Unique ID issued by UMIN | UMIN000016320 |
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Receipt number | R000018939 |
Scientific Title | Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease |
Date of disclosure of the study information | 2015/01/24 |
Last modified on | 2018/07/27 16:18:19 |
Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
Japan |
Pulmonary arterial hypertension associated with connective tissue disease
Cardiology | Clinical immunology |
Others
NO
To investigate the effectiveness and safety of rituximab in patients with refractory pulmonary arterial hypertension associated with connective tissue disease, whose standard therapy with corticosteroid and cyclophosphamide failed
Safety,Efficacy
Efficacy:
Estimated right ventricular systolic pressure (echocardiography) and mean pulmonary arterial pressure (right heart catheterization)
Safety:
Adverse events and laboratory tests
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Weekly rituximab (375mg/m2) infusion for 4 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients with mean pulmonary arterial pressure over 25mmHg and pulmonary arterial wedge pressure under 15mmHg by right heart catheterization
2)Patients with connective tissue disease clinically suspected of pulmonary arterial hypertension associated with connective tissue disease
3)Patients with pulmonary arterial hypertension resistant to methylprednisolone pulse therapy (1 g/day for 3 days) associated with high-dose prednisolone, or high-dose oral prednisolone (over 0.8mg/kg) and intravenous cyclophosphamide therapy. Or patients with disease flare after the above therapy
1)Patients with pulmonary hypertension associated with left heart disease, chronic thromboembolic pulmonary hypertension, respiratory disease, and hypoxia
2)Patients with vasodilators (endothelin receptor antagonists, prostacyclin analogues and phosphodiesterase 5 inhibitors) started, or the dosage of the vasodilators changed within 4 weeks before the trial
3)Patients with malignancies or malignancy history within 5 years
4)Patients with sever liver diseases (AST(GOT) or ALT(GPT) over 100 U/L)
5)Patients with sever kidney diseases (serum creatinine over 3.0 mg/dL)
6)Patients with sever heart diseases
7)Patients with apparent active infectious diseases
8)Patients with hepatitis B virus carrier (patients with positive HBs antibody or HBc antibody should be monitored on their HBV-DNA monthly.(Exclude patients with history of HBV vaccination))
9)Patients with history of serious infectious diseases
6
1st name | |
Middle name | |
Last name | Yukiko Iwasaki |
The University of Tokyo Hospital
Allergy and Rheumatology
7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
03-3815-5411
yunyan-todai@umin.ac.jp
1st name | |
Middle name | |
Last name | Yukiko Iwasaki |
The University of Tokyo Hospital
Allergy and Rheumatology
7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
03-3815-5411
yunyan-todai@umin.ac.jp
The University of Tokyo Hospital
The University of Tokyo Hospital
Self funding
NO
東京大学医学部附属病院
2015 | Year | 01 | Month | 24 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 18 | Day |
2014 | Year | 09 | Month | 18 | Day |
2015 | Year | 01 | Month | 23 | Day |
2018 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018939
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