anti-melanoma differentiation-associated gene 5 antibody-positive dermatomyositis dermatomyositis / anti-melanoma differentiation-associated gene 5 antibody
Conditions
Interventions
Investigational drug: Tofacitinib
Tofacitinib 5mg/tablet is administered twice daily, one tablet at a time.
The dose may be increased to two tablets of tofacitinib 5 mg/tablet twice daily at the discr
Tofacitinib / Corticosteroids / Tacrolimus / Cyclophosphamide
Sponsors
Furuta Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18 and over (regardless of gender) 2.Patients with newly diagnosed dermatomyositis who meet the criteria of Bohan and Peter as probable/definite or clinically amyopathic dermatomyositis who meet Sontheimer's criteria 3.Patients with a positive test for anti-MDA5 antibody within 28 days prior to the start of trial drug administration 4.Patients with interstitial pneumonia on chest X-ray or CT 5.Patients with any one of the following conditions A, B, or C ARapidly progressive interstitial pneumonia BOxygen saturation is less than 95% CSerum ferritin level at screening is 500 ng/mL or higher 6.Patients who have been adequately informed of the trial and who have provided written consent, either of their own volition or through their legal representative, are considered to have given their free and informed consent
Exclusion criteria
Exclusion criteria: 1.Patients who received corticosteroids within 4 weeks (28 days) prior to the start of the investigational drug 2.Patients who received immunosuppressive drugs other than corticosteroids, TNF inhibitors, IL-6 inhibitors, anti-CD20 monoclonal antibodies, JAK inhibitors, intravenous immunoglobulin or plasma exchange therapy within 12 weeks (84 days) prior to the start of the investigational drug 3.Patients with a history of hypersensitivity to the investigational drugs 4.Patients with uncontrolled complications 5.Patients with serious infections 6.Patients with HIV infection, hepatitis B virus, hepatitis C virus infection or a history of such infection 7.Patients with active tuberculosis 8.Patients with AST or ALT greater than 3 times the upper limit of the institutional reference value 9.Patients with a neutrophil count less than 500/mm2 10.Patients with a lymphocyte count less than 500/mm2 11.Patients with a hemoglobin level less than 8 g/dL 12.Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating 13.Other patients who are judged by the investigator or sub-investigator to be inappropriate for the safe conduct of this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints 1.Percentage of cytomegalovirus infection and cytomegalovirus disease 2.Percentage of adverse events 3.Percentage of serious adverse events Efficacy endpoints 1.The percentage of patients who did not require concomitant restricted medications or restricted therapies during the interval between the initiation of trial drug administration and 12 weeks post-initiation, and who were alive at 12 weeks post-initiation. 2.The percentage of patients who remained progression-free for at least 12 weeks following the administration of the trial drug 3.Transition of HRCT score, %FVC, %DLCO, and P/F ratio 4.Total dose of corticosteroids during the trial period 5.Corticosteroid dosage after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Transition of blood test values 2.Tofacitinib drug blood concentration 3.Analysis of the relationship between tofacitinib blood drug concentration and efficacy endpoints 4.Analysis of the relationship between tofacitinib blood drug concentration and safety endpoints 5.Analysis of the relationship between the number and type of poor prognostic factors and efficacy endpoints | — |
Contacts
Public ContactAsahi Takahashi
Chiba University Hospital
Outcome results
None listed