UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030139
Receipt No. R000034416
Scientific Title Double-Blind, parallel-group comparison, investigators initiated phase II clinical trial of IDEC-C2B8 (Rituximab) in patients with Systemic Sclerosis
Date of disclosure of the study information 2017/11/28
Last modified on 2019/05/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Double-Blind, parallel-group comparison, investigators initiated phase II clinical trial of IDEC-C2B8 (Rituximab) in patients with Systemic Sclerosis
Acronym "D"oubl"e"-Blind, parappep-group compari"s"on, "i"nvestigators initiated phase II clinical trial of IDEC-C2B8 ("R"ituximab) in pati"e"nts with "S"ystemic sclerosis
Scientific Title Double-Blind, parallel-group comparison, investigators initiated phase II clinical trial of IDEC-C2B8 (Rituximab) in patients with Systemic Sclerosis
Scientific Title:Acronym "D"oubl"e"-Blind, parappep-group compari"s"on, "i"nvestigators initiated phase II clinical trial of IDEC-C2B8 ("R"ituximab) in pati"e"nts with "S"ystemic sclerosis
Region
Japan

Condition
Condition systemic sclerosis
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of the study is to assess efficacy and safety of IDEC-C2B8 (Rituximab) in patients with systemic sclerosis (SSc).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 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)
Key secondary outcomes >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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Test Drug; IDEC-C2B8 (actual drug)
Interventions/Control_2 Control Drug; IDEC-C2B8 (placebo)
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 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
Key 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
Target sample size 56

Research contact person
Name of lead principal investigator
1st name Ayumi
Middle name
Last name Yoshizaki
Organization The University of Tokyo Hospital
Division name Department of Dermatology
Zip code 113-8655
Address 7-3-1,Hongo,Bunkyo-ku,Tokyo,113-8655,JAPAN
TEL 03-5800-8861
Email yoshizakiay-der@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Ayumi
Middle name
Last name Yoshizaki
Organization The University of Tokyo Hospital
Division name Department of Dermatology
Zip code 113-8655
Address 7-3-1,Hongo,Bunkyo-ku,Tokyo,113-8655,JAPAN
TEL 03-5800-8661
Homepage URL
Email yoshizakiay-der@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Fukui Hospital
University of Tsukuba Hospital
Cyukyo Hospital
Name of secondary funder(s) ZENYAKU KOGYO CO.,LTD.

IRB Contact (For public release)
Organization The University of Tokyo Hospital, Institutional Review Board
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5800-8743
Email rtx-office@umin.ac.jp

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(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 28 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 28 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
2017 Year 11 Month 27 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.