UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016320
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

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Basic information

Public 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

Acronym

Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Yukiko Iwasaki

Organization

The University of Tokyo Hospital

Division name

Allergy and Rheumatology

Zip code


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

1st name
Middle name
Last name Yukiko Iwasaki

Organization

The University of Tokyo Hospital

Division name

Allergy and Rheumatology

Zip code


Address

7-3-1 Hongou, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

yunyan-todai@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name