03-5803-4677
hirano.rheu@tmd.ac.jp
Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Self funding
NO
東京医科歯科大学(東京都)、青梅市立総合病院(東京都)、東京都健康長寿医療センター(東京都)、横浜市立みなと赤十字病院(神奈川県)、国家公務員東京共済病院(東京都)、草加市立病院(埼玉県)、武蔵野赤十字病院(東京都)
Tokyo Medical and Dental University, Ome Municipal General Hospital, Tokyo Metropolitan Geriatric Hospital, Yokohama City Minato Red Cross Hospital, Tokyo Kyosai Hospital, Soka Municipal Hospital, Japanese Red Cross Musashino Hospital
2013 | Year | 02 | Month | 26 | Day |
Unpublished
Completed
2013 | Year | 02 | Month | 25 | Day |
2013 | Year | 02 | Month | 25 | Day |
2013 | Year | 02 | Month | 25 | Day |
2019 | Year | 03 | Month | 30 | Day |
2013 | Year | 02 | Month | 26 | Day |
2019 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011860