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Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus

NCT00504348 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-24

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and safety of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis with comparison against corticosteroid-treated historical controls.

Conditions

  • Interstitial Pneumonitis
  • Polymyositis
  • Dermatomyositis

Interventions

DRUG

Tacrolimus

Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.

Sponsors & Collaborators

  • Japan Medical Association

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Tokyo Medical and Dental University

    lead OTHER

Principal Investigators

  • Nobuyuki Miyasaka, MD, PhD · Tokyo Medical and Dental University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504348 on ClinicalTrials.gov