UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015469
Receipt number R000017951
Scientific Title Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease
Date of disclosure of the study information 2014/10/18
Last modified on 2019/08/23 11:55:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name