CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Tacrolimusdrug
Likely dose
Tacrolimus 0.075mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00504348
NCT00504348Phase 3Completed
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An Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical Controls

Tokyo Medical and Dental University·interventional·Posted Jul 20, 2007·Updated Mar 24, 2020

In Brief

A Phase 3 clinical trial evaluating Tacrolimus for Interstitial Pneumonitis and 2 related conditions. Completed, enrolled 25 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInterstitial Pneumonitis, Polymyositis, Dermatomyositis
CountriesJapan
CollaboratorsJapan Medical Association, Astellas Pharma Inc

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.9 years ago

Interventions

Tacrolimusdrug

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.