Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000015469
• Date of registration: 18/10/2014
• Prospective Registration: Yes
• Primary sponsor: Second Division, Department of Internal medicine, Hamamatsu University School of Medicine
• Public title: Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease
• Scientific title: Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD
• Date of first enrolment: 2014/10/20
• Target sample size: 50
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017951
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Tomoyuki Fujisawa
• Affiliation: Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

• Name: Takafumi Suda
• Affiliation: Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 18years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease

Intervention(s)

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.
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.

Primary Outcome(s)

Progression free survival rate at week 52

Secondary Outcome(s)

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.

Source(s) of Monetary Support

none

Ethics review

Status: YES
Approval date: 05/06/2014
Contact:

Results

• Results available: Yes
• Date Completed: 01/04/2019