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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017217
Receipt No. R000019971
Scientific Title An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica
Date of disclosure of the study information 2015/04/21
Last modified on 2019/03/29

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Basic information
Public title An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica
Acronym RIN-2
Scientific Title An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica
Scientific Title:Acronym RIN-2
Region
Japan

Condition
Condition Neuromyelitis optica
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the long-term effectiveness of rituximab against relapses of neuromyelitis optica
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Safety
Key secondary outcomes Changes of Expanded Disability Status Scale (EDSS) and Quantification of Optic nerve and Spinal cord Impairment (QOSI) from the baseline score, and the proportion of steroid-free patients

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 Rituximab intravenous infusion
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Participants in the RIN-1 study who meet all of the following criteria can be included. 1) Patients who have completed the RIN-1 study and have been stable for at least 4 weeks if having relapses in the RIN-1 study.
2) Women of childbearing ages who are negative for a pregnancy test on Visit 1 and consent avoidance of the pregnancy during the trial.
3) Patients who give written informed consent. Patients under 20 years of age are require parental consent. 4) Patients who are able to follow the study protocol and schedule and who can report their symptoms.
Key exclusion criteria 1) Patients who have completed RIN-1 study 6 months ago or earlier.
2) Patients who required to continue acute-phase treatments such as methylprednisolone pulse therapy or plasma exchange.
3) Patients treated with oral corticosteroid more than 30 mg per day (in prednisolone conversion).
4) Patients with hypersensitivity to mouse protein derivatives or those with a history of anaphylactic reaction to components of rituximab.
5) Patients infected with HBV, HCV, or HIV, those with an active infectious diseases, or those with a history of severe chronic or recurrent infections.
6) Patients who received a monoclonal antibody (e.g., natalizumab or rituximab, except for rituximab use according to the protocol in the RIN-1 study), cladribine, radiation treatment (whole-body irradiation or lymphoid irradiation), stem-cell transplant, mitoxantrone, cyclophosphamide infusion, immunoglobulin therapy, immunomodulatory drugs (interferon beta, glatiramer acetate), oral immunosuppressive agents other than steroids (e.g., azathioprine, tacrolimus, cyclosporine, cyclophosphamide, methotrexate, or fingolimod), or live vaccines within 6 months before Visit 1.
7) Patients with autoimmune diseases, such as Sjogren's syndrome or systemic lupus erythematosus, requiring treatment with immunosuppressants.
8) Patients who are pregnant or feeding a baby.
9) Patients who are participating in other clinical trials for NMO.
10) Patients diagnosed as having a cancer.
11) Patients who are considered unfit for the enrollment in the trial after an investigation.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Tahara
Organization Utano National Hospital
Division name Clinical Research Center
Zip code 6168255
Address 8 Ondoyma-cho, Narutaki, Ukyo-ku, Kyoto
TEL 075-461-5121
Email tahara.masayuki.ne@mail.hosp.go.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Tahara
Organization Utano National Hospital
Division name Clinical Research Center
Zip code 6168255
Address 8 Ondoyma-cho, Narutaki, Ukyo-ku, Kyoto
TEL 075-461-5121
Homepage URL
Email tahara.masayuki.ne@mail.hosp.go.jp

Sponsor
Institute Clinical Research Center, Utano National Hospital, National Hospital Organization
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development, AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Zenyaku Kogyo Co., Ltd.
Name of secondary funder(s) Zenyaku Kogyo Co., Ltd. (2018.4.1-)

IRB Contact (For public release)
Organization NHO Utano National Hospital
Address 8 Ondoyama-cho, Narutaki, Ukyo-ku, Kyoto
Tel 075-461-5121
Email mori.yosuke.kc@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 21 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 33
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 04 Month 17 Day
Date of IRB
2014 Year 04 Month 18 Day
Anticipated trial start date
2015 Year 04 Month 21 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
2019 Year 03 Month 29 Day
Date trial data considered complete
2019 Year 03 Month 29 Day
Date analysis concluded
2019 Year 03 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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