UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease
Acronym	Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD
Scientific Title	Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease
Scientific Title:Acronym	Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD
Region	Japan

Condition
Condition	polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare the efficacy and safety between tacrolimus/predonisolone therapy and cyclosporine/predonisolone therapy for polymyositis/dermatomyositis-associated interstitial lung disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival rate at week 52
Key secondary outcomes	Overall survival rate at week 52 Change in forced vital capacity from baseline at week 52. Change in DLCO, 6MWT,PaO2, KL-6 and SP-D from baseline at week 4, 12, 24 and 52.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.
Interventions/Control_2	arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml.
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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	The diagnosis of PM or DM was based on the criteria of Bohan and Peter criteria: 1) systemic muscle weakness, 2) increased serum muscle enzyme levels, 3) electromyographic (EMG) evidence of myopathic changes, 4) typical histologic findings in muscle biopsies, and/or 5) characteristic dermatologic manifestations of DM. The diagnosis was considered definite, probable, or possible according to the number of criteria fulfilled (at least 4, 3, or 2, respectively, including the dermatologic manifestations for diagnosis of DM), and patients with definite or probable PM/DM were included in the study. CADM was diagnosed when a patient had a skin rash characteristic of DM without clinical evidence of muscle disease and with little or no increase in the serum creatine kinase (CK) level. Interstitial lung disease was diagnosed on the basis of the presence of high resolution computed tomography abnormalities in combination with one or more of the following; dyspnea on exertion, serum KL-6 level > 500 U/ml, arterial oxygen tension (PaO2) < 80mmHg, %FVC < 80%, %DLCO < 65%.
Key exclusion criteria	Patients who met the following criteria are excluded from this study: (i) no evidence of deterioration in interstitial lung disease for more than 6 months; (ii) the presence of a serious comorbidity (e.g. malignancy, liver dysfunction, and renal dysfunction); (iii) use of immunosuppressants (except for corticosteroid), intravenous immunoglobulin therapy, plasma exchange.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoyuki Fujisawa
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL	053-435-2263
Homepage URL
Email	fujisawa@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 18 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	2014 Year 03 Month 20 Day
Date of IRB	2014 Year 06 Month 05 Day
Anticipated trial start date	2014 Year 10 Month 20 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 18 Day
Last modified on	2019 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017951