Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Interstitial PneumonitisPolymyositisDermatomyositis
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.

Trial Locations (11)

060-8648

Hokkaido University Hospital, Sapporo

305-8576

Tsukuba University Hospital, Tsukuba

586-8521

Osaka Minami Medical Center, Kawachi-Nagano

113-8431

Juntendo University Hospital, Bunkyo-ku

113-8519

Tokyo Medical and Dental University Hospital, Bunkyo-ku

113-8655

The University of Tokyo Hospital, Bunkyo-ku

160-8582

Keio University Hospital, Shinjuku-ku

162-8655

International Medical Center of Japan, Shinjuku-ku

260-8677

Chiba University Hospital, Chiba

852-8501

Nagasaki University Hospital of Medicine and Dentistry, Nagasaki

770-8503

Tokushima University Hospital, Tokushima

All Listed Sponsors
collaborator

Japan Medical Association

INDUSTRY

collaborator

Astellas Pharma Inc

INDUSTRY

lead

Tokyo Medical and Dental University

OTHER