UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease
Title of the study (Brief 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
Region	Japan

Condition
Condition	Pulmonary arterial hypertension associated with connective tissue disease
Classification by specialty	Cardiology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy: Estimated right ventricular systolic pressure (echocardiography) and mean pulmonary arterial pressure (right heart catheterization) Safety: Adverse events and laboratory tests
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Weekly rituximab (375mg/m2) infusion for 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	6

Research contact person
Name of lead principal investigator	Yukiko Iwasaki
Organization	The University of Tokyo Hospital
Division name	Allergy and Rheumatology
Address	7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	yunyan-todai@umin.ac.jp

Public contact
Name of contact person	Yukiko Iwasaki
Organization	The University of Tokyo Hospital
Division name	Allergy and Rheumatology
Address	7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	yunyan-todai@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 18 Day
Anticipated trial start date	2014 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 23 Day
Last modified on	2018 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018939