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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010126
Receipt No. 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

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Basic information
Public title Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease
Acronym Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD
Scientific Title Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease
Scientific Title:Acronym Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD
Region
Japan

Condition
Condition Interstitial lung disease related to rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Mori
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology
Zip code
Address 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Email masaaki.mori.mm@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumio Hirano
Organization Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology
Zip code
Address 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Homepage URL
Email hirano.rheu@tmd.ac.jp

Sponsor
Institute Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 25 Day
Date of IRB
2013 Year 02 Month 25 Day
Anticipated trial start date
2013 Year 02 Month 25 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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