systemic sclerosis
Conditions
Interventions
Sponsors
The University of Tokyo Hospital
University of Fukui Hospital University of Tsukuba Hospital Cyukyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients meeting the diagnostic criteria of SSc which a revised edition in systemic sclerosis medical examination and treatment guideline 2016; the SSc patients more than 2 (moderate) disease severity of the skin induration by mRTSS. 2)Patients who are at age of 20 years or older and younger than 80 years at informed consent 3)The expectancy for life and follow-up duration > 6 months 4)Patients who meet the following conditions about a co-administered drug/combination therapy; >>No history of a dose of >10 mg of prednisolone within 2 weeks prior to the first infusion in case of having been receiving the adrenocortical steroid therapy >>No history of the dose of antifibrotic drugs (Nintedanib, Pirfenidone, Tocilizumab), the Investigational New Drugs, the immunosuppressants (Cyclophosphamide, Mycophenolate mofetil, Ciclosporin, Tacrolimus, Azathioprine, Mizoribine), intravenous immunoglobulin and Imatinib within 4 weeks before study drugs dosage 5)Having provided written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: 1)Patients who have pulmonary hypertension with SSc >The echocardiography is performed during the pretreatment period in order to confirm the complication of pulmonary hypertension. A diagnosis of the specialty department such as cardiovascular department is carried out when the pulmonary artery systolic pressure by the Doppler ultrasonography is more than 35mm Hg. 2)Patients who have serious complications (the renal crisis) other than interstitial pneumonia >With regard to interstitial pneumonia, patients who meet with the following 3) criterion will be excluded. 3)Patients who were judged that there was not enough spare ability (Less than 60%VC or less than 40%DLco calculated by newly generated prediction equation for Japanese) 4)Patients who are proved to have an HIV antibody 5)Patients that the positivity was confirmed in more than one of the HBs antigen, the HBs antibody, the HBc and HCV antibodies 6)Have serious bacterial/fungal infections 7)Have serious lung disorder 8)Have serious kidney diseases 9)Have severe heart disease 10)Have active tuberculosis 11)Have the merger of the malignant tumor, or who have the history within past 5 years 12)Have the previous history of significant infection 13)With an ingredient of this agent or serious erethism for the product derived from mouse protein or the anamnesis of the anaphylactic reaction 14)Women who are pregnant, breast feeding or positive of pregnant test 15)Patients who do not attempt to do contraception during the study period (until at least 12 months after the study end) 16)Have the disease, body condition and mental condition which make the study enforcement more difficult 17)Were administered the other investigational product within 12 weeks of the entry, or Patients who are participating in the other clinical study 18)Smoked within 12 weeks before the informed consent 19)Other patients who were judged ineligible by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute amount of change of dermal sclerosis from the pretreatment period at the 24th week after study drugs dosage in the double-blind phase by modified Rodnan Total Skin Thickness Score (mRTSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| >Measured value of %FVC, %DLco and TLC with Respiratory Function Test >The change in KL-6, SP-A, SP-D as a serum marker of the interstitial pneumonia >The change in the disease severity of the interstitial pneumonia >The thickness of the histopathology of the skin (Only when the patient consent is obtained) >An evaluation of Health-Related Quality of Life (HRQOL) by MOS 36-Item Short-Form Health Survey (SF-36) >The QOL evaluation of the generalized scleroderma patient by Health Assessment Questionnaire Disability Index (HAQ-DI) >The hematological change of the SSc-related autoantibody and antinuclear antibody (an anticentromere antibody, anti-Scl-70 (anti-topoisomerase I), anti-RNA polymerase III, anti-single stranded DNA IgG antibody, anti-double stranded DNA IgG antibody, anti-cardiolipin antibody, anti-b2-glycoprotein antibody, LAC, anti-SS-A antibody, anti-SS-B antibody, c-ANCA, p-ANCA, anti-U1-RNP antibody) >The change of serum IgG, IgM, IgA >The change in the number of serum B cells (CD19-positive cells, CD20-positive cells) and T cell (CD3-cells) >The presence or absence of the expression of the human anti-chimeric antibody (HACA) Safety endpoints >The incidence, disease severity, causal relationship, an outcome of all adverse events >The incidence and disease severity of infusion reaction >The change in the clinical laboratory parameters, vital signs, body weight, the electrocardiogram and echocardiographic findings Other endpoints >Pharmacokinetic profiles >Calculate the following pharmacokinetic profile parameters: area under the concentration-time curve (AUC0-t), maximum drug concentration (Cmax), maximum drug concentration time (Tmax), half-life period (t1/2), mean residence time, clearance, distribution volume | — |
Countries
Japan
Contacts
Public ContactAyumi Yoshizaki
The University of Tokyo Hospital Department of Dermatology
Outcome results
None listed