A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia

NCT ID: NCT02159651

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-01

Study Completion Date

2019-12-23

Brief Summary

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This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.

Detailed Description

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Conditions

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Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1: Dermatomyositis group

patients with interstitial pneumonia associated with dermatomyositis

tacrolimus

Intervention Type DRUG

oral

2: Polymyositis group

patients with interstitial pneumonia associated with polymyositis

tacrolimus

Intervention Type DRUG

oral

Interventions

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tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patient
* Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kanto, , Japan

Site Status

Kyushu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15.

Reference Type DERIVED
PMID: 35428708 (View on PubMed)

Other Identifiers

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506-MA-PRGI-01

Identifier Type: OTHER

Identifier Source: secondary_id

PRGI01

Identifier Type: -

Identifier Source: org_study_id

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