UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017217 |
|---|---|
| Receipt number | 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 16:20:01 |
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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
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
tahara.masayuki.ne@mail.hosp.go.jp
Sponsor or person
Institute
Clinical Research Center, Utano National Hospital, National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019971
